Ethics Handout-Do No Harm, Equity, Informed Consent, Confidentiality PDF

ABCDE Ethical Principles: Do No Harm; Equity PT 8351 Matt Garber, PT, DSc Board Certified Orthopaedic Clinical Specialist Fellow, AAOMPT Associate Professor The George Washington Unive...

ABCDE Ethical Principles: Do No Harm; Equity PT 8351 Matt Garber, PT, DSc Board Certified Orthopaedic Clinical Specialist Fellow, AAOMPT Associate Professor The George Washington University Objectives 1. Identify examples of do-no-harm (non-malfeasance) and health equity in health care. 2. Apply concepts of do-no-harm and equity to the practice of physical therapy. 3. Consider the broader societal influences that impact "Equity" in health care. Portions of this presentation adapted from Dr. Rhea Cohn Types of Situations Not all are ethical dilemmas 5 Major Types of Ethical Situations (Purtilo, 2005) Issue/problem — Important values are present or may be challenged. Dilemma — Two alternative courses of action; each fulfills an important duty and it is not possible to fulfill both obligations. Distress — You know the right course of action but are not authorized or empowered to perform it. Temptation— Involves a choice between a “right” and a “wrong,” and in which you may stand to benefit from doing the wrong thing. Silence — Ethical values are challenged, but no one is speaking about this challenge to values. Individual Processes Being ethical is more than just knowing and deciding – it can be placing moral motivation above other values: Overlapping, simultaneous, not necessarily sequential (James Rest,1994) Ethical Sensitivity Recognizing and interpreting ethical situations. Ethical Judgment Judging which action is right or wrong. Ethical Courage/Character Prioritizing ethical values over other values. Demonstrating courage, persisting, and implementing. Developing and negotiating a plan of action. First, Do No Harm Primum non nocere "I will abstain from all intentional wrong-doing and harm" Definitions malfeasance is wrongdoing while maleficence is harmfulness or mischief You may see these terms used interchangeably  https://khn.org/news/so-much-care-it-hurts-unneeded-scans-therapy-surgery-only-add-to-patients-ills/ https://www.journals.uchicago.edu/doi/pdf/10.1162/AJHE_a_00069 https://khn.org/news/1-in-3-recent-fda-drug-approvals-followed-by-major-safety-actions/ https://khn.org/news/putting-a-lid-on-waste-needless-medical-tests-not-only-cost-200b-they-can-do-harm/  choosingwisely.org Four out of every ten patients are harmed during primary and ambulatory health care. The most detrimental errors are related to diagnosis, prescription and the use of medicines. Medication errors alone cost an estimated US$ 42 billion annually. Unsafe surgical care procedures cause complications in up to 25% of patients resulting in 1 million deaths during or immediately after surgery annually. Choosing Wisely—5 Questions to Ask Before Any Test, Treatment or Procedure Do I really need this test or procedure? What are the risks and side effects? choosingwisely.org Are there simpler, safer options? What happens if I don’t do anything? How much does it cost, and will my insurance pay for it? 'Bedrest is Bad': New #everyBODYmoves recommends-against-arthroscopy-for-nearly-all-patients-with-knee- Campaign Combats Hospital Immobility https://www.apta.org/news/2017/05/12/bmj-guideline-strongly- https://www.apta.org/article/2019/07/01/bedrest-is-bad-new- everybodymoves-campaign-is-combatting-hospital-immobility oa-or-meniscal-tears The guideline, published online May 10, 2017, in BMJ, is based on a 2016 systematic review that indicated outcomes for knee arthroscopy were no better than those for exercise in people with degenerative medial meniscus tear. The multidisciplinary, international panel included physical therapists, orthopedic surgeons, a rheumatologist, a general practitioner, general internists, epidemiologists, methodologists, and patients. Patient Bill of Rights https://www.americanpatient.org/aha-patients-bill-of-rights/ https://www.cms.gov/CCIIO/Programs-and-Initiatives/Health- Insurance-Market-Reforms/Patients-Bill-of-Rights Refers to what a patient is guaranteed while receiving care Respectful care Full information and consent Advanced directives Privacy/confidentiality Examples of Harm in Health Care Sports medicine: (e.g. limited or no screening for concussion) Unethical medical research (e.g. Guatemala, 1946; Tuskegee syphilis experiment 1953; use of prisoners, children, unknowing citizens,) Excessive use of antibiotics despite evidence Hospital acquired pressure ulcers and infections Patient genomic testing information that is not medically actionable Use of “chemical restraints” in nursing homes Inappropriate use of opioids Inadequate hand washing/PPE leading to infection Other Examples Physical abuse of patients Providing excessive care that is not indicated Improper referrals that promote secondary financial gain Identity theft for financial gain Revealing of private health information (PHI) Financial abuse of seniors PT Examples Use of contraindicated modalities Patient injury from manual therapy/manipulation Not checking a patient’s skin for breakdown Not performing routine maintenance checks on equipment Not properly monitoring patients on exercise equipment Not washing our hands between patients or attending to precautions Being impaired by drugs or alcohol Allowing a fall to happen because of inadequate guarding Inappropriately handing off care to another person Inadequate or inaccurate documentation APTA Code of Ethics Principle #3: Physical therapists shall be accountable for making sound professional judgments. (Collaboration, Duty, Excellence, Integrity) Principle #4: Physical therapists shall demonstrate integrity in their relationships with patients/clients, families, colleagues, students, research participants, other health care providers, employers, payers and the public. (Integrity) Principle #7: Physical therapists shall promote organizational behaviors and business practices that benefit patients/clients and society. (Integrity, Accountability) Moral Agency Health Care providers held to a higher standard of accountability Responsibility to do what is right Patients are vulnerable and many times less knowledgeable Patients believe we have their best interests in mind Patients TRUST us—do not jeopardize this Dual Loyalty Conflicting demands on health professionals who have obligations to their patients and to states or other parties. Such conflicts can give rise to an array of ethical and human rights challenges, particularly in settings in which governments or their agents are engaged in ongoing rights violations. Provision of care at US Detention Facilities at the Mexican border Protection of patient privacy when a spouse may be harmed by being uninformed. Conflict for providers torn between personal and professional senses of what is right and pressures from outside parties with competing demands and agendas. Exceptions to Confidentiality the potential harm to identifiable third parties is serious the likelihood of harm is high there is no less-invasive alternative means for warning or protecting those at risk breaching confidentiality allows the person at risk to take steps to prevent harm harms resulting from the breach of confidentiality are minimized and acceptable https://journalofethics.ama-assn.org/article/physicians-dual-loyalties/2005-06 Risk Management Strategies Recognize when the potential for harm exists. Refrain from abuse. Don’t take advantage of the patient’s vulnerabilities. Be sensitive to the perceived difference in “power” between the patient and the clinician. Consider health care disparities related to access, treatment decision choices, literacy level, and financial constraints. Stop and think before you speak. Seek help. http://healthliteracymap.unc.edu/ Impact of low health literacy more hospitalizations greater use of emergency rooms lower receipt of vaccinations and mammograms reduced medication adherence poorer ability to interpret health messages among the elderly, poorer health status and higher mortality rates less use of preventive services Berkman et al, Low health literacy and health outcomes: an updated systematic review (2011) Equity Health Equity The state in which everyone has the opportunity to attain full health potential and no one is disadvantaged from achieving this potential because of social position or any other socially defined circumstance. Only 8 % of US residents over age 35 receive recommended preventive care Blood pressure Cholesterol Breast, colon, cervical cancer Osteoporosis PSA Tobacco/alcohol use Obesity Depression Vaccinations and flu shots, herpes zoster, pneumococcal National Center for Health Statistics (2018) National Academies of Science: “Communities in Action: Pathways to Health Equity” Conclusion 3-2: “Based on its review of the evidence, the committee concludes that health inequities are the result of more than individual choice or random occurrence. They are the result of the historic and ongoing interplay of inequitable structures, policies, and norms that shape lives.” Health Equity Impact of cost of healthcare 15% insured but struggle to afford; 11% uninsured 1/3 of those in fair to poor health have insurance but struggle to afford Addressing Health Equities Does your organization focus on selective disadvantaged groups? Have you considered how you can reduce health disparities in your community? What should you consider as a provider of health care services? Who can be a new partner to help build your community and improve health at the same time? Access to PT Current legislative initiatives related to access to PT services: Direct Access legislation Access to Medicare services without physician certification Adding PTs to the National Health Service Corps (NHSC) Loan Repayment Program Payments for telehealth provided by physical therapists  https://www.apta.org/apta-and-you/news-publications/podcasts/2019/aptas- 2019-2020-public-policy-priorities APTA Efforts Clinical Considerations for Equity Hours/days of operation Family friendly waiting areas and/or on site day care Situating clinics near public transport; universal design for accessibility Open scheduling to allow for last minute client availabilities Non judgmental, welcoming atmosphere Appropriate health literacy policies Multi-lingual signage and handouts, interpreters Appropriately worded health intake/screening forms Staff sensitivity to diversity needs Diverse selection of magazines Inclusion of varied community resources in waiting room Gender neutral bathrooms  Informed Consent Professional Issues in Physical Therapy Health Care Management I PT 8351 1 Objectives Describe parameters of informed consent in physical therapy practice. Link informed consent to the ethical principle of autonomy. Recognize how cultural and health literacy level differences impact the process of informed consent. 2 Examples of informed consent in daily life Bank/loan documents Websites and apps Personal or family genetic history Consent for medical care 3 What is “informed consent” Informed consent is the process by which a treating health care provider discloses appropriate information to a competent person so that he/she may make a voluntary choice to accept or refuse treatment.* The process should include: Nature of decision/procedure Reasonable alternatives to the proposed intervention Relevant risks, benefits, and uncertainties related to the alternatives Assessment of patient understanding Acceptance of the intervention by the patient Costs of the intervention and timeframes Possible treatment alternatives This is at the “core” of autonomy! 4 *Adapted from: https://depts.washington.edu/bioethx/topics/consent.html Based on the previous definition, do you think the following is “informed consent”? “Hello Mrs. Smith. My name is Joe Harrison and I am a student physical therapist at George Washington University. May I work with you today?” 5 Three considerations: Competency: Patient or his/her surrogate must be competent. Coercion: Patient must be participatory in the decision rather than just signing a form. Comprehension: Patient must understand the information that is presented in layperson’s language. 6 Health Literacy: A patient’s perspective 7 Examples of Unethical Research 8 https://en.wikipedia.org/wiki/Unethical_human_experimentation_in_the_United_States Global Response Nuremberg Code – 1947 Absence of coercion Properly formulated scientific experimentation Informed consent Declaration of Helsinki – (similar principles) Most recently updated 2024 National Research Act (1974) Funded what would become the Belmont Report (1979) which established guidelines for informed consent, beneficence, justice, assessment of risks and selection of test subjects. 9  Attitudes toward medical research “If you give consent, then you don’t have any legal rights. When you sign that paper, you sign all of your rights away because they have disclaimers all neatly typed up, reviewed by their lawyers to protect themselves from being sued.” Category Words Trust Being lied to, corruption, deception, negligence, using people Harm Sacrifice, cruelty Science/Research Experiment, trial and error, searching for more knowledge, progress, learning how to treat problems, finding a cure Belief Guinea pig, necessary 10 Corbie-Smith et al. Attitudes and Beliefs of African Americans Toward Participation in Medical Research. J Gen Intern Med 1999; 14:537-546.  Schachter CL, Stalker CA, Teram E. Toward sensitive practice: issues for physical therapists working with survivors of childhood sexual abuse. Phys Ther. 1999;79(3):248-61. PMID: 10078769 Silhoven R, Paavola M, Malmivaara A, et al. Arthroscopic partial menisectomy versus sham surgery for a degenerative meniscal tear. N Engl J Med. 2013;369(26):2515-24. PMID: 24369076 11 HeLa Who does genetic information belong to? The individual or the family?* Henrietta Lacks, National Portrait Gallery Skloot, R. (2010). The immortal life of Henrietta Lacks. New York, NY: Crown. 12 Challenges with Informed Consent What populations may be impacted the most? Young Mentally impaired Unconscious Frail Confused Temporary incapacity (emergencies) Those who have language and cultural barriers Use of surrogates: Hierarchy of surrogates is defined by state law If no surrogate is available, physician is supposed to act in the best interest of the patient (beneficence). 13 In some instances, a court ordered surrogate is appointed. Legal Guidepost Example: Maryland Regulations Section 10.38.03.02 - Standards of Practice A.2.(c) “The physical therapist shall provide the patient with accurate information about the physical therapy services provided.” Note: The term “informed consent” is not used! 14 Legal Guidepost Example: District of Columbia Regulations 6716.6: A physical therapist who performs intramuscular manual therapy shall obtain written informed consent from each patient who will receive intramuscular manual therapy before the physical therapist performs intramuscular manual therapy on the patient. 6716.7 The informed consent form shall include, at a minimum, the following: (a) The patient’s signature; (b) The risks and benefits of intramuscular manual therapy; (c) The physical therapist’s level of education and training in intramuscular manual therapy; and (d) A clearly and conspicuously written statement that the patient is not receiving acupuncture. 15 http://doh.dc.gov/sites/default/files/dc/sites/doh/publication/attachments/Physical_Therapy_DC_Municipal_Re gulations_for_Physical_Therapy.pdf Guidepost: APTA Code of Ethics Principle #2: Physical therapists shall be trustworthy and compassionate in addressing the rights and needs of patients/clients. #2C: Physical therapists shall provide the information necessary to allow patients or their surrogates to make informed decisions about physical therapy care or participation in clinical research. Note: The term “informed consent” is not used! 16 Informed consent is a Risk Management tool 17 http://www.hpso.com/Documents/pdfs/CNA_CLS_PTreport_final_011312.pdf page 20. Informed consent in practice When does it occur? Should it happen more than once? Who is involved? What is stated? Where are the risks? How should you manage YOUR risk? 18 Tips for Practice Informed consent laws differ by state. Refer to the state statutes and regulations. Include in documentation: You provided information regarding the proposed treatment (POC). The patient demonstrated they understood the information. The patient gave consent to the proposed treatment (POC). 19 Discussion: How informed is your patient’s consent? 20 APTA Magazine. November 2022. https://www.apta.org/apta-magazine/2022/11/01/ethics-in-practice Items for discussion Legal versus ethical informed consent Was enough information provided? What was the patient’s understanding? Was consent ongoing? Was the patient’s autonomy respected? 21 Discussion Based on your previous experiences, identify a scenario related to informed consent where the therapist may have been at risk? 22 What have you learned about informed consent? 23 Summary 24  Patient Confidentiality Professional Issues in Physical Therapy Health Care Management I PT 8351 1 Objectives Student will: Discuss patient confidentiality related to physical therapist practice. Apply HIPAA to patient care. Describe parameters of informed consent in physical therapy practice. Link informed consent to the ethical principle of “autonomy”. Recognize how cultural and health literacy level differences impact the process of informed consent. 2 Patient Confidentiality “Three may keep a secret if two of them are dead.” Ben Franklin (1735) 3 What is “confidentiality” https://www.cdc.gov/aging/emergency/legal/privacy.htm Federal Law: The right to privacy granted by HIPAA (1996) gives legal standing to this ethical principle. Balances protections for the individual with what is needed for appropriate care. Protected health information (PHI) is oral, electronic, or paper-based. 4 Question: Do you see the principle of “autonomy” here? https://www.hhs.gov/hipaa/for-professionals/privacy/laws-regulations/index.html Jurisdiction level guidance: Maryland Code of Ethics (example) “The physical therapist and physical therapist assistant shall protect the patient’s right to privacy by not divulging confidential information without consent of the patient or guardian unless required by law.” 5 https://health.maryland.gov/bphte/Pages/comar.aspx#chap2 DC Standards of Conduct (6714.1) “The physical therapist shall protect the patient’s right to privacy by not divulging confidential information without consent of the patient or guardian unless required by law or unless, in the judgment of the physical therapist, the information is needed to protect the patient or the community.” Question: Do you see language here that supports the “individual” and “societal” realms? 6 Professional association level guidance: APTA: Code of Ethics Principle #2: Physical therapists shall be trustworthy and compassionate in addressing the rights and needs of patients/clients. 2E. Physical therapists shall protect confidential patient and client information and may disclose confidential information to appropriate authorities only when allowed or as required by law. 7 Facility level guidance: example 8 https://mycare.gundersenhealth.org/JobShadow/doc/confid_policy.pdf What is HIPAA? Health Insurance Portability & Accountability Act ⮚Federal law Signed into law in 1996 Administered through the US Department of Health and Human Services, Office of Civil Rights ⮞ This means HIPAA is for protection, health, and antidiscrimination Important HIPAA Definitions Privacy – state of being concealed; secret Confidential – containing private information (e.g., medical record) Authorization – to give permission for; to grant power to Confidentiality breach – to break an agreement, to violate a promise Disclosure – the release, transfer, provision of access to, or divulging of information outside the entity holding the information 1. Privacy Rule Protected health information 1. Name 10. Account # 2. Address (smaller than 11. Certificate/license # state) 12. Driver’s license or license plate # 3. Date 13. Device ID and serial # 4. Phone # 14. Web URL 5. Fax # 15. IP address 6. Email address 16. Finger print 7. Social security # 17. Full face photo 18. Any other unique ID # or 8. Medical record # characteristic that could 9. Health insurance reasonably be associated with beneficiary # the individual 1. Privacy Rule When can we disclose protected health information? ⮚Treatment ⮚Payment* ⮚Operational/organizational activities* Fraud and abuse detection Quality improvement measures Competency assessments *Use the Minimum Necessary Standard 1. Privacy Rule Administrative Requirements ⮚Policies and procedures ⮚Privacy personnel ⮚Training and management ⮚Mitigation ⮚Data safeguards ⮚Complaints ⮚Retaliation and waiver ⮚Documentation and record retention 2. Security Rule Specific to electronic protected health information ⮚Confidentiality No one can access protected health information without authorization ⮚Integrity No one should alter or destroy without authorization ⮚Availability Accessible and useable on demand by authorized personnel 2. Security Rule Must maintain reasonable and appropriate safeguards ⮚Administrative Safeguards Policies and procedures, security officer, training, privacy notices, discipline ⮚Physical Safeguards Lock and key, security, cameras Data backup, removal, and disposal ⮚Technical Safeguards Moving workspaces to private areas Logging out Never sharing passwords Never emailing sensitive information Technology security, encrypting hard drives 3. Breach Notification Rule Incidental disclosure ⮚When it is unavoidable and occurs during compliant activity ⮚Someone at a hospital overhears a confidential conversation between a provider and a patient, or another provider ⮚A patient may see a glimpse of another patient’s information on a whiteboard or sign-in sheet ⮚An individual may see another person’s x-ray at a hospital ⮚Conversations between nurses may be overheard by those walking past a nurses’ station ⮚Do not report, not considered a true breach 3. Breach Notification Rule Accidental disclosure ⮚Mistakenly disclose private health information Sending an email or faxing to the wrong recipient Provider accidentally viewing a patient's report ⮚Learn from it, assist in correcting the issue ⮚Must disclose to privacy officer, considered a breach 3. Breach Notification Rule Intentional disclosure ⮚Ignore the rules and carelessly or deliberately use or disclose private health information ⮚Subject to civil and criminal charges ⮚Must disclose to privacy officer, considered a breach Breaches of confidentiality How and where do breaches happen? Nurses stations Discussions in elevators Electronic devices that are not secure Records left out at night Cabinets not locked Inappropriate use of social media Happy hours Eavesdropping Patients seeking information about other patients Social media 19 Patient sharing of private information Patients share Patients DON’T share They feel it will positively Embarrassment and impact the care they are shame: Loss of dignity receiving. They believe it helps to Worry or concern about solidify a trusting ramifications (e.g. loss of relationship. insurance coverage, discrimination) They feel vulnerable. Worry of being judged. 20  13% respondents reported having withheld medical information from providers because of privacy concerns. What should we do: Have honest conversations with your patient about the electronic health record. Help patients understand how the electronic record may favorable impact the value of the care they receive. 21 (2014) https://academic.oup.com/jamia/article/22/e1/e130/701682/  A provider is permitted to share patient information with someone if the information has relevance to that person’s role in the care of the patient. Use the “Need to Know” test. Do No HARM! Use the “minimum necessary” rule: A covered entity must make reasonable efforts to use, disclose, and request only the minimum amount of protected health information needed to accomplish the intended purpose of the use, disclosure, or request 22 TIP: Don’t get caught divulging your own personal information! Privacy Exceptions: Emergencies when patient would be harmed by not releasing information. Patient is incompetent or incapacitated and a third party needs to be informed to make a decision. Third parties are at risk for harm (e.g. spouses for sexually transmitted diseases, child abuse) Conflict between autonomy and do-no-harm Federal exceptions during natural disasters. Rule of thumb: Minimize exceptions! The burden of proof is always on the health professional to minimize 23 harm. Patient records and confidentiality Do you see a conflict between the increased risk of breach of confidentiality with Electronic Medical Records (EMRs) versus the potential benefit of improved access to patient records by more people? It is a HIPAA violation for an employee of a health care organization to look up information in the EMR if there is no reason to access that patient’s EMR. When this might happen? 24 HIPAA VIOLATIONS/BREACH Breach: “an impermissible use or disclosure under the Privacy Rule that compromises the security or privacy of the protected health information.” The penalties for noncompliance are based on the level of negligence and can range from $100 to $50,000 per violation (or per record), with a maximum penalty of $1.5 million per year for violations of an identical provision. 25 https://www.hhs.gov/hipaa/for-professionals/breach-notification/index.html Confidentiality Scenario #1 A patient sustained a spinal cord injury in a car accident and confides that they are saving their pain medication to commit suicide. What ethical principles are involved? Who should be involved? What would you do? How would you approach this problem? 26 Confidentiality Scenario #2 A patient with metastatic cancer affecting vision and coordination does not want to give up his driver’s license. His wife agreed with the patient because she didn’t want to upset him, despite medical advice. What ethical principles are involved? Who should be involved? What would you do? How would you approach this problem? 27 Gaertner, J. et al. Denying a Patient’s Final Will: Public Safety vs. Medical Confidentiality and Patient Autonomy (2011) Driving: State laws determine duty to inform Six states mandate physicians to report potentially unsafe drivers. 22 states have protocols for physician reporting but do not require it. 44 states allow a family member to report. Approximately 5 states permit health care professionals, including PTs, to report potentially unsafe drivers (CT, FL, MI, TX, WI); full or partial immunity in all but CT -What ETHICAL PRINCIPLES are in conflict? 28 -What REALMS are involved? If you are involved in advising a physician about a patient’s status for driving, documentation is your protection! “To protect yourself legally, you should document your efforts, conversations, recommendations, and any referrals for further testing in the patient’s chart……” Know your state laws! Some states have different drivers’ license requirements for “seniors”. Note: See resources in Blackboard! 29  Summary for confidentiality: Protect yourself and your patient 1. Confirm the patient’s identity at the first encounter. 2. Never discuss the patient’s case with anyone without the patient’s permission (including family and friends) other than necessary providers. 3. Never leave records, computer screens, where unauthorized persons may access them. 4. Use only secure (e.g encrypted) routes to send patient information. Be careful about apps! If it is unencrypted, make sure you have patient permission in writing. 5. When using a qualified interpreter, attempt to ensure that he/she understands the importance of patient confidentiality. 6. Track changes in telehealth, both the technology as well as the 30 jurisdiction regulations. In the clinic 1. Conduct patient interviews in private rooms if possible. 2. Never discuss cases or use patients’ names in public areas. (You are permitted to call a patient by name to come into clinic). 3. Do not release information unless you are sure that the person receiving the information has the authority to obtain that information. 4. Don’t share patient information with other patients! 31 Record management: HIPAA security 1. Keep records that contain patient information in locked files. 2. Restrict access to electronic databases. 3. Protect computer passwords 4. Safeguard computer screens 5. Keep computers in a locked area 6. Manage “print outs” with patient information as you would with all patient records. 7. Minimize or eliminate need to take portable electronic devices out of the clinic. 32