Medical Law and Ethics (HOSA)

Medical Practice Act

A state law applying specifically to the way medicine can be practiced in a particular state. They also define what constitutes unprofessional behavior, commonly including:

-Practicing without a license

-Impaired ability to practice due to illness or addiction

-Insufficient record keeping

-Allowing an unlicensed person to practice

-Physical abuse of patients

-excessive prescription amounts

Utilitarianism

Ethical theory based on what is the greatest good for the greatest number of people. The ends justify the means. Can lead to a biased allocation of resources, ignoring the rights of vulnerable people.

Rights-Based Ethics

Primary emphasis on a person's individual rights. Rights belong to all people purely on the basis of their humanity. Includes freedom of speech, due process, equal rights to organs, etc. Can encourage individualist behavior.

Duty Based Ethics

ALL must adhere to laws, keep promises, be honest, and make reparations. It is our duty as medical professionals to our patients. Hard to determine who should determine the rules of moral behavior.

Justice Based Ethics

Impartial decisions. "Justice is Blind". Some believe that it is unfair for the healthy to subsidize the unhealthy.

Virtue Based Ethics

Based on the premise that our actions are universal, and that virtuous behavior includes perseverance, courage, integrity, compassion, humility, and justice. There is concern that people can be taken advantage of should they be too trusting.

3 Step Ethics Model

Is it legal? Is it balanced? How does it make me feel?

7 step decision making model

Determine the facts, define the precise ethical issue, identify major principles, rules, and values, specify the alternatives, compare values and alternatives, assess the consequences, make a decision

Dr. Bernard Lo's Clinical Model

1. Gather information.

2. Clarify the ethical issues.

3. Resolve the dilemma.

Patients should play an active role in decisions, as well as the entire healthcare team. This model is commonly used in a clinical setting.

Principle of Autonomy

People have the right to make decisions about their own life

Principle of Beneficence

We must not harm patients while we are trying to help them

Principle of Nonmalfeasance

means "First, do no harm."

Principle of Justice

Warns us that equals must be treated equally

Quality Assurance Committees

Issues Reviewed by a QA Committee:

-Patient complaints relating to confidentiality

-errors in dispensing medications

-errors in labeling lab specimens

-adverse reactions to treatments or meds

-inability to obtain venous blood on the first attempt

-safety and monitoring practices for labs

-infection control

Common Law

Also called case law, established from a court decision, may explain or interpret other sources of law. It evolves on a case-by-case basis.

Stare Decisis

let the decision stand

Tort

A civil injury, or wrongful act, that is committed against another person or property, resulting in harm, and is compensated by money damages

Intentional Torts

A person has been intentionally or deliberately injured by another:

-Assault (imminent apprehension of harm)

-Battery (bodily harm or unlawful touching)

-False Imprisonment (confining a patient)

-Defamation of Character (Slander or libel)\

-Fraud (attempts to deceive)

-Invasion of Privacy

Unintentional torts

-Negligence (failure to perform professional standard of care, such as a reasonable person would do)

-Malpractice (misconduct or demonstration of an unreasonable lack of skill)

Contract Law

Addresses a breach of contract, which can be implied or expressed

-Implied: agreement shown through inference

-Expressed: An agreement which clearly states all terms

Administrative law

A branch of public law, covers regulations that are set by government agencies:

-Licensing and supervision of prescribing, storing, and dispensing controlled substances

-regulations against homicide, infanticide, euthanasia, assault, and battery

-regulations against fraud

-Internal revenue service regulations that are healthcare related

Jurisdiction of Federal Courts:

-The dispute relates to a federal law or the U.S. constitution

-The U.S. government is a party involved in the suit

-Different states' citizens are involved in the case and involves more than $75,000

-The case involves a dispute between a US citizen and a foreign citizen and involves more than $75,000

-Dispute occurred in international waters

Probate court

handles cases involving the estates of the deceased

Subpoena

a written command from the court for a person or document to appear in court

Subpoena duces tecum

"under penalty, take with you". Requires a witness to appear in court with a certain document

National Board of Medical Examiners (NBME)

Examinations for licensure taken before the end of medical school. A state may offer endorsement for licensure gained through this exam.

Federal Licensing Examination (FLEX)

The official medical licensing exam.

U.S. Medical Licensing Examination (USMLE)

A single licensing examination introduced in 1992 which allows graduates from accredited med schools to practice medicine, given that they have:

-proof of completion of professional education

-proof of completion of residency program

-provide information of past criminal or addiction histories

-21 years old

-good moral character

-US citizenship

-residency in their state

Exceptions to requiring a valid state license to practice medicine:

-a physician employed by a federal medical facility like a veteran hospital (they must be licensed, but not necessarily in a particular state)

-out of state physician providing emergency medical care

-a physician who is waiting to become a qualified resident in a state in order to obtain a license

-a research physician who does not work with patients

-military physicians at military hospitals

Accreditation

voluntary process by which an educational program is evaluated and then recognized as having met certain predetermined standards of education

Joint Commission on Accreditation of Healthcare Organizations (JCAHO)

Established in 1952. Accredits all types of hospitals. Visits each hospital for an onsite inspection once every three years.

Commission on Accreditation of Allied Health Education Programs (CAAHEP)

Provides accreditation for programs such as medical assisting, emergency medical technicians, physician assistants, and respiratory therapists

Prudent Person Rule:

A physician must provide information that any reasonable or prudent person would expect, including:

-the diagnosis

-Potential risks of a treatment, including those which are unlikely

-expected benefits of the treatment

-possible alternative treatments

-the prognosis

-that an acceptable standard of care will be followed

-the costs, including the amount of expected pain

Medical Patient Rights Act

Passed in 1996. All patients have the right to their personal privacy respected and their medical information handled with confidentiality. PHI may not be passed on to a third party without a patient's consent, unless it has been subpoenaed

Discovery Rule

The statute of limitations begins when the problem is discovered or should have been discovered, which may be some time after the actual treatment

Guardian ad litem

A court appointed guardian to represent a minor in litigation

Good Samaritan Laws

A series of laws, varying in each state, designed to provide limited legal protection for citizens and some health care personnel when they are administering emergency care.

Respondeat Superior

"let the master answer". An employer is liable for the acts of the employee within the scope of the employment

Scope of practice

Refers to the activities a healthcare professional is allowed to perform as indicated in their license, certification, and training

Bonding

Insurance made with a bonding company that covers employees who handle financial statements, records, and cash. If that employee steals money, the physician can recover the loss up to the amount covered by the bond

Health Maintenance Organization (HMO)

Alternative means of health care in which people or their employers are charged a set amount and the HMO provides health care and covers hospital costs. It stresses preventative care and patient education.

Managed care

Offers medical care at a lower costs by decreasing the amount of unnecessary medical procedures. A gatekeeper is utilized in order to determine that all procedures and hospitalizations are necessary. A primary care physician can be a gatekeeper, as well as an insurance company.

Preferred Provider Organization (PPO)

A plan in which a patient uses a provider who is under contract with an insurer for an agreed fee in order to receive copayment from the insured. A fee for service program, not based on a fixed monthly fee.

Exclusive Provider Organization (EPO)

A type of managed care that combines the concepts of the HMO and PPO. The selection of providers is limited to a defined group, but the providers are paid on a fee for service basis. There is no insurance reimbursement if a nonemergency service is provided be a non-EPO provider.

Medicare

The federal program which provides healthcare coverage for persons aged 65 or older, disabled persons who are entitled to Social Security or Railroad Retirement benefits, and end stage renal patients of any age

Diagnostic Related Groups (DRGs)

1983 prospective payment system. Medicare patients were classified by principal diagnosis

into diagnostic related groups. Hospitals received a preset sum for treatment of each DRG as an incentive to keep costs down, however, this also discouraged the treatment of severely ill patients due to the high costs associated with their care.

Medicaid

A federal program implemented by individual states. the government pays for 57% of Medicaid expenditures. It provides financial assistance for insuring certain categories of the poor and indigent.

Health Care Quality Improvement Act (HCQIA) of 1986

Provides for peer review of physicians by other physicians. Provides protection from lawsuits that whistleblowers may face. Sets up a National Practitioner Data Bank (NPDB).

National Practitioner Data Bank (NPDB)

Collects information about physicians' medical malpractice losses and settlements, investigations into licensure, and other damaging professional conduct

Solo Practice

A physician practices alone. Many are reluctant to enter into this because of the large debt they incur from education and the high cost of operating an office.

Sole proprietorship

A physician may employ other physicians and pay them a salary, but they retain all profits from the practice. This practice may involve long working hours and is falling out of practice due to increasing expenses and lack of another physician to share in the same workload.

Partnership

A legal agreement to share in the business operation of a medical practice. Can increase earning power at the risk of personality conflicts.

Associate Practice

A medical management system in which two or more physicians share office space and employees but practice individually.

Group Practice

a medical management system in which three or more licensed physicians share the collective income, expenses, facilities, equipment, records, and personnel for the business

Professional Corporation

managed by a board of directors, benefits to employees, can be sued without damage to employee individual assets. Income may not be as great as other practices.

Fee Splitting

A physician accepting payment from another physician solely for the referral of a patient, which is considered both unethical and illegal

Healthcare employee stats:

-9 million total

-600,000 physicians

+150,000 of which practice primary patient care (family medicine, internal medicine, obstetrics, and pediatrics)

-35,000 doctors of osteopathy

-150,000 dentists

American College of Surgeons

Confers a fellowship degree, making candidates fellows of the American College of Surgeons (FACS)

American College of Physicians

Offers fellowship, candidates become a Fellow of the American College of Physicians (FACP)

Certification

Voluntary credentialing process usually offered by a private organization

The American Association of Medical Assistants (AAMA)

Founded in 1956, responsible for certifying medical assistants

American Medical Technologists (AMT)

association which provides registration and testing for medical assistants, medical technologists, and phlebotomists. Also a nonprofit certifying body which can confer Registered Medical Assistant (RMA) certification

AMT Institution for Education (AMTIE)

continuing education and recording system for medical technologists

Accrediting Bureau of Health Education Schools (ABHES)

voluntary accreditation which requires that educational facilities maintain particular standards which usually include an internship

The Summary of Opinions of the Council on Ethical and Judicial Affairs of the AMA (2008-2009)

A physician has the right to select which patients to treat, but cannot abandon a patient

Ethical considerations for treating AIDS patients:

-persuade the patient to inform partners

-notify the authorities when there is a suspicion that the patient will not inform others

-as a last resort, personally notify the partners

Living Will (advanced directive)

document that a person drafts before becoming incompetent and unable to make healthcare decisions

Durable Power of Attorney for healthcare

empowers a proxy to make healthcare decisions for an incompetent patient, which goes into effect after the person becomes incompetent. Only applies to healthcare decisions

Uniform Anatomical Gift Act

Allows persons of 18+ years and of sound mind to donate their organs for transplantation or medical research

do not resuscitate (DNR) order

Indicates that a person does not wish to be resuscitated if breathing stops

Patient Self Determination Act (PSDA)

Passed in 1991, supporting a person's right to self determination before becoming incompetent. An example of legislation supporting advanced directives.

in loco parentis

in place of a parent, indicating a person who may give consent for care of a child when the parents are not present or able to give consent

parens patriae authority

occurs when the state takes responsibility from the parents for the care and custody of minors under the age of 18

The Doctrine of Informed Consent:

Requires the physician to explain the following in understandable language:

-The patient's diagnosis

-the nature and purpose of a proposed treatment

-advantages and risks of a treatment

-alternative treatments available

-potential outcomes

-what may happen if the patient refuses the treatment

Procedures in which informed consent forms should be signed include:

-minor invasive surgery

-organ donation

-radiological therapy

-electroconvulsive therapy

-experimental procedures

-chemotherapy

-any procedure with more than a slight risk of harm to the patient

Exceptions to Consent:

-a physician need not inform a patient about commonly known risks

-a physician believes the disclosure of risks may be detrimental to the patient

-the patient asks that risks not be disclosed

-physician is not required to restore patients to original health

-physicians may not elicit a cure for every patient

-physicians cannot guarantee success for every patient

Malfeasance

the performance of a totally wrongful and unlawful act

Misfeasance

The performance of a lawful act in an illegal or improper manner

Nonfeasance

The failure to act when one should

The 4 Ds of Negligence

To obtain a judgement for negligence against a physician, one must show all four Ds:

-Duty: the patient must prove that there was an established patient-physician relationship

-Dereliction of Duty: the physician's performance did not comply with the acceptable standard of care

-Direct or Proximate Cause: a continuous or closely related relationship between the physician's actions and injury

-Damages: Injuries caused by the defendant

res ipsa loquitur

the thing speaks for itself, neglect is so obvious that it doesn't need further explanation. In this case, the burden of proof falls on the defendant rather than the plaintiff

Office of the Inspector General

Protects programs under the Department of Health and Human Services (HHS) from fraudulent activities

The Office of Counsel to the Inspector General:

-provides legal services to the OIG

-represents to OIG in civil cases tried under the False Claims Act

-Imposes money penalties on healthcare providers found guilty of fraud

-issues fraud alerts

Contributory Negligence

The plaintiff contributed to the cause of the injury and may be barred from recovering damages

Comparative Negligence

The plaintiff contributed to the injury, and may recover damages based on the amount of the defendant's fault

Borrowed Servant Doctrine

a special application of respondeat superior in which an employer lends an employee to someone else.

Res judicata

"the thing has been decided". A plaintiff cannot bring the same lawsuit against the same defendant

Federal Rules of Evidence

allow medical records into courts as evidence under the Uniform Business Records Act

General Guidelines to Prevent Malpractice:

-act within your scope of practice

-ensure that staff understand what practices are unlawful

-provide training on what is meant by standard of care and professional conduct

-never promise a cure or recovery

-treat all patients with courtesy and respect

-avoid having patients spend more than 20 minutes in the waiting room

-identify patients before beginning treatment

-avoid over the phone diagnosis

-provide CME

-do not criticize employees in public areas

Information on a death certificate:

-the date and time of death

-the cause of death

-how long the deceased person was treated before dying

-the presence of absence of pregnancy

-if an autopsy took place

Coroner

Holds an inquest if the death is from an unknown or violent cause

The Communicable Disease Report Should include:

-name, address, age, and occupation of the patient

-name of disease

-date of the onset of the disease

-name of person issuing the report

Diseases which require reports:

-tuberculosis

-rubeola

-rubella

-tetanus

-diphtheria

-cholera

-poliomyelitis

-AIDS

-meningococcal meningitis

-rheumatic fever

-STDs

National Childhood Vaccine Injury Act of 1986

requires the physician or administrator all vaccine administrations and adverse effects

The Child Abuse Prevention and Treatment Act

1974, requires reporting of all child abuse cases

Older Americans Act

A 1987 act which defines elder abuse as physical abuse, neglect, exploitation, and abandonment of adults 60 years and older

Food and Drug Administration (FDA)

an agency within the department of health and human services, ultimately enforcing drug sales and distribution. Has the responsibility of categorizing the tests run in laboratories and distinguishing which can be waived under CLIA regulations.

Drug Enforcement Administration (DEA)

regulates addictive drugs using the Controlled Substances Act of 1970

The Controlled Substances Act

Enacted in 1970, regulates the manufacture and distribution of drugs which can cause dependence, and places controlled drugs into five schedules

The Bureau of Narcotics and Dangerous Drugs (BNDD)

an agency of the federal government responsible for enforcing laws covering statutes of addictive drugs.