the practical application of moral standards to the conduct of individuals involved in organizations that are meant to benefit the patient, such as medical ethics
a branch of applied ethics, is a field resulting from modern medical advances and research
an excessive inclination to sue
rules or actions prescribed by an authority such as the federal government and the court system that have a binding legal force
medical practice acts
laws established in all 50 states that define the practice of medicine as well as requirements and methods for licensure in a particular state
the decision of the court case acts as a model for any future cases in which the facts are the same
branch of philosophy related to morals, moral principles, and moral judgments
the quality of being virtuous or practicing the right conduct
lacking or indifferent to moral standards
concerns questions related specifically to the practice of medicine
an ethical theory based on the principle of what is the greatest good for the greatest number of people
justifies the means of achieving a goal
a person who is impoverished and without funds
a natural rights ethical theory, places the primary emphasis on a person’s individual rights
based on absolute moral rules; focuses on performing one’s duty to various people and institutions such as parents, employers, employees, and customers (patients)
based on an important moral restraint called “the veil of ignorance”; fair distribution of benefits and burdens
based on the belief that we have a duty or responsibility to others; an emphasis on persons and not necessarily on the decisions or principles that are involved
loyalty and faithfulness to others
sanctity of life
the sacredness of human life
a respect for those whose opinions, practices, race, religion, and nationality differ from our own
the unwavering adherence to one’s principles
the ability to understand the feelings of others without actually experiencing their pain or distress
feeling sorry for or pitying someone else
the ability to have a gentle, caring attitude toward patients and fellow employees
the entitlement of employees of the government and public companies to have certain procedures followed when they believe their rights are in jeopardy; the Fourteenth and Fifth Amendments provide for due process
sexual harassment or gender harassment
unwelcome sexual advances or requests for sexual favors as defined in the Equal Employment Opportunity Commission guidelines, which are part of the Title VII of the Amended Civil Rights Act of 1964
known as pay equity, is a theory that extends equal pay requirements to all persons who are doing equal work
principle of autonomy
the principle that people have the right to make decisions about their own life; includes the concept of “informed consent”, whereas consent is granted by a person after the patient has received knowledge and understanding of potential risks and benefits
principle of beneficence
the principle of doing good
principle of nonmalfeasance
means “First, do no harm.”
principle of justice
warns us that equals must be treated equally
specialists in the field of bioethics, give thought to ethical concerns that often examine the more abstract dimensions of ethical issues and dilemmas
quality assurance (QA)
gathering and evaluating information about the services provided, as well as the results achieved, and comparing this information with an accepted standard
standards of professional behavior that physicians practice in their relationship and conduct with patients and other physicians
1 Large Government- Federal Government
Many smaller local governments
President and his cabinet
Has Veto power
Judges- Supreme Court (Justices)
Congress- Senate- House of Representatives
2/3 majority vote can override a veto
Burden of Proof
Plaintiff has BOP in Civil cases
State/Prosecutor has BOP in Criminal cases
BOP is proving propondence of evidence in civil
beyond a reasonable doubt in criminal
(Statutes) Laws written by the legislative branch
(Regulations) Laws written by agencies
Examples of intentional torts
Assault, Battery, False Imprisonment
Actual unconsented physical contact
Threat of bodily harm, placing someone in apprehension of imminent harm
Class Action Lawsuit
A lawsuit filed by one or more people on behalf of a larger group of people who are all affected by the same situation
Set up our system of government
Bill Of Rights- Freedoms- Prevents governments from interferring with our individual rights
Defamation Of Character
Harm to a person’s reputation
False statements about a person
Taking money of or property that has been entrusted to you
An agreement that clearly states all the terms
Decieving another person, usually for personal gain
Understood through actions
A written command from the court for a person to appear in court
“Let the decision stand”
When a person has been intentionally or deliberately injured by another
Negligence- Medical Malpractice
Duty of care- Fail to exercise reasonable care that results in harm
Civil injury or wrongful act that results in harm
Confining someone against their will
Invasion Of Privacy
Unauthorized publication of private information
Agreement between two or more people
Subpoena “Duces Tecum”
A court order requiring a witness to appear in court and to bring certain records/documents
Rules or laws made by agencies
Laws enacted by state and federal legislatures
A person on group of people suing another person or group; the person who instigates the lawsuit
Person or group of people sued civilly or prosecuted criminally in a court of law
Set up to protect the public from the handful acts of others
Also known as Common Law
Based on decisions made by judges
Division of law that includes enforceable promises and agreements between two or more persons to do or not to do a particular thing
Also known as Case Law
Based on decisions made by judges
Relationships between individuals or between individuals and the government, which are not criminal
Branch of law that covers regulations set by government agencies
Breach Of Contract
The failure, without legal excuse, to perform any promise or to carry out any of the terms of an agreement; failure to perform a contractual duty
Neglect of an understanding between two parties; failing to perform a legal duty
Beyond A Reasonable Doubt
Evidence that is almost an absolute certainty that a person did commit a crime
Checks And Balances
Separation between the three branches
Preponderance Of Evidence
Evidence showing that more likely than not the incident occured
a voluntary process in which an agency is requested to officially review healthcare institutions, such as hospitals, nursing homes, and educational institutions, to determine compliance.
a special type of insurance that covers employees who handle financial statements, records, and cash.
refers to keeping private all information about a person (patient) and not disclosing it to a third party without the patient’s written consent.
rule legal theory that provides that the statute of limitations begins to run at the time the injury is discovered or when the patient should have known of the injury.
an approval or sanction.A state may grant a license by endorsement to applicants who have successfully passed the NBME exam.
Good Samaritan laws
state laws that help protect healthcare professionals from liability while giving emergency care to accident victims.
court-appointed guardian to represent a minor or unborn child in litigation.
a means of documenting problem areas within a hospital or other medical facility.
Joint Commission on Accreditation of Healthcare Organizations (JCAHO)
an agency that oversees accreditation standards for:
• all types of hospitals (medical, psychiatric, long-term care, etc.)
• managed care oranizations (like HMOs)
• VNAs (visiting nurse associations)
• clinical laboratores
Prudent person rule
also called the responsible person standard, means the healthcare professional must provide the information that a prudent, reasonable person would want before making a decision about treatment or refusal of treatment.
This would include:
• the diagnosis
• the risks and potential consequences of treatment
• the expected benefits of the treatment or procedure
• potential alternative treatments
• prognosis if no treatment is received
• that an acceptable standard of care is followed
• the costs, including the amount of expected pain
the cooperation of one state in granting a license to practice medicine to a physician already licensed in another state. Reciprocity can be applied to other licensed professionals, such as nurses and pharmacists.
Latin phrase meaning “let the master answer” means the employer is responsible for the actions of the employee.
take away, as in revoke a license.
a practice to minimize the incidence of problem behavior that might result in injury to the patient and liability for the organization.
the activities a healthcare professional is allowed to perform as indicated in their license, certification, and/or training.
the ordinary skill and care that medical practitioners use and that is commonly used by other medical practitioners in the same locality when caring for patients; what another medical professional would consider appropriate care in similar circumstances.
Statute of limitations
the period of time that a patient has to file a lawsuit; typically 1 to 3 years. The time period begins when the problem is discovered or should have been discovered.
also known as running of the statute of limitations, means the time has expired.
List the four basic characteristics of state medical practice acts.
• Establish the baseline for the practice of medicine in that state.
• Determine the prerequisites for licensure.
• Forbid the practice of medicine without a license.
• Specify the conditions for license renewal, suspension, and revocation.
Describe the three methods by which a state grants a license to practice medicine.
• Examination—Each state offers its own examination for licensure.
• Endorsement—This is an approval or sanction granting a license by endorsement
to applicants who have successfully passed the National Board of Medical
• Reciprocity—A license to practice medicine may be granted by a state that
accepts a medical license granted by another state.
Discuss conduct that may result in a physician’s loss of license to practice medicine.
Conduct that could result in the loss of a physician’s license includes Medicare/
Medicaid fraud, rape, murder, larceny, narcotics conviction, and the inappropriate
use of drugs and alcohol.
Identify the difference between licensure and certification.
A license is granted by a state or federal entity. This provides the legal right
for a professional, such as a physician, to practice.
Certification is granted by a certification board and means that a person has
met the special requirements, such as additional education and training,
of the certifying board.
Discuss what the term standard of care means for a physician and what it means for someone in your profession (or your planned profession).
Standard of care, as it relates to the physician, is the ordinary skill and care that medical practitioners use and that is commonly used by other medical practitioners in the same locality when caring for patients. It is the care that another professional would find appropriate in similar circumstances.
Describe the importance of the discovery rule as it relates to the statute of limitations.
The discovery rule is the legal theory that provides that the statute of limitations
begins to run at the time the injury is discovered or when the patient should
have known of the injury.
Discuss the importance of the phrase respondeat superior as it relates to the physician.
This translates to “let the master answer.” It means that the employer (physician)
is responsible for the actions of the employee.
p. 57 – Every state has a board set up to handle issues relating to physician registration.
p. 60 – If a physician continues to practice medicine without renewal of his or her license, under the law it is considered practicing medicine without a license.
p. 61 – The term “reasonable” is a broad, flexible word to make sure the decision is based on the facts of a particular situation rather than on abstract legal principles. It can mean fair, rational, or moderate. Reasonable care has been defined as “that degree of care a person of ordinary prudence would exercise in similar circumstances”.
p. 63 – Do not discuss anything relating to a patient within earshot of others.
p. 63 – The statute of limitations is a state law that varies by state.
p. 64 – The Good Samaritan laws do not protect physicians or their employees from liability while practicing their profession in their work environment. The laws are meant to encourage medical professionals to assist with emergencies outside of the work setting. Always check the coverage of the Good Samaritan Law in your own state.
p. 65 – Even though the doctrine of respondeat superior mainly refers to the employer, in all states both the physician and the employee may be liable.
p. 66 – Healthcare workers have a duty to be assertive and question those orders that they believe are erroneous or appear to be harmful to the patient. They also have a duty to refuse to carry out orders that violate their own practice acts.
p. 67 – All employees must understand that there are limits to their authority when it comes to healthcare decisions. The ultimate decision always rests with the physician, provided it does not violate their professional practice.
p. 68 – Everyone in a healthcare institution – not just the risk manager – is responsible for risk management.
Medical Practice Acts
Statues that govern the practice of medicine in that state. They establish:
• requirements for licensure
• duties of the licensed physician
• grounds on which the license may be revoked
• reports that must be made to the government
• define penalties for practicing without a license
Federal Licensing Examination
The official U.S. medical licensing exam.
National Board of Medical Examiners
U.S. Medical Licensing Examination
Periodic (annual or biannual) renewal of a medical license. Requirements include:
• continuing medical education, measured in CME units (typically 75 hours in a 3 year period). This can be done through workshops, courses, seminars, self-instruction modules, teaching, reading approved medical literature.
Commission on Accreditation of Allied Health Education Programs
provides accreditation for programs such as medical assisting, emergency medical technicians (EMTs), physician assistants, and respiratory therapists, among others.
Employee’s Duty to Carry Out Orders
Healthcare workers have a duty to be assertive and question those orders that they believe are erroneous or appear to be harmful to the patient. They also have a duty to refuse to carry out orders that violate their own practice acts.
Employer’s Duty to Employees
Medical Patient Rights Act
Law passed by Congress that says all patients have the right to have their personal privacy respected and their medical records handled with confidentiality.
• no information can be shared without the patient’s consent
• no information can be given over the phone without consent
• no records an be given to another person or physician without the patient’s written permission (unless subpoenaed).
• information should be shared only on a need-to-know basis
Medical Licensure Exams
NBME – National Board of Medical Examiners
FLEX – Federal Licensing Examination
USMLE – U.S. Medical Licensing Examination
Exceptions to State Medical License Requirement
• physician employed by a federal medical facility (must be licensed but not necessarily by the state they are practicing in)
• a out-of-state physician providing emergency care
• physician waiting to qualify for residency
• research physician who does not practice patient-based medicine
• military physicians at military hospitals
A license is granted by a state or federal entity. This provides the legal right for a professional, such as a physician, to practice.
Certification is granted by a certification board and means that a person has met the special requirements, such as additional education and training,of the certifying board.
administer a drug
To introduce a drug into the body of a client
One who appeals a court decision to a higher court
The procedure of calling someone before a court to answer a charge
Court action between private parties, corporations, government bodies, or other organizations. Compensation is usually monetary. Recovery of private rights is sought.
Summary and last statements made by opposing attorneys at a hearing or trial
Controlled Substances Act
Federal law regulating the administration, dispensing, and prescription of particular substances that are categorized in five schedules.
court of appeals
Court that reviews decisions made by a lower court; may reverse, remand, modify, or affirm lower court decision.
An order issued only by a judge to appear or to request certain records. The release of any records requested in a court order does not require the client’s permission.
Court action brought by the state against individual(s) or groups of people accused of committing a crime; punishment usually imprisonment or a fine; recovery of rights of society.
Examination of a witness by an opposing attorney at a hearing or trial.
The person or group accused in a court action.
A written record of oral testimony made before a public officer for use in a lawsuit.
Examination of a witness by the attorney calling the witness at a hearing or trial.
dispense a drug
To deliver controlled substances in a bottle, box, or some other container to the client. Under the Controlled Substances Act, the definition also includes the administering of controlled substances.
examination of witness
Questioning of a witness by attorneys during a court action.
expert witness (medical)
Person trained in medicine who can testify in a court of law as to what the professional standard of care is in the same or similar communities.
A serious crime such as murder, larceny, assault, or rape. The punishment is usually severe.
higher (superior) court
The court to which appeals of trial court decisions can be made; a court with broader judicial authority than a lower or inferior court.
A public official who directs court proceedings, instructs the jury on the law governing the case, and pronounces sentence.
Six to 12 individuals, usually randomly selected, who are administered an oath and serve in court proceedings to reach a fair verdict on the basis of the evidence presented.
Rule or regulation that is advisable or obligatory to observe.
A lawsuit; a contest in court.
lower (inferior) court
Usually the court in which a case is first presented to the trial court; a court with limited judicial authority.
Type of crime less serious than a felony.
Statements made by opposing attorneys at the beginning of a court action to outline what they hope to establish in the trial.
The person or group initiating the action in litigation.
prescribe a drug
To issue a drug order for a client.
probate (estate) court
State court that handles wills and settles estates.
Imposition of punishment in a criminal proceeding.
small claims court
Special court intended to simplify and expedite the handling of small claims or debts.
An order to appear in court under penalty for failure to do so.
subpoena duces tecum
A court order requiring a witness to appear and bring certain records or tangible items to a trial or deposition.
An order, in a civil case, from the court directing the sheriff or other appropriate official to notify the defendant where and when to appear.
Findings or decision of a jury.
A physician shall be dedicated to providing competent medical service with compassion and respect for human dignity.
A physician shall deal honestly with patients and colleagues, and strive to expose those physicians deficient in character or competence, or who engage in fraud or deception
Responsibility to Society
A physician shall respect the law and recognize a responsibility to seek changes in those requirements that are contrary to the best interests of the patient.
A physician shall respect the rights of patients, of colleagues, and of other health professionals, and shall safeguard patient confidence within the constraints of the law.
A physician shall continue to study, apply, and advance scientific knowledge, make relevant information available to patients, colleagues, and the public, obtain consultation, and use the talents of other health professionals as needed.
Freedom of Choice
A physician shall, in the provision of appropriate health care, except in emergencies, be free to choose whom to serve, with whom to associate, and the environment in which to provide service.
Responsibility to Improved Community
A physician shall recognize a responsibility to participate in activities contributing to an improved community.
Responsiblity to Patient
Responsiblity to patient is paramount
Patient Access to Medical Care
Must support access to medical care for all people.
Gifts to physicians from medical companies can be accetped only if they relate to the physician’s medical practice. However, drug samples from pharmaceutical companies can be accepted for patient use.
Conflict of interest
Physicians should not place their own financial interests above the patient’s welfare.
Historically, there is an unwritten practice among many physicians taht they would not charge each toher for professional services. However, this practice has lost favor because many physicians are concerned about the lack of documentation when seeing a fellow physician free of charge.
Reporting Unethical Conduct
A physician should report any unethical conduct by other physicians.
Physicians should recommened that patients seek a second opinion whenever necessary.
It is unethical for the physician to engage in sexual conduct with a patient during the physician-patient relationship.
Treating Family Members
Physicians should not treat members of their families except in an emergency.
When a private hospital emergency room sends an indigent patient to a public hospital emergency room.
The Comprehensive Omnibus Budget Reconciliation Act (COBRA)
contains an amendment that prohibits “dumping” patients from on facility to another. It is now a federal offense to do this. This amendment does not mandate treatment, but it does require a hospital to stabilize a patient during an emergency situation.
withdrawing emdical care from a patient without providing sufficient notice to the patient. Considered to be a civil wrong or tort and condsidered to be a breach of contract and even negligence.
Certified Mail – Abandonment
Sending a letter by certified mail is the best method physicians can use to protect themseleves from a charge of abandoment when they have to sever a relationship with a patient.
Against Medical Advice (AMA)
when a noncompliant patient leaves a hospital without physician’s permission
Acquired Immunodeficiency Syndrome (AIDS)
is a diease resulting in infections that occur as a result of exposure to the human immunodeficiency virus (HIV), which causes the immune system to break down. First documented in the US in 1980.
Americans with Disabilites Act (ADA)
A federal law, protects HIV and AIDS patients from discrimination.
Prediction for the course of their disease
Medical Patients Rights Act
provides that all patients have the right to have their personal privacy respected and their medical records handled with confidentiality.
refers to confidential information that has been told to a physician (or attorney) by the patient.
Patient’s Bill of Rights
descrbies the physician-patient relationship
Self-Determination Documents or Advance Directives
States the patinet’s intentions for healthcare-related decisions and in some cases name another person as proxy to make decisons for the patient.
Proxy or Agent
a person who acts on behalf of another person
is the written authorization given by a person so that a second person can act for him or her.
is a written statement in which people state the type and amount of care they wish to receive during a terminal illness and as death approaches.
Document that a person drafts before becoming incompetent orunable to make heathcare decisions.
Durable Power of Attorney for Healthcare
A legal doucment that empowers another person (proxy) to make healthcare decisions for an incompetent patient. It goes into effect after the person beomces incompetent and only pertains to healthcare decisons.
Uniform Anatomical Gift Act
All states have some form of this law. It allows persons 18 years or older and of sound mind to make a gift of any part of their body for purposes of medical research or transplantation.
Do not Resuscitate (DNR) Order
This is an order placed into a person’s medical chart or medical record. It indicates taht the person does not wish to be resuscitated if breathing stops.
Modified Rights of Terminally Ill Act
which states that the person must be terminally ill and/or in a state of permanent unconsciousness. The patient must be in a state that is irreversible, untreatable, and incurable with the prospect of imminent death.
Patient Self-Determination Act (PSDA)
was passed in 1991 and states that congress has stongly supported a person’s right to self-determination before beoming incompetent.
is a person who has not reached the age of maturity, which in most states is 18.
In loco parentis
consent of the parents or someone standing in for the parents
principle of parens patriae authority
occurs when the state takes responsiblity from the parents for the care and custody of minors under the age of 18.
a person judged to be mature enought to understand teh physician’s instructions. Such a minor may seek medical care for treatment of drug or alcohol abuse, contraception, venereal disease, and pregnancy.
a person between the ages of 15 and 18 who is either married, in the military, or self-supporting and no longer lives under teh care of a parent. Parental consent for medical care is not required. Proof of emancipation should be included in the medical record.
is the voluntary agreement that a patient gives to allow a medically trained person the permission to touch, examine, and perform a treatment.
Informed or Expressed Consent
means taht the patient agrees to the proposed course of treatment after having been told about the possible consequences of having or not having certain procedures and treatments. The patients’s signature on the consent form indicates that the patient understands the limits or risks involved in the pending treatment or surgery as explained by the physician.
allows the defendant (usually physician or hospital) to present evidence that the patient’s condition was the result of factors other than the defendant’s negligence.
• Denial (the most frequently used defense)
• Assumption of risk
• Contributory negligence
• Comparative negligence
• Borrowed servant
• Statute of limitations
• Good Samaritan laws
Alternative dispute resolution (ADR)
methods for resolving a civil dispute that do not involve going to court.
Using arbitration, mediation or a combination (med-arb) for deciding a civil case can same time and money.
submitting a dispute for resolution to a person other than a judge.
this can be time consuming because both parties must agree on the choice of arbitrator. Then both parties must agree to abide by the arbitrator’s decision.
a person chosen to decide a disagreement between two parties.
Assumption of risk
a legal defense that prevents a plaintiff from recovering damages if the plaintiff voluntarily accepts a risk associated with the activity.
Patients should be asked to sign an authorization for all procedures indicating that they understand the risks involved, accept those risks, and give their consent for treatment.
Borrowed servant doctrine
a special application of respondeat superior in which an employer lends an employee to someone else.
The employer is not liable for any negligence caused by the employee while in the service of the temporary employer.
In some states, where there is no cap, malpractice insurance have risen to a point where some physicians have had to leave their practices.
liability insurance that covers the insured party for only the claims made during the time period the policy is in effect (or policy year).
It is important with this type of insurance to file reports in a timely manner, especially by the time of the policy’s year end.
a defense, similar to contributory negligence, that the plaintiff’s own negligence helped cause the injury; not a complete bar to recovery of damages but only damages based on the amount of the plaintiff’s fault.
an amount of money awarded by the court to make up for loss of income or emotional pain and suffering.
Payment for the actual loss of income, emotional pain and suffering, or injury suffered. The losses are past, current, and future and include lost wages and profits.
conduct on the part of the plaintiff that is a contributing cause of injuries; a complete bar to recovery of damages.
any injuries caused by the defendant; usually a monetary award is given as compensation.
Patients seek recovery, or compensation, for a variety of damages:
• Permanent physical disability
• Permanent mental disability
• Loss of enjoyment of life
• Personal injuries
• Past and future loss of earnings
• Medical and hospital expenses
• Pain and suffering
ordering more tests and procedures and referring to specialists more often than necessary in order to protect oneself from a lawsuit.
The result is patients have to undergo additional tests and procedures and the cost of healthcare increases. The over use of specialist can negatively impact the relationship with the PCP.
Defensive medicine becomes problematic if a physician becomes reluctant to attempt more risky, but potentially effective procedure for fear of a lawsuit.
Studies show that physicians with good bedside manner (talking unhurriedly, sitting on the bedside, holding the patient’s hand) were much less likely to be sued (regardless of skill). This extends to all healthcare professionals and is why physicians hire employees who project a warm and caring attitude toward
neglect, as in neglect of duty.
(or proximate cause)
p. 136 & 137
the continuous sequence of events, unbroken by any intervening cause, that produces an injury and without which the injury would not have occurred.
Proximate cause means there were no intervening forces between the defendant’s action(s) and the plaintiff’s injury — hence, a cause-and-effect relationship.
Proximate cause refers to the last negligent act that contributed to a patient’s injury, without which the injury would not have resulted.
obligation or responsibility.
doing an act or performing a duty.
Federal Rules of Evidence
rules that govern the admissibility of evidence into federal court.
the deliberate concealment of the facts from another person for unlawful or unfair gain.
Illegal billing, referral kickbacks, dishonesty when conducting medical research, embezzlement, and the illegal sale of drugs are all forms of fraud.
Frequently cited areas of medical related fraud are on p. 141.
the legal relationship formed between two people when one person agrees to perform work for another person. (This does not apply to pharmacists since they are not hired by the physicians.)
In order to protect the physician/employer from liability for negligence under the doctrine of respondeat superior, the healthcare professional should:
• Have a written job description that clearly defines the responsibilities, duties and skills necessary for the job.
• Use extreme care when performing his or her job
• Carry out only those procedures for which he or she is trained
• Be honest about any errors or inability to perform a procedure
legal responsibility for one’s own actions.
performing an illegal act.
Medical personnel must be especially aware of malfeasance when they offer advice such as “Try giving your child aspirin to bring down the fever.”
professional misconduct or demonstration of an unreasonable lack of skill with the result of injury, loss, or damage to the patient.
A physician is held to a different but not higher standard of care than a nurse, medical assistant, physician assistant, or phlebotomist.
Medication errors are one of the leading types of medical errors.
using the opinion of a third party to resolve a civil dispute in a nonbinding decision.
The mediator lists to both sides of the dispute and assists the parties in finding a solution.
the improper performance of an otherwise proper or lawful act.
Occurs when poor technique is used; such as when a phlebotomist performs veinipuncture and the patient suffers nerve damage.
an unintentional action that occurs when a person either performs or fails to perform an action that a “reasonable person” would or would not have committed in a similar situation.
a slight or token payment awarded by the court.
the failure to perform an action when it is necessary.
An example would be when a patient collapses in the office and a nurse trained in CPR fails to administer it.
also called claims-incurred insurance, liability insurance that covers the insured party for all injuries and incidents that occurred while the policy was in effect (policy year), regardless of when they are reported to the insurer or when the claim is made.
With this type of insurance it is important to clearly documetn when an event took place.
the injury was closely (proximately) related to the defendant’s negligence.
Punitive damages or exemplary damages
also called exemplary damages, monetary award by a court to a person who has been harmed in an especially malicious and willful way; meant to punish the offender.
Latin phrase meaning “the thing has been decided.”
additional component to an insurance policy.
the act of determining the outcome of a case outside a courtroom; settling a case is not an indication of legal wrongdoing. It usually means the defendant believes that he or she cannot with the lawsuit. (Poor charting techniques are sometimes the cause.)
p. 133 – All healthcare workers are responsible for their actions even though the doctrine of respondent superior states that an employer is also liable for injury to a patient.
p. 134 – When a person is injured they are sue under tort law (“a wrongful act against another person”). The unintentional tort of negligence is the most often cause of lawsuits for healthcare professionals.
p. 134 – Not everyone will perform reasonable skill in the same way. However, unreasonable lack of skill is unacceptable
because it shows lack of skill or carelessness.
p. 135 – The best solution is to avoid errors is to always double-check all orders and healthcare decisions that physicians and other healthcare professionals make. Electronic prescriptions has eliminated many medication errors. Most important, never perform a procedure for which you are not trained.
p. 135 – You can be sued even if you are right. Patients can be injured though no fault of the medical personnel.
p. 136 – The determination of duty in the court room is the responsibility of the judge, not the jury.
p. 137 – Proximate cause refers to the last negligent act that contributed to a patient’s injury, without which the injury would not have resulted.
p. 137 – To have preponderance of evidence to find in favor of the plaintiff, the jury believes that it is at least 51 percent likely that the defendant caused the injury.
p. 141 – Filing a false claim for programs such as Medicare or Medicaid is a federal crime. The employee’s physician could be severely fined and even lose his or her license for this type of fraudulent act.
p. 142 – Every person has the right to say “no” when asked to perform an activity that is unethical, illegal, or against his or her own value system.
p. 143 – It is easier to prevent negligence that to defend it.
p. 144 – The physician is solely responsible for explaining the risks of treatment or procedure. If a they delegate this function to a nurse, medical assistant, or physician assistant, the physician still retains overall responsibility.
p. 144 – Instructions given to the patient should always be noted in the patient’s record.
p. 145 – Healthcare professionals should have an understanding of what is right and wrong under the law. Arguing that a negligent act was unintentional is not a defense, nor is ignorance of the law.
p. 146 – Medical personnel must listen to and respect the patient’s wishes.
p. 146 – Every staff remember must take responsibility for reporting and correcting defects (to the physical condition of the premises) that could cause injury.
p. 147 – Be alert for indications of drug use among coworkers. Reporting abuse is necessary in order to get help for the abuser and to protect patients and the reputation of the facility.
p. 147 – A comment made to a patient such as “I’m sure you will be fine.” could be taken as a verbal contract.
p. 148 – Never completely obliterate any notation on a chart. If a note is placed in the wrong chart, cross through the notation with one line and write “Incorrect Chart” and you name.
p. 148 – Never alter a medical record
p. 150 – There is no law that states, ” If you didn’t document it, you didn’t do it,” however, it is difficult to defend a practice that is not documented.
p. 152 – Medical assistants can be named and prosecuted in lawsuits.
p. 152 – The public often assumes anyone in a white uniform is a nurse. Unless they are an R.N. the healthcare professional must correct the patient.
p. 154 – Healthcare professionals must only practice within the scope of their training. There are times when a healthcare professional must refuse to perform a task.
The Tort of Negligence
Both actions and inactions (omissions) can be considered negligence.
Professional liability malpractice claims
The Four Ds of Negligence
In order to obtain a judgement of negligence against a physician (defendant), the patient (plaintiff) must be able to show all four of the Ds.
Duty – takes place when there is an obligation established between the physician and the patient
Dereliction of duty – the physician or healthcare provider failed to provide a correct standard of care to the patient and therefore, has not met the duty.
Direct or proximate cause – the dereliction or breach of duty was the direct cause of the patient’s injury
Damages – injuries caused by the defendant for which compensation (financial or otherwise) is due.
Preponderance of Evidence
One side of a case must demonstrate a greater weight of evidence than the other side.
The plaintiff must prove that it is more likely than not that the defendant, (physician), has caused the injury.
The burden of proof is on the plaintiff.
Res Ipsa Loquitur
(also called Res ipsa loquitur or RIL)
This doctrine means “the thing speaks for itself” and refers to situations where the breach of duty is so obvious that it doesn’t need further explanation.
Under res ipsa, an exception to the burden of proof rule occurs, and the burden of proof now falls to the defendant. A judge decides if a case can be tried under ris ipsa; to do so three conditions must be present:
1. The injury could not have occurred without negligence.
2. The defendant had total and direct control over the cause of the injury, and the duty was within the scope of the duty owed to the patient or injured party.
3. The patient did not, and could not, contribute to the cause of injury.
In order to have a civil malpractice lawsuit, the plaintiff (patient) must show that:
1. A relationship had been established
2. The relationship established a duty of the physician to the patient.
3. The duty required the physician to perform at a particular standard of care.
4. The duty was breached by the physician.
5. The patient received an injury as a result of the physician’s breach of duty.
6. The physician’s breach of duty was the proximate cause of injury to the patient.
Types of Compensatory Damages
• Special compensatory or exemplary damages
Special compensatory or exemplary damages
Refers to a monetary award to compensate the patient for losses that were not directly cased by the negligence. (Such as PT needed for atrophy that was a result of the injury.) Non-economic reasons include disfigurement, disability, loss of consortium.
If a patient’s death has been caused by the physician’s negligence, the deceased person’s dependents and heirs may sue for wrongful death.
A plaintiff in a wrongful-death suit does not have to prove that he or she was completely dependent on the deceased person for support.
The plaintiff must prove that the defendant’s actions were the “proximate,” or immediate cause of death.
p. 139 – There are no federal malpractice laws.
Office of the inspector general (OIG)
The OIG is one of the major players in the war against healthcare fraud.
This office was created to protect programs under the Department of Health and Human Services (HHS) such as Medicare and Medicaid.
The OIG reports problems to the Secretary of State and Congress makes recommendations on how to correct them.
The Office of Counsel to the Inspector General
• Provides legal services to the OIG
• Represents the OIG in civil cases tried under the False Claims Act.
• Imposes money penalties on healthcare providers found guilty of fraud.
• Issues fraud alerts
Federal statutes to avoid waste, fraud, and abuse in healthcare
Major areas of concern are:
1. Additional costs to federal healthcare programs
2. Quality of patient care
3. Access to care
4. Freedom of choice
6. Healthcare provider’s abuse of professional judgement
Violation of Statues
Ex: In some states a “poison” label is required by law (statute)
• A claim for payment for services or supplies that were never provided
• A claim using a diagnosis code other than the true diagnosis code to obtain reimbursement for services
• A claim indicating a higher level of service that that which was provided.
• A claim for a service that the provider knew was not necessary
• A claim for services provided by an unlicensed individual
Immunity for Charitable Organizations
Almost all states now reject immunity for charitable organizations on the basis that immunity encourages neglect and irresponsibility.
Defense to Malpractice Suits
The most common kind of defense; the physician denies he or she performed the procedure.
Statue of Limitations
The rule of discovery does not “run” if fraud was involved to cover the infraction.
This means “the thing that is decided.” If a court decides a case, the plaintiff cannot bring a new lawsuit on the same subject against the same defendant.
Fear of Lawsuits
(under Civil Liability Cases)
Fear of lawsuits has influenced the practice of medicine. Some hospitals or physicians are reluctant to withdraw or withhold treatment at the specific directive of a patient or family.
Physical conditions of the Premises
An institution may be liable when an accident occurs as the result of not following regulatory standards for maintaining a safe environment for patients.
Lawsuits involving the physical condition of medical facilities have involved cases such as broken steps, malfunctioning elevators and doors, and defective carpets.
Illegal Sale of Drugs
In healthcare settings were access to controlled substances is present, proper security measures must be taken. Failure to do so can result in loss of license, severe, penalty, and even prison for the offender.
A promise to cure a patient with a certain procedure or form of treatment is considered under contract law rather than civil law.
A comment made to a patient such as “I’m sure you will be fine.” could be taken as a verbal contract.
Uniform Business Records Act
Altered Medical Records
Any time that a medical record has the appearance of being altered or changed, it causes suspicion about the defendant’s motives.
Never completely obliterate any notation on a chart. If a note is placed in the wrong chart, cross through the notation with one line and write “Incorrect Chart” and you name.
It is poor technique to leave spaces on the chart so that another person can add statements later.
Deliberate attempts to alter or hide a chart can result in losing a negligence case, even weeks after the case is over (if the chart has been changed since last checked.)
The employer is liable for the consequences of the employee’s actions, no matter how well trained the employee is. However, a patient can sue both the physician and the employee. If both parties are found liable by the court the plaintiff may collect from either party, but not both. The employer, if not at fault, but forced to pay the plaintiff, can then sue the employee.
Many insurance plans are contingent on the insured person practicing good safety habits and providing a safe environment.
There are two major types of liability insurance:
• Claims-made insurance
• Occurrence (or claims-incurred) insurance
All licensed medical professionals should cary malpractice insurance. Unlicensed healthcare personnel, such as medical assistants, are usually covered under their employer’s policy, but many also carry their own.
traditional method for recording that uses storylike format to document information specific to client conditions and nursing care.
When done once per shift, does not always convey exactly what was done for the patient. To a judge, it may appear as “lack of monitoring.” It is different to defend a practice that is not documented.
Liability of other Health Care Professionals
• Medical employees who make repeated errors are not only liable for their errors, but are also subject to discharge.
• When nurses exceed their scope of practice, they violate their nursing license.
• Nursing supervisors have been found negligent for not establishing procedures for the nursing staff that are designed to protect patients.
• Most states have statutes that provide civil immunity for paramedics who provide emergency life-saving care.
• All healthcare professionals are required to report unusual situations to their supervisors.
• It is wise to talk to risk management about the need to complete an incident report whenever an unusual situation occurs. The report accurately reflects the time, date, and facts of the situation. It can be subpoenaed by the court in the even of a lawsuit.
(or Malpractice Reform)
According to the National Conference of State Legislatures, 32 states have passed reforms that limit an injured person’s ability to sue. In some states there is a cap on damage awards.
You have a duty not to inflict harm on the patient. Take everything you do seriously, even when you think it is not an issue. Always be careful what you say in front of a patient.
• Follow safety practices and OSHA guidelines
• Communicate clearly and within HIPAA
• Document accurately and completely
Tips for Writing Effective Cover Letters
• Don’t duplicate the wording in your resume
• Be positive
• Write clearly and concisely
• Don’t use overblown or empty words to describe your abilities
• Be truthful
• Emphasize your skills as a team player
• Incorporate specialized terminology
• Research the organization
• Read the letter aloud
Show Off Your Writing Skills
Demonstrate business writing skills.
Be concise, articulate, and convincing.
See p. 158
Steps to correct an error in a medical record and why is it important to do it correctly?
Draw a line through error so it is still legible, write above or below the correct information, note why the correction was made, date, time and initial, and have another witness the correction and add initials if possible – It’s important because it may appear to be due to falsification or cover up of entries, could be interpreted as evidence of guilt in a medical malpractice case.
Ownership of the “Physical Medical Record”
Is owned by the entity that created it, physicians office, clinic, hospital
Ownership of the “Content” of the record
Is owned by the patient.
What should the clinic employee do when requsted to release records to a third party?
Need written consent from the patient, Only the information requested should be released, check the specific dates and or time spans, check/verify name, check for authorization of release.
A collection of data recorded when a patient seeks medical treatment.
5 C’s of Charting
1)Concise. 2) Complete/Objective 3) Clear/Legibly written 4)Correct 5)Chronologically Ordered.
Doctrine of professional discretion
A physician can exercise a judgement as to whether to show patients who are being treated for mental or emotional conditions their recors; whether in the physicians judgement, it would do more harm than good.
Retention and Storage
Records should be kept until the statute of limitations has elapsed. – usually ranges from two to seven years. – in some cases this involves keeping the records of minors for a specified length of time after they reach legal age.
Confidentiality of Alcohol and Drug Abuse, Patient Records
A federal statute that protects patients with histories of substance abuse regarding the release of information about treatment.
Permission from a person either expressed or implied for something to be done by another
Doctrine of informed consent
The legal basis for informed consent, usually outlined in a state’s medical practice acts.
Implies that the patient understands – proposed modes of treatment, why the treatment is necessary, risks involved in the proposed treatment, available alternative modes of treatment, risks involved if treatment is refused. Important to have patient sign a consent form.
EXCEPTiONS who cannot give informed consent include:
Minors, Persons who are mentally incompetent, Persons who speak limited or no english.
Good Samaritan acts
Sate laws protecting physicials and sometimes other health care practitionners and laypersons from charges of negligence or abandonment if they stop to help the victim of an accident or other emergency. Consent is Unnecessary in emergency situations.
HIT – Health Information Technology
The application of information processing, involving both computer hardware and software, that deals with the storage, retrieval, sharing, and use of health care information, data, and knowledge for communication and decision making.
HIPAA – Health Insurance Portability Accountibility Act
mandates certain procedures and standards for the electronic transmission and storage of health care information.
HHS – Health and Human Services
results of HHS projects include: X-Rays over the internet, Lab results can be sent electronically, prescriptions can be sent eletronically.
EHR – Electronic Health Record –
Contains the same information as any medical record, but in electronic form.
Affirmative action programs
to remedy discriminating practices in hiring minority group members. Also covered under Title VII.
Courts may mandate that affirmative action programs be implemented if there is evidence that an employer has intentionally discriminated against a particular minority group.
Age Discrimination in Employment Act (ADEA) of 1967
protects persons 40 years or older against employment discrimination because of age.
• Applies to employers who have 20 or more employees.
• Does not apply if the older employee does not have the ability to perform the job
• The employer must be able to show in writing why the younger job applicant was hired over the older one.
• Mandatory retirement is prohibited under this law except for certain exempt executives.
• People over 40 are protected by ADEA and Title VII.
Americans with Disabilities Act (ADA) of 1973
prohibits employers who have more than 15 employees from discriminating against disabled individuals.
• There are 43 million disabled persons in the U.S.
• Persons with AIDS are also covered under this act.
• Employers must make reasonable accommodations to make the work environment accessible to their disabled employees.
• Exceptions occur if making the accommodations would put undue hardship for the employer.
• The vagueness of term “undue hardship” has caused problems interpreting this law.
• Employers have a 2 years to implement the accommodations.
• Patients are also protected under this statute.
As long as a person is competent, he or she has the right to make their own decisions.
Bioethical and legal issues arise when a person is called upon to make decisions based upon his or her own religious beliefs, for another person such as a child or incompetent adult.
Guardianship may have to be established by the courts so the best interested of the patient are observed.
unfair dislike or preference for something.
disease-producing microorganisms transmitted by means of blood and body fluids containing blood.
Civil Rights Act of 1991
p. 191 & 196
permits the court to award both compensatory damages and punitive damages to mistreated employees.
• Prior to this amendment only compensatory damages were awarded
• Wrongful discharge suits fall under this law.
• Hospitals cannot discriminate against employees and employees cannot discriminate against patients.
Clinical Laboratory Improvement Act (CLIA)
established minimum quality standards for laboratories.
• The federal government requires all clinical laboratories that test human specimens must be controlled.
• 1992 – mandate written policies and procedures for a comprehensive quality assurance program
• most tests are regulated except simple ones that would not negatively impact a patient if the result were erroneous
• The FDA is responsible for categorizing the tests and allowing the waiver of testing
• Tests performed at home are general waived but the manufacturer must request the waiver
• Tests that use a microscope, calculations, or a judgement call are not waived
• A complete list of waived tests is on hcfa.gov/medicaid/clia and www.cola.org
Consolidated Omnibus Budget Reconciliation Act (COBRA)
offers government financing for health insurance coverage continuation after an employee has been laid off a job.
• This is an important act because it has helped decrease the number of uninsured Americans.
• A company with 25 or more employees must provide extended healthcare insurance to terminated employees for up to 18 months – usually at the employee’s expense.
• COBRA also contains an amendment called EMTALA which prohibits “patient dumping”
person or institution to whom a debt is owed.
person who owes money to another person.
unfair or unequal treatment.
Drug Free Workplace Act of 1988
employers contracting to provide goods or services federal government must certify that they maintain a drug free workplace.
• Drug-using employees are expensive in terms of decreased productivity, workplace, accidents, and increased healthcare costs.
• To prevent abuse some organizations require drug testing as a condition of employment.
Emergency Medical Treatment and Active Labor Act (EMTALA)
a section of COBRA dealing with patient dumping.
• Patients must be stabilized before transfer or sent to a regional trauma center if they cannot be stabilized
• A person reporting patient dumping may not be peanalized
• Hospitals can be fined or have their Medicare agreements dropped
• The patient can sue the hospital
• A physician can be penalized if he/she misrepresents a patient’s condition
• EMTALA does not apply to HMOs, private clinics, or private phusician’s offices.
Employee Retirement Income Security Act (ERISA)
p. 194 & 206
regulates employee benefits and pension plans.
• ERISA requires employers to earmark money that can only be used to pay future benefits.
• Guarantees vesting of pension plans
• Under ERISA, employees who stay with a company for 10 years are entitled to 50 percent of the employer’s retirement plan even if they leave the company and take another job.
• The employee is entitled to 100% of the employer’s pension contribution after fifteen years of employment when he or she becomes fully vested.
• ERISA protects employees from being laid off just before they become vested.
a common-law doctrine of employment that takes place at either the will of the employer or the employee when a contract is not present. Employment may be terminated at will, without notice, at any time,and without a reason. An employee may quit at any time. The only protection is that employees cannot be fired for an illegal reason (race, religion, etc.)
This does not apply if there is a contract between the employer and employee that defines the duration of the employment.
This concept is beginning to lose favor as wrongful-discharge lawsuits rise.
Equal Credit Opportunity Act of 1975
prohibits businesses (including hospitals) from granting credit based on race and gender—unfair treatment is referred to as discrimination.
Equal Employment Opportunity Act (EEOA) of 1972
p. 193 & 197
authorizes the EEOC to sue employers in federal court on behalf of people whose rights have been violated under Title VII.
Equal Employment Opportunity Commission (EEOC)
monitors Title VII of the Civil Rights Act. It has strict guidelines on the types of questions that can be asked during a job interview.
• EEOC monitors Title VII and the Justice Department enforces the statute.
Equal Pay Act of 1963
Makes it illegal for an employer to discriminate on the basis of gender in the payment of men and women who are doing the same job.
a belief that one’s cultural background is better than any other
Fair Credit Reporting Act of 1971
establishes guidelines for use of an individual’s credit information
• If a patient is denied credit based on a poor credit rating from a credit agency, the patient must be notified of this fact and given the name and address of the reporting agency.
• The agency must disclose the information to the consumer and correct any outdated or erroneous information.
Fair Debt Collection Practices Act of 1987
prohibits unfair collection practices by creditors.
• The FCC issued guidelines for specific times that credit collection phone calls can be made (8 a.m. – 9 p.m.)
• It prohibits harassment and threats
• Guidelines on page 209
• Billing and collections personnel must have a full understanding of the laws regulating the collection process
Fair Labor Standards Act (FLSA)
establishes the minimum wage, requires payment for overtime work, and sets the maximum hours employees covered by the act may work.
• This is the main statute regulating employee benefits.
• Over time must be provided at time and a half if over 40 hours are worked each week
• Hospitals are an exception when they make an agreement with their employed to establish a work period of 14 days. Overtime then starts at 80 hours.
• This law affects only full-time, hourly employees.
• Salaried, management, part-timers, and time-sharers usually do not benefit from this law.
Family and Medical Leave Act (FMLA) of 1994
allows both the mother and the father to take a leave of absence for up to 12 weeks, in any 12-month period, when a baby is born.
• The employees job, or an equivalent position, must be held.
• In most cases the leave is without pay.
• FMLA also allows an employee to take 12 weeks for a family members medical situation (birth, death, adoption).
• The employees heath coverage must be maintained
• Accumulated employee benefits cannot be lost
Federal Insurance Contribution Act (FICA) of 1935
requires employers to contribute to Social Security for employees.
• The oldest act relating to compensation.
• Employers are required to contribute to Social Security plans for their employees.
• Severe fines ensue if the employer does not pay on time.
• Detailed documentation of the employer’s payments are necessary
Federal Wage Garnishment Law
restricts the amount of the paycheck that can be garnished to pay off a debt.
court order that requires an employer to pay a portion of an employee’s paycheck to one of the employee’s creditors until the debt is resolved.
National Labor Relations Act of 1935
The Wagner Act
prohibits employer actions, such as attempting to force employees to stay out of unions, and labels these actions as “unfair labor practices.”
Occupational Safety and Health Act (OSHA) of 1970
requires an employer to provide a safe and healthy work environment; the employer must protect the worker against hazards.
• OSHA regulations preempt all other state and local regulations regarding employee safety and health, meaning that states may not pass any laws concerning the working environment.
• Right-to-know laws
• Employers and office managers should become familiar with OSHA regulations as they apply to their specific fields. This protects employees and avoids fines for OSHA violations which can be severe.
• Poor publicity from OSHA violations can damage an office or company’s reputation.
• It is better to err on the side of being to cautious when implementing OSHA regulations.
medication route other than the alimentary canal (oral and rectal), including subcutaneous, intravenous, and intramuscular routes.
a slang term for transferring patients from one hospital to another if the patient is unable to pay for services.
Pregnancy Discrimination Act of 1978
employers must treat pregnant women as they would any other employee, providing they can still do the job.
• An employer cannot force a woman to quit her job because she is pregnant
• A woman cannot be refused a job because she has had an abortion
• The employer’s medical plan must cover pregnancy the same way it covers medical conditions.
• The woman is entitled to sick leave the same as other employees
Rehabilitation Act of 1973
prohibits employers from discriminating against the handicapped.
• This act prohibits discrimination based on disability in any institution that receives federal financial assistance. (e.g., a hospital that receives Medicare or Medicaid reimbursement must comply with this law).
• This act had a major influence on the Americans with Disabilities Act of 1990 because it included a broad definition of “handicapped” (people with physical or mental impalement)
• This act give legal basis for claims challenging denial for employment because of physical or mental reasons.
Social Security Act of 1935
federal law that covers all private and most public sector employees.
• This act laid the groundwork for unemployment compensation in the United States.
• Social Security is paid by the employer and the employee in equal payroll taxes and Medicare participant premiums.
• Social Security is composed of different but related programs:
– Medicare health benefits
• The amount paid to the beneficiary is calculated based on the worker’s average wages earned during his/her working lifetime.
negative generalities concerning specific characteristics about a group are applied to an entire population.
Title VII of the Civil Rights Act
prohibits discrimination in employment based on five criteria: race, color, religion, gender, or national origin.
• This proposal from the Kennedy administration is considered one of the most important pieces of all legislation.
• This act applies to all organizations that have 20 or more employees working 20 or more weeks a year.
• Some of the most frequent violations in the healthcare employment field are related to Title VII issues.
• Title VII also makes sexual harassment a form of unlawful sex discrimination.
Truth in Lending Act (Regulation Z) of 1969
Regulation Z of the Consumer Protection Act
requires a full written disclosure about interest rates or finance charges concerning the payment of any fee that will be collected in more than four installments.
• Installment payments are often used for orthodontia, obstetrical care, and surgical treatment.
• It is legal to include a finance charge, however, few physicians and dentists require the charge.
provides for temporary weekly payments for the unemployed worker who lose their job through no fault of their own.
• In order to receive unemployment insurance, the employee must have worked for an employer who has paid, or was required to pay, unemployment compensation taxes.
• Exemptions apply for religious, educational, or charitable organizations.
• Employees who are fired for a good cause cannot collect unemployment benefits.
a point in time, such as after 10 years of employment, when an employee has the right to receive benefits from a retirement plan.
Worker’s Compensation Act
protects workers and their families from financial problems resulting from unemployment related injury, disease, and death.
• Employers typically pay into a fund to help cover costs when a worker is hurt during the course of employment.
• The goal of worker’s compensation is to get the worker pack to work as soon as possible.
• COBRA may allow for a retraining opportunity if the injury results in permanent inability to work the same job
• If the employee has only worked at the job a few months, the former employer may have to pay worker’s compensation.
• Some medical practices specialize in worker’s compensation cases
• Worker’s Compensation is completely administered at the state level
• The employee must submit written notice of the injury to the employer
• Worker’s Compensation pays a fraction of the normal salary, such as 2/3.
• Available even if the employee is at fault for the injury, except employees who violate hospital policy
• An employee who is injured by a nonemployee can collect Workman’s Compensation and sue the nonemployee for damages.
lawsuit in which the employee believes the employer does not have a just cause, or legal reason, for the firing.
Discuss the regulations concerning equal employment opportunity and employment discrimination.
Occupational Safety and Health Act (OSHA) of 1970—Under OSHA, an employer is required by law to provide a safe and healthy work environment. The employer must protect the worker against hazards.
Clinical Laboratory and Improvement Act (CLIA) of 1988, 1992—The federal government now requires that all clinical laboratories that test human specimens must be controlled. These standards mandate written policies and procedures for a comprehensive quality assurance program to evaluate the overall quality of the laboratory testing process.
Health Maintenance Organization (HMO) Act of 1973—This act requires any company with at least 25 employees to provide an HMO alternative to regular group insurance for their employees if an HMO is available in the area.
Consolidated Omnibus Budget Reconciliation Act (COBRA) of 1985—Under COBRA, a company with 20 or more employees must provide extended healthcare insurance to terminated employees for as long as 18 months—usually, but not always, at the employee’s expense.
Drug-Free Workplace Act of 1988—Under this act, employers contracting to provide goods or services to the federal government must certify that they maintain a drug-free workplace.
Discuss the regulations affecting employee compensation and benefits.
Social Security Act of 1935—This federal law covers all private and most public sector employees. It laid the groundwork for unemployment compensation in the United States. Social Security is paid by the employer and the employee in equal payroll taxes and Medicare participant premiums.
Fair Labor Standards Act (FLSA) of 1938—This is the main statute regulating benefits. It establishes the minimum wage, requires payment for overtime work, and sets the maximum hours employees covered by the act may work.
Equal Pay Act of 1963—This act makes it illegal for an employer to discriminate on the basis of gender in the payment to men and women who are performing the same job.
Unemployment Compensation—The unemployment compensation laws provide for temporary weekly payments for the unemployed worker.
Federal Insurance Contribution Act (FICA) of 1935—Under this law, employers are required to contribute to Social Security plans for their employees.
Workers’ Compensation Act—This statute protects workers and their families from financial problems resulting from employment-related injury, disease, and even death.
Employee Retirement Income Security Act (ERISA) of 1974—ERISA regulates employee benefits and pension plans.
Family and Medical Leave Act (FMLA) of 1994—This law allows both parents to take a leave of absence of up to 12 weeks in any 12-month period when a baby is born. The employees’ jobs, or equivalent ones, must be available when both return to work. The FMLA also requires employers
to provide unpaid leave for up to 12 weeks to employees who request leave for their own or a family member’s medical or family-related situation, such as birth, death, or adoption.
Give examples of regulations affecting consumer protection and collection practices
• Emergency Medical Treatment and Active Labor Act (EMTALA)—A section of the Consolidated Omnibus Budget Reconciliation Act (COBRA) dealing with “patient dumping.”
• Fair Credit Reporting Act of 1971—This act establishes guidelines for use of an individual’s credit information.
• Equal Credit Opportunity Act of 1975—This act prohibits businesses, including hospitals and medical offices, from denying credit based on the applicant’s race or gender—an unfair treatment referred to as discrimination.
• Truth in Lending Act (Regulation Z) of 1969—This act requires a full written disclosure about interest rates or finance charges concerning the payment of any fee that will be collected in more than four installments.
• Fair Debt Collection Practices Act of 1978—This act prohibits unfair collection practices by creditors.
• Federal Wage Garnishment Law—This law restricts the amount of the employee’s
paycheck that can be used to pay off a debt (garnishment).
Describe accommodations that can be made in the workplace for persons with disabilities.
• Parking spaces, marked for the handicapped, near an accessible doorway
• Inclined ramps into buildings and over curbs in parking lots
• Elevator floor numbers accessible to wheelchair-bound persons
• Handicapped accessible bathrooms with handrails
• Hallways with 36 inches of clearance for a wheelchair
• Desks and counters that accommodate a wheelchair
• Telephone adapters for the hearing impaired
List several questions that may be legally asked during an employment interview
a. Age—Only legal to ask if he or she is between 17 and 70; if the person’s age falls outside this boundary, then it is legal to ask only the birth date.
b. Birthplace—Legal, but inadvisable to ask where the applicants, their parents, spouse, or children were born. It is illegal to ask about their national heritage or nationality or that of their spouse.
c. Address—Legal to ask, along with how long applicant has lived there.
d. Married/Maiden Name—Legal, but inadvisable.
e. Citizenship—Legal to ask, “Are you a citizen of the United States?”
f. Organizations person belongs to—Legal to ask if applicant belongs to any organizations.
g. Languages—Legal to ask what language a person can speak and write, but can be perceived as discriminatory and a method to determine a person’s national origin.
h. Military experience—Legal to ask if person was a member of the armed forces and when he or she was discharged. Cannot ask what type of discharge was received.
i. If ever convicted of a crime—legal.
a. Age—Cannot ask for the applicant’s specific age if it falls between 17 and 70.
b. National heritage or that of applicant’s spouse.
c. If applicant rents or owns home.
d. If applicant has children.
e. Height and weight.
f. Race or color.
g. Religion or creed.
h. If applicant has ever been arrested.
i. Any handicaps.
j. Memberships in any specific organizations.
k. What type of military discharge.
Recommendations for Good Hiring Practices
a. Develop clear policies and procedures on hiring, discipline, and termination of employees.
b. Effectively screen backgrounds.
c. State in writing that the employee handbook is not a contract.
d. Use a two-tier interview screening process.
e. Carefully assess the applicant’s skill level.
f. Develop an application form that provides accurate information about the applicant’s qualifications.
g. Provide a job description for every position.
h. Develop a progressive disciplinary procedure and make this policy known to all employees and supervisors.
i. Provide in-service training to supervisors on how to conduct job interviews and how to motivate and discipline employees.
j. Become familiar with the legal and illegal employment interview
Professionalism in the Workplace
p. 188 – Efficiency is getting the job done; effectiveness is doing the job right!
p. Employees should receive a 30 minute lunch break and 2 two 15 minute breaks during each 8-hour work day. The exact policy is established by individual states by the Department of Labor.
Discrimination in the Workplace
Privacy and the Workplace
Opening a patient’s medical file should always be on a “need to know” basis. Any other reason may constitute an illegal action.
• Hygiene Practices
Keep one’s opinions about he use of deodorants, clean clothing, and frequent bathing to oneself, unless the patient’s health is suffering as a result of poor hygiene conditions.
Communication is a challenge for non-English speakers. The nods for “yes” and “no” may be switched.Non-English-speaking-patients need brochures, and handouts in their own language. An interpreter must be available when explaining important information.
Tips for Avoiding the Negative Behaviors of Stereotyping, Bias, and Ethnocentrism
• Be aware of your coworker’s and patients’ beliefs
• Learn as much as you can about other cultures, races, and nationalities.
• Be sensitive to the feelings of others
• Evaluate all information before accepting it as belief
• Always avoid ethnic jokes. Walk away if a co-worker is telling ethnic or disrespectful joke
• Be open to differences in other people
• Advance directives, consent to treatment, and the use of birth control devices are often influenced by a person’s religious beliefs. In some cases, it may mean rejecting medical interventions such as blood transfusions or it may mean a patient rejects all medical care.
• Bioethical and legal issues arise when a person is called upon to make decisions based upon his or her own religious beliefs, for another person such as a child or incompetent adult.
• Guardianship may have to be established by the courts so the best interested of the patient are observed.
• It is never appropriate to judge, either with verbal or nonverbal criticism, another person’s religious customs and beliefs. A exception occurs when there is evidence of abuse as a result of a religious practice.
• There are some beliefs that do not allow a person to receive a blood transfusion. When the patient is a child, a court order is needed for the transfusion to proceed against the objections of the parents.
• Employers has a legal obligation under the Civil rights Act to make accommodations so that employees can practice their religious observations.
Effective Hiring Practices
• Employee handbooks should clearly state that they are not contracts and should be carefully examined for any erroneous or misleading statements.
• Employees should be allowed to see, comment on, or copy anything affecting them in written review and personnel file memos.
Federal Regulations Affecting the Medical Professional
• Both state and federal laws regulate the employer and employee relationship.
• Healthcare facilities must remain current on regulations affecting employment practices such as health, safety, compensations, worker’s compensation, unions, and discrimination laws.
• In general federal law usually applies to organizations that employ a declared number of employees and who work a minimum number of weeks in the year.
• Usually, federal law preempts state laws. An exceptions occur when:
– there is no federal law on the topic
– the state law does not conflict with the federal law
– Congress prohibits states from regulating a certain law by complete preemption
Major categories of federal laws regulating the employer-employee relationship
• equal employment opportunity and employment discrimination
• employee health and safety
• compensation and benefits regulations
• consumer protection and collection practices
• federal labor acts
Equal Employment Opportunity
The government regulates the employment relationship, including laws affecting:
• pay plans
The basis of the law is that people must be judged primarily by their job performance.
Equal Employment Opportunity and Employment Discrimination Laws
a Latin term meaning “something for something”.
Who is an Employee Under Title VII?
If an employer witholds employment taxes from a person’s income, than that person is considered an employee.
Who Is an Employer Under Title VII?
A person who employs the services of another and provides payment for those services is considered an employer. The employer has the right to control the physical conduct of the employee in performing the service. The statute does not apply to independent contractors. Parent companies are not liable under Title VII.
Basic accommodations that can be made for persons with disabilities include:
National Labor Relations Board (NLRB)
Enforces the National Labor Relations Act
National Employee Health and Safety Laws
Employee Health and Safety
Both state and federal laws regulate issues affecting an employee’s health and safety. State law can be stricter than the federal law, it cannot be more lenient.
laws that give employees access to workplace safety information.
OSHA Occupational Exposure to Bloodborne Pathogens Standards
• Fines up to $7,000 per violation
• All healthcare workers have occupational exposure
• OSHA standards mandate that each employee with occupational exposure must be offered the hepatitis B vaccination at the expense of the employer. An employee may decline, in writing, to receive the vaccine.
• The OSHA standard refer to urine, stool, sputum, nasal secretions, vomitus, adn sweat only if there is visible evidence of blood.
• OSHA compliance checklist for medical facilities includes:
– eyewash stations
– fire extingishers
– first-aid kits
– written training programs
– labels for chemical and hazardous waste
– sharps containers
– exit signs
– spill kits
– accident report forms
– chemical inventory lists
• OSHA guidelines are available from the U.S. Department of Labor, Washington, D.C.
a reasonable anticipation that the employee’s duties will result in skin, mucous membrane, eye, or parental contact with bloodborne pathogens or other potentially infectious material.
List of Potentially Infectious Materials
Hazard Communication Standard (HCS)
• An OSHA standard meant to reduce injuries and illnesses in the workforce by alerting healthcare employees to potential dangers and risks when using hazardous chemicals and materials.
• MSDS must be posted wherever hazardous materials are used.
• Employees are instructed to read the sheets and know how to handle the materials.
Material Safely Data Sheets
List of CLIA Laboratory Requirements
Health Maintenance Organization Act (HMO) of 1973
requires any company with at least 25 employees to provide an HMO alternative to regular group insurance for their employees if an HMO is available in the area
Compensation and Benefits Regulations
These laws influence the compensation (salary) and benefits provided to employees.
• Employees “earn” a certain number of paid sick days per year based on the number of hours worked.
• These can be saved up and used when the employee has to take time off for an illness or surgery.
• Sick days are not part of earned vacation days. They cannot be used except for sickness.
Consumer Protection and Collection Practices
Guidelines for Collection Efforts
is a legal method for providing some protection to individual debtors who owe money by establishing a fair method of distribution of the debtor’s assets to all the creditors.
• Once a debtor files for bankruptcy, a creditor (such as a physician who is owed an outstanding debt) may no longer seek payment from the patient, but must instead file a claim in bankruptcy court at a later date.
• A creditor who fails to comply with bankruptcy laws, such as harassing the debtor, can be cited for contempt of court.
Claims against Estates
• When a patient dies, a bill should be sent to the estate of the deceased.
• Follow up with bill collection to avoid the impression that the physician was at fault in the patient’s death
• The probate department of the superior court in the county that is handling the estate can provide information on the time limits and also name the administrator of the estate.
The Statue of Limitations
This statute defines how long a medical practice has to file suit to collect on a past-due account.
• The time limit varies from state to state
• Consult with an attorney
• If an aging account is more than three years old, the creditior should investigate the state’s statute of limitations before investing time, effort , and money to collect the debt.
• Avoid issues by collecting debts as soon as possible
All of the written documentation relating to the patient. It includes past history information, current diagnosis and treatment, and correspondence relating to the patient.
Problem-Oriented Medical Record (POMR)
Medical charting that includes the chronological record of each visit.
Subjective, objective, assessment plan. Subjective statements of the patient. Objective data such as lab reports, vital signs, etc. Assessment or diagnosis. Plan of treatment.
timeliness of documentation
All entries should be made as they occur or as soon as possible afterward. Federal reimbursement guidelines mandate that all medical records should be completed within 30 days following the patient’s discharge from a hospital.
Believable or worthy of belief, trustworthy, and reliable.
An apparent disparity between what is said or written and the actual facts.
Confidential information that has been told to a physician (or attorney) by the patient.
doctrine of professional discretion
That a physician may determine, based on his or her best judgment, if the patient with mental or emotional problems should view the medical record.
Privacy Act of 1974
Federal agencies and government contractors may maintain only information relevant to its authorized purpose. Citizens have the right to gain access to records and to copy records if necessary.
State freedom of information laws that grant public access to records maintained by state agencies.
Public Health Services Act
Protects patients who are receiving treatment for drug and alcohol abuse.
electronic media record (EMR)
Fully computerized method of record-keeping of all patient-related data.
Scrambling and encoding information before sending it electronically.
Software to prevent unauthorized users.
Miniaturized photographs of records.
Healthcare providers and institutions may face civil and criminal liability for releasing medical records without proper patient authorization.
all covered entities must be in compliance
wireless systems to send and receive data
Health Insurance Portability and Accountability Act of 1996
number assigned to to an employer
a billing service
individual or group that provides or pays for medical care
individually identifiable information
use of information technologies to treat people at a distance
employer identifier standard
based on employer’s tax ID or on their EIN
Department of Health and Human Services
The Privacy Rule is meant to ensure
a and b only (standardization of health data and standardization fo financial data
An example of a clearing house is
a billing service
The government organization that investigaes a violation of a patient’s medical privacy is called
A network of wireless communication systems used to access patient record is
The privacy law
does not apply to most police and fire departments
A violation of HIPAA
is a criminal offense
When implementing HIPAA, physicians and physician groups should
all of the above (hire a privacy officer, implement a notice of privacy practices, retain signed authorizations for at least six years, and enter into written agreements with nonemployee service providers)
Covered entities include all of the following except
Patients’ rights under HIPAA include the ability to
a, b, and c (examine their medical record, have a full copy of their medical record, and complain to the HHS if they believe their is a violation of privacy
When patient information is requested via a subpoena, you must
provide all PHI that is requested in the subpoena
The study of healthcare ethics is an applied ethics, which means that it is more than just a study of theory. Students need to understand the role of ethics in the practice of their medical discipline. A critical-thinking approach to ethics requires the student to look for a solution that includes fairness to patients, respect for society, and a concern for the future implications of the decision. This must be a decision in which the dignity of the individual is always respected. This chapter includes a brief history of ethics, codes of ethics, and a discussion of ethics committees. Bioethical issues such as transplant rationing, biomedical research, and conflicts of interest are included. Three models for examining ethical dilemmas are included in Chapter 1.
to assert or declare without proof.
—to find fault with, criticize, or condemn.
• Physicians accused of unethical behavior can be issued a warning or censure by the AMA.
—threadlike structures within the nucleus (center) of a cell that transmit genetic information.
—a group of identical matching cells that come from a single common cell.
—research subjects who receive no treatment.
—a research design in which neither the experimenter nor the patient knows who is getting the research treatment.
—the administration of a lethal agent by another person to a patient for the purpose of relieving intolerable and incurable suffering.
—list of genes that are responsible for disease.
—the replacement of a defective or malfunctioning gene.
—a science that describes the biological influence that parents have on their offspring.
—remove organs or embryos.
—the complete set of genes within the 23 pairs of human chromosomes.
Human Genome Project
—a research program funded by the federal government to “map” and sequence the total number of genes with the 23 pairs, or 46 chromosomes.
Institutional Review Board (IRB)
—a hospital or university board of members who oversee any human research in that facility.
National Organ Transplant Law of 1984
—federal law that forbids the sale of organs in interstate commerce.
—research conducted that will not directly benefit the research subject.
—the act of taking away or recalling, such as taking away a license to practice medicine.
Social utility method of allocation
—a method of determining the allocation of organs by giving them to people who will benefit the most.
—master cells in the body that can generate specialized cells.
—a form of medical research that might directly benefit the research subject.
United Network for Organ Sharing (UNOS)
—the legal entity in the United States responsible for allocating organs for transplantation.
List and discuss at least ten bioethical issues the modern physician and healthcare professional faces. Answers may include:
allocation of scarce health resources
determination of death
euthanasia: active and passive
fetal tissue research
harvesting of embryos
HIV, AIDS, and ARC
organ donation and transplantation
random clinical trials
stem cell research
withholding lifesaving treatment
Describe how an ethical decision-making model can be used when confronted with difficult ethical dilemmas.
An ethical model, such as the seven-step model, can help when confronted with an ethical dilemma, to problem solve instead of following a gut reaction. Furthermore, it requires that one examine all the facts and look at alternative solutions before coming to a conclusion.
Discuss ethical issues relating to genetic testing.
Describe the advances in human stem cell research.
New information is coming out about stem cell research almost weekly. These master body cells can generate specialized cells that can grow into any cells or tissue in the body. It is believed that the use of stem cells will eventually allow the body to heal itself from diseases such as Parkinson’s, diabetes, stroke, and Alzheimer’s.
Summarize the ethical issues of organ transplantation.
The ethical concerns for this issue are wide-ranging but include determining who receives a scarce organ, the expense of a transplant, and the sale of organs.
Discuss the importance of codes of ethics such as the Nuremberg Code and the Declaration of Helsinki.
These codes were developed as a direct response to atrocities that occurred during wartime, especially in response to the medical experimentation in Nazi concentration camps during World War II. These codes express concern for the human subject in medical experimentation.
• Healthcare ethics, bioethics and medical law are intertwined.
• Ethics (a branch of philosophy) in healthcare are applied ethics.
• Ethics requires critical-thinking approach that examines important considerations such as fairness for all consumers, the impact on society, and future implications of the decision.
• The dignity of the individual, whether it is the patient, employee,or physician must always be of paramount concern when discussing ethics and bioethics.
• Bioethics concerns ethical issues discussed in the context of advanced medical technology.
• An illegal act is almost always unethical. However, an unethical act may not be illegal.
• The Hippocratic Oath reminds students of the importance of their profession, the need to teach others, and the obligation to never knowingly harm a patient or divulge a confidence.
• The same principles are found in the AMA’s code of ethics.
Ethical Standards and Behaviors
• According to the AMA, ethical behavior refers to moral principles or practices, the customs of the medical profession, and matters of medical policy.
• Physicians accused of unethical behavior can be issued a warning or censure by the AMA.
• The AMA Board of Examiners may recommend the expulsion or suspension of a physician from the AMA, but it does not have authority to bring legal action against a physician.
• The AMA is required to report to the state licensing board or governmental agency if someone alleges that a physician has committed a criminal act.
• Violation and conviction may result in a fine, imprisonment, or revocation of the physician’s license.
• Serious cases of fraud require the loss of a physician’s license.
• People’s behavior must match their set of values.
• Codes of Ethics or statements of intent are developed by professional organizations to summarize the the principles of behavior they expect of their practitioners.
• The Nuremberg Code was developed in response to a wartime medical ethic atrocities; it outlines the basic ethical principles that must be followed when conducting medical research
• The first AMA Code of Ethics was developed in 1847. Since then the AMA has taken a leadership role in setting such standards.
• Know the code of ethics that relates to your professional practice. Many healthcare professionals keep a framed copy near their place of work to remind them of this responsibility.
American Medical Association (AMA)
Principles of Medical Ethics
The AMA Principles of Medical Ethics discuss
• Human dignity
• Responsibility to society
• The need for continued study
• Patient autonomy
• Responsibility of the physician to improve the community
• Responsibility to the patient
• Access to medical care
Every healthcare professional who interacts with patients (even medical receptionists) must be familiar with the Principles of the AMA.
Judicial Council Opinions of the AMA
• The Council on Ethical and Judicial Affairs of the AMA is compromised of nine members who interpret the Principles of Medical Ethics. Issues include:
• Accepting patients
• Allocations of health resources
• Confidential care of minors
• Fee splitting
• Financial incentives for organ donation
• Gene therapy
• Ghost surgery
• HIV testing
• Mandatory parental consent to abortion
• Physician-assisted suicide
• Quality of life
• Withholding or withdrawing life-prolonging treatment
Codes of Ethics for Other Medical Professionals
ANA – American Nurses Association
AAMA – American Association of Medical Assistants
ADA – American Dietetic Association
AHIMA – American health Information Management Association
ASMT – American Society for Medical Technology
ASRT – American Society of Radiologic Technologitst
Nurses’ Code of Ethics
The American Nurses Association (ANA) has developed a code for nurses.
Code of Ethics for the American Association of Medical Assistants (AAMA)
New bioethical issues arise almost daily due to advances in medical technology.
Organ and Tissue Donation
In the United States people may voluntarily donate their organs and tissues to others. They can indicate this desire in their advance directive or on their driver’s license (in some states).
• The most commonly donated are corneas, heart, kidneys, skin, bone marrow, blood, liver, and lungs. The long bones of the body (tibia, fibula, femur, humerus, radius, and ulna) can also be transplanted.
• Some organs and tissues can be donated by a living person, such as, blood, bone marrow, and kidneys.
• A U.S. law prohibits the sale of organs. Payment to cover the medical cost for the donor is allowed.
• UNOS contains a database relating to every organ donation and transplant in the U.S. since 1986.
• UNOS uses a formula that gives half the weight to considerations of medical untility or need and half to considerations of justice.
• An estimated 400,000 people are waiting for transplant in the U.S.
• There are 106,000 people listed on the UNOS waiting list (many are for kidneys)
• Severe shortages of organs leaves patients to take desperate measures to find organs on their own
The Ethics of Transplant Rationing
• Transplant rationing is one of the most discussed bioethic issues
• One issue is the extreme expense involved for the procedure and continued immune suppression therapy
• The criteria for rationing are controversial.
• The United States and Great Britain are committed to the donation model for organs; organs may be harvested only with the consent of the donor or the donor’s surrogate representative.
• All U.S. states have adopted the Uniform Anatomical Gift Act, permits competent adults to either allow or forbid the posthumous use of their organs though some type of written document, including a donor card.
• The social utility method of allocation determines the allocation of organs based on who will benefit the most through careful matching and estimated survival rate.
• Another approach is the justice method, which gives everyone an equal change at the available organs.
• Other methods include seniority (first come, first serve) basis and the lottery method. Both of these methods cause concern because they may result in a person in lesser need receiving an organ first. The lottery method may result in a patient with little chance of recovery, receiving a scarce organ.
• Other selection criteria, such as age, social status, projected ability to give back to the community raise concerns that this is not a just system for all persons.
• A combination approach using medical suitability first and then seniority basis second is the most often used method.
• National Organ Transplant Law of 1984 forbids the sale of organs and addresses the matter of finding donor organs close to recipients locations.
• Financial incentives for cadavers is generally frowned upon
• Medicare has been expanded to fully fund kidney transplants and most insurance will cover heart transplants.
• Lessons learned from the Oregon case are:
– Medical resources are limited in all states
– The need for acute care, such as for transplants, is more visible than preventative care, such as prenatal care
– New medical discoveries and treatments, with their enormous costs, are likely targets for cost containment rather than older, more basic medical treatments.
– For new treatments to be funded, they must replace older, ineffective treatments
Information about Organ Transplants
Ethical Issues and Personal Choice
• Healthcare professionals may have personal, religious, or ethical reasons for not wishing to be involved in a particular procedure.
• The preference should be stated before hiring takes place.
• If the healthcare providers reasons jeopardize the health and safety of the patient it may be necessary for them to resign.
• The ethics of the employer must be in agreement with the ethics of the healthcare professional.
The Ethics of Biomedical Research
• Aims of healthcare include:
– the relief of pain and suffering
– the restoration of body functions and health
– the prevention of disability and death
• Human experimentation is considered necessary for medical progress to occur
• Medical research carries some degree of risk and patients must be willing, informed participants, especially in nontherapeutic research
• The justification for all research is that the benefits must outweigh the risks.
• This utilitarian (benefit/cost) approach is considered a good model for research.
• Increasing knowledge is not considered justification for risking human life
• Medical researches must abide by the code of ethics established by their professional organizations
• HHS implements government standards for research. They require all institutions that receive federal research funds to establish an Institutional Review Board (IRB) to oversee any human research.
• Informed consent is necessary in therapeutic research
• Patients must be informed about the risks and they type of research design that is used. Such as:
– Control group
– Randomized study in which the subjects is assigned at random to either the control or experimental treatment group
– Placebo group in which an inactive substance or an alternative type of treatment is given
When Research Can Resolve Debate over the Best Treatment
• Ethics becomes a concern when research results prove that the type of treatment subjects have been receiving has actually harmed patients.
• Research can help determine the which course of treatment is best
• Physicians are responsible for explaining the risks involved in a research project, however, other healthcare professionals have a duty to covey information the patient tells them to the doctor.
Conflict of Interest
• A conflict of interest can arise in research if the researcher’s interests are put above the patients’. As when a researchers falsifies data so they continue to receive funding.
• Physicians should not engage in drug trials for drugs made by companies that they own stock in.
Department of Clinical Bioethics
at the National Institute of Health Clinical Center
Dear Doctor Letter
Ethics of Randomized Test Trials
• Many ethicsists believe that control groups are unethical because that group cannot benefit form the experimental drug
• Race based control groups create another ethical dilemma because people of a certain race may not receive treatment
• However, race based control groups are necessary when researching a condition that only affects that particular race
Problems with the Double-Blind Test
Considered to be an objective means of gathering test data because it eliminates bias, an ethical question still arises. Is the process of informed consent adequate when the patient does not know if they are receiving treatment or not.
Human Genome Project
The goal of the Human Genome Project is to provide a map of where each gene is located on the 23 pairs, or 46 chromosomes.
The ability to alter the basic structure of life to correct a malfunction is the goal of genetic engineering. Moral and ethical concerns are raised by critics who say that manipulation the human genetic code is akin to playing God.
• Researches claim that a major reason for developing cloning in animals is to permit the study of genetic development and genetic diseases.
• Arguments against human cloning is the effect it might have on human dignity.If we control the creation of human beings, then we can eliminate the creation of imperfect human beings.
• Three more oppositions to cloning are:
– health risks from mutated genes
– emotional risks
– the risk of abusing technology
• Also,since therapeutic cloning destroys a 4-d-ay-old embryo, many anti-abortionists are against it.
A needed gene is spliced onto the DNA of a body of cells to control the production of a particular substance.
• This could cure some diseases but there are unanswered questions such as:
– Should gene therapy be used to create healthier fetuses?
– Should companies develop tests to predict mental illness?
– Could gene therapies, designed to save lives, end up being a way to choose the traits we want our children to have?
Human Stem Cell Research
• Stem cells can be used to treat Parkinson’s disease, Alzheimer’s, disease, stroke, and diabetes.
• The controversy revolves around the moral implications of using human embryos to obtain stem cells.
• Embryos are grown in the lab, in-vitro fertilization left overs and from abortions.
• Congress has banned all federal funding of stem cell research
• The FDA has little jurisdiction over embryonic research
• States have widely opposing views
• The ban on stem cell research was lifted in 2009
• Research using stem cells from sources other than embryos is less controversial.
• Some fear there are dangers of starting a practice that is ethically questionable
Induced Pluripotent Stem Cells
Somatic cells that are genetically reprogrammed to differentiate differently
►Occurs when employees publicly report a potentially dangerous situation in their organization to authorities who can take corrective action. The employee must:
• Exhaust all other channels for correcting the situation within the organization
• Have documented evidence that would convince an impartial and reasonable observer.
• Have a good reason to believe that by “blowing the whistle” and going public the necessary changes will be made to prevent harm and injury.
► Anonymous complaints can be made to reulatory agencies like the EPA or OSHA.
►The Occupational Safety and Health Act of 1970, the Solid Waste Disposal Act and the FDA prohibits retaliation against an employee who files a complaint with them. Federal workers are protected from losing their jobs.
►Whisteblowing is used as a last resort when all other methods for warning about a dangerous situation have failed.
• An estimated 50 million Americans are without healthcare
• Illness has been linked to 50 percent of all personal bankruptcies in the U.S. Often the person starts out owning a home and having health insurance, but once they get sick and can no longer work, they lose their health insurance and then their homes. With out a law to protect them, they may be denied new insurance because of their preexisting condition.
• Physicians no longer provide as much free care as they used to.
• Medical office personnel must treat all patients with the same consideration for the patient’s dignity no matter what their ability to pay.
• Another cause of rising medical cost is the physicians need to practice defensive medicine to avoid potential lawsuits.
• Rationing of medical resources to keep costs down but often makes patients unhappy
Patient Protection and Affordable Care Act
Health Reform 3590
The House passed H.R. 3590 on March 21, 2010 and was approved by the Senate on December 24, 2009. Major components include:
• A provision that allows individuals who already have healthcare coverage to retain their coverage if desired
• A provision also applies to employers who currently offer coverage.
• Patients who are not eligible under Medicare and Medicaid will be required to maintain minimum coverage beginning after 2013. There will be a fine for failing to retain coverage.
• A tax credit and reduced cost sharing, on a sliding scale, for qualified individuals.
• An expansion of Medicaid
• The act does not require employers to provide healthcare coverage, However, if they do not, they may be liable for an additional tax.
• Hospitals would be required to conduct periodic community health needs assessments.
predicting (without justification) that one step in a process will lead unavoidably to a second, generally undesirable step
Organs are given to patients who would benefit the most
All patients have an equal chance of receiving an organ.
Measures the medical need and medical benefit to determine organ allocation.
Unborn child in the stage of development between the second and twelfth week after conception.
Unborn child from the third month after conception to birth.
Time before birth during which the fetus is developing, usually around nine months (40 weeks).
The injection into the female’s vagina of seminal fluid that contains male sperm by some means other than sexual intercourse.
artificial insemination donor
A man who donates his semen for insemination of a woman who is not his wife.
artificial insemination husband
A procedure in which sperm from the woman’s husband or partner is used.
The process of combining ovum and sperm outside of a woman’s body.
A woman who agrees to bear a child for another couple. The husband’s sperm is implanted into the woman’s uterus.
preimplantation genetic diagnosis
Genetic testing on embryos for genes that cause untreatable or severe diseases.
Any action taken to prevent pregnancy from occurring.
The process of medically altering reproductive organs so as to terminate the ability to produce offspring.
Sterilization undertaken to save the mother’s life or protect her health.
eugenic (involuntary) sterilization
Sterilization of certain categories of persons, such as the insane, in order to prevent them from passing on defective genes to their children.
The science that studies methods for controlling certain characteristics in offspring.
Able to survive outside the uterus.
An abortion that occurs naturally without interference.
An abortion that is caused by artificial means such as medications or surgical procedures.
Unborn Victims of Violence Act
A law designed to provide legal penalties for any harm that is done to an unborn child at federal facilities such as military bases or in crimes that cross state lines.
Child Abuse Prevention and Treatment Act
(of 1987) Prohibited withholding of medical treatment solely because the infant is disabled.
The physician uses a needle to withdraw a small amount of amniotic fluid that surrounds the fetus, which is tested for the presence of genetic defects (e.g. Tay-Sachs disease and Down Syndrome).
Safe Haven Laws
Allows a parent to voluntarily give up custody of an infant thirty-one days or younger to a hospital ER, or police or fire station.
a person authorized to act for another
stiffness that occurs in death
body temperature below normal
stages of dying
Kubler-Ross; reflection on the dying process
legal definition of death
legal term for killing a patient