Intro To Surgical Technology: Legal Concepts

What should always be doubled checked on the consent form?

That the form is signed and the information on the form is correct.

What is the witness of a consent form verifying by signing a consent form?

• Identification of the patient • Voluntary patient signature w/o coercion • Mental state of the patient at the time of signing

What are some of the current Hospital National Patient Safety Goals?

• Identify patients correctly • Improve staff communication • Use medicines safely • Use alarms safely • Prevent infections • Identify patient risks • Prevent mistakes in surgery

Who can sign a consent form if the patient is mentally incompetent?

• Legal guardian who many be an individual or an agency • Court of jurisdiction can legalize procedure in absence of a legal guardian

Respondeat Superior

• Master-servant rule • If a patient is injured as a result of an employee's negligent act, the employer is responsible to the injured patient. • ie. Outdated methods exist at a hospital for labeling medications.

Res Ipsa Loquitor

"The thing speaks for itself.

Incident report

A written description of any event that caused harm or presented the risk if harm to a patient or staff in the normal course of health care. • For anything that is different from the norm. • States facts only.

Example of a sentinel event

Death of a patient

Libel

Defamation in writing.

What are the two types of tort law?

Intentional torts and Unintentional torts.

Statutory law

Passed by legislative bodies. ie. against physician assisted suicide.

Which types of laws affects the healthcare system and patient care process?

Constitutional law, Statutory law, Common law, and Administrative law.

What are the 3 principal components of The Universal Protocol?

1. Conducting a pre-procedure verification process. 2. Marking the procedure site. 3. Performing a "TIME OUT" immediately before starting the procedure.

What are the surgeon's responsibilities when obtaining consent?

1. Provide information in understandable language. 2. Use no coercion or intimidation. 3. Inform patient of proposed surgical procedure or treatment. 4. Inform patient of potential risks and/or complications. 5. Surgeon must inform patient of alternative therapies and other relative risks. 6. Explain procedure to patient or family member or both in understandable language.

What are the 3 things that must be true for the Res Ipsa Loquitor doctrine to be applied?

1. The injury would not have happened under normal circumstances. 2. The patient was under the care of the defendant at the time of the occurrence. 3. The injury would not have happened for any reason other than negligence of the defendant. ie. retained foreign body.

What are some patient questions that should be answered in order to obtain an informed consent?

1. What do you plan to do to me? 2. Why do you want to do this procedure? 3. Are there any alternatives to this plan? 4. What things should I worry about? 5. What are the greatest risks to me or the worst thing that could happen to me?

What are the 4 elements of an informed consent?

1. What the procedure is and how it will be performed. 2. The possible risk and results, as well as the expected results. 3. The alternative treatments or procedures with their risks. 4. The result if not treatment is given.

Libabilty Insurance

A contract in which the insurance company agrees to defend the policy holder if that individual is sued for acts covered by the policy. • Most facilities carry insurance that covers incidents that result in harm to a patient when policies and procedures are followed. *** • May not cover the employee who fails to follow the established protocol. • A caregiver may be named in the suit as an individual or codefendant • Professional associations recommend individual professional liability insurance and frequently offer discounts to members.

Subpoena

A court order requiring it's recipient to appear and testify at a trial or deposition. Medical records can also apply.

Ethics

Core values that define one's relationship with others. Group standards.

Medical ethics

A branch of ethics concerned with the practice of medicine.

What must the patient sign before the surgeon can perform any procedure(s)?

A consent form.

Defamation

A derogatory, false statement that is communicated to another and causes damage to a person's reputation.

Advance directive

A document in which a person gives instructions aboutm his or her medical care in the event they the individual cannot speak. Examples are a living will and a medical power of attorney.

Safe medical device act

A federal regulation that requires the reporting of any incident causing death or injury that is suspected to be the result of a medical device.

Dilemma

A situation or personal conflict that arises from a need to make a decision when none of the choices are acceptable.

Corporate Negligence

A health institution may be found negligent for failing to ensure that an acceptable level of patient care was provided. ie. maintenance and monitoring of employee skills. • prevention = Continuing Education credits

Medical / Durable Power of Attorney for Healthcare

A legal document signed be a person who is giving another individual the power to make health care decisions for the first person if he or she becomes incompetent, unconscious, or unable to make decisions for themselves.

Living will

A legal document stating the patients wishes regarding care in the event the patient is unable to speak for themselves.

Unretrieved device fragment

A portion of a medical device that has broken off or come apart in the body and is not detected or removed. Examples are fragments of a broken surgical needle and a hinge pin of a surgical instrument.

Timeout

A procedure in which the surgical team affirms the identity of the patient, correct procedure, and location (side), verification of informed consent, and other documents necessary to proceed with the surgery. Mandated by the Joint Commission.

Informed consent

A process and a legal document that states the patients surgical procedure and the risks, consequences and benefits of that procedure. Critical to perioperative patient care. • A patient is entitled to receive information on which to base a decision related to treatment. • Has legal value. • Provides evidence of a patient's agreement to allow procedure(s) to be performed.

Law

A rule of conduct or action established by custom or laid down and enforced by a governing authority. Societal standards.

Standards of conduct

A set of rules or guidelines an organization writes for its members. The rules pertain to how people behave and are based on the principles that the organization values, such as professionalism, and personal integrity.

Accountability

Accepting responsibility for one's actions.

Punitive

Actions intended to punish a person who has violated the law.

Criminal acts

Acts committed against society even if there is only one victim and may require imprisonment, fines or both. ie. robbery, murder, fraud, embezzlement, discrimination.

Civil acts

Acts committed by a party or an individual against another party or individual that are punishable by monetary damages. ie. acts between citizens and their governments, contract law, trusts and wills, tort law.

When is the patient asked to sign a consent form?

After making a decision to have surgery, usually one or more days prior to surgery and before any premedication is given.

Example of a sentinel event

An injury to the patient while that person is in the care of peri operative staff.

Assault

An intentional act that causes another person apprehension of being touched in an offensive manner or physical harm.

Retained foreign object

An item that is inadvertently left inside the patient during surgery.

Sentinel event

An unexpected incident resulting in serious physical injury, psychological harm, or death. The near miss of injury or harm is also considered a sentinel event. • Requires immediate investigation and response. • Evaluated for "root cause" • Plan for prevention should be developed

Negligence

Failure to do something that a reasonable person would do or the act of doing something that a reasonable and prudent person would not do.

Example of a sentinel event

Failure to obtain informed consent

Deviation

Ask the question: "Would a reasonable person in a similar situation have done the same thing as the person being sued?"

General Consent

Authorizes surgeon to render treatment or perform procedures as the surgeon deems advisable.

Example of a sentinel event

Break in sterile technique

Example of a sentinel event

Bullying

Morals

Personal standards

Example of a sentinel event

Cardiac or respiratory arrest

In an emergency situation, if 2 consulting physician's have been given all information concerning the patient, and their condition, they will ______________________.

Complete a written consultation until a relative can sign the consent form. THE SURGEON CANNOT BE ONE OF THE TWO PHYSICIANS!

Implied Consent

Consent given in which circumstances exist that would lead a reasonable health-care provider to believe that the person, or patient, had given consent although no direct or verbally expressed words of consent had been given. ie. If a surgeon finds something significant (and unexpected) during a surgery that requires immediate care. This condition may not have been covered specifically on the permit. Consent is implied in emergency situations.

The Universal Protocol

Created to address the continuing occurrence of wrong site, wrong procedure and wrong person surgery • Part of the JCAHO National Patient Safety Goals

Invasion of Privacy

Disclosure of private information concerning a patient or photographing a patient without consent.

Intentional Infliction of Emotional Distress

Disparaging remarks made about a patient that result in emotional distress.

Personal liability

Each person is responsible for his or her conduct. ie. performing skills outside of your scope of practice.

Example of a sentinel event

Equipment failure

Joint Commission on Accreditation of Healthcare Organization (JCAHO)

Establishes performance-based standards that focus on: 1. Actual clinical care provided directly to patients. 2. Management of the health care organization providing services. 3. Establishes Hospital National Patient Safety Goals every year.

Professional ethics

Ethical behavior established by authoritative peers of a particular professional, such as medicine or law.

False imprisonment

Illegal detention of a person without consent (use of restraints), or forcing a person to stay in an area by not allowing him/her to leave.

What are 3 types of consent?

General Consent, Special Consent and Implied Consent

Common law

Governs all areas not covered by statutory law. A jury or cour often decides. Also known as judicial law.

Public law

Governs the relationship between people and their government.

Private law

Governs the relationship between people.

Example of a sentinel event

Incorrect count

Intentional Torts

Intentional acts that are willful and violate the civil rights of a patient. ie. assault, battery, defamation, false imprisonment, intentional infliction of emotional distress, invasion of privacy

Who can sign a consent form?

Patient of legal age who is mental competent, or guardian, and 1 or more witnesses

Statutes

Laws passed by state legislative bodies.

Example of Negligence or Malpractice

Leaving a surgical sponge in a patient because of lax or incorrect counting procedures.

Tort law

Legal wrongdoing that results in injury to a person or property. Type of civil law commonly encountered in healthcare.

Liable

Legally responsible and accountable.

Example of a sentinel event

Loss of patient property

Example of a sentinel event

Medication error

Damages

Money awarded in a civil lawsuit to compensate the injured party.

What should a surgical technologist never do? aka. What is out of a surgical technologists scope of practice?

NEVER . . . • administer medications in any way • administer anesthetic agents • function in the OR suite without proper supervision of a qualified registered nurse or physician • clamp tissues, place sutures or alter body tissue in any way • obtain or administer blood • have final sign-off on OR documentation

Special Consent

Necessary for procedures in which experimental drugs, chemical agents, medical devices or new procedure will be used.

Example of Gross Negligence

Participating in a procedure under the influence of drugs or alcohol.

Types of OR documentation

Operative Report Informed Consent Form Incident Report Advanced Directive (includes Living Will, Durable Power of Attorney for Health Care, Durable Power of Attorney)

What directly impacts the care of the surgical patient?

Our conduct

Example of a sentinel event

Procedure done on the wrong patient

What kind of procedure is written consent necessary for?

Procedures that may be injurious to a patient.

Evidence-based practice

Professional practices and their standards based on established scientific research rather than opinion or tradition.

What is the purpose of a consent form?

Protects the patient, physician, surgical team members and the hospital.

Who can witness the consent form?

R.N., Physician other than the surgeon, other hospital employees, family members (1 or more witnesses required)

Gross-Negligence

Recklessness and wanton disregard for the standard of care and the interest of others.

Operative Report

Report of Surgery

Who must sign a consent form if the patient is unconscious?

Responsible relative, parent, or guardian

Example of False Imprisonment

Restraining a competent patient against his or her will while in the OR.

Hospital policy

Rules or regulations that hospital employees are required to follow. They are created to protect patients and employees from harm and to ensure smooth operation of the hospital.

Sexual harassment

Sexual coercion, sexual innuendoes, or unwanted sexual comments, gestures, or touch.

Example of a sentinel event

Sexual harassment

Never Event

Should never happen

Ethical dilemmas

Situations in which ethical choices involve conflicting values.

Slander

Spoken defamation.

Duty

Standard of conduct.

Practice acts

State laws that establish and regulate the conditions under which professionals may practice including licensure, registration, educational requirements, scope of duties, and functions.

Example of a sentinel event

Surgery performed on the wrong side

Example of Invasion of Privacy

Telling your spouse about your neighbor's surgery with out the patient's permission.

What are 2 types of healthcare policies and procedures?

The Patient Care Partnership HIPPA

Constitutional law

The U.S. Constitution is the supreme source of law for the nation. (Note: Each state has a constitution as well.)

Battery

The actual act of assault resulting in physical contact.

Delegation

The assignment of one's duties to another person. In medicine, the person who delegates a duty retains accountability for the action of the person to whom it is delegated.

Who's responsibility is it to check the patient's chart when a patient arrives in the surgical department?

The circulator and anesthesiologist.

Perjury

The crime of intentionally lying or falsifying information during court testimony after a person has sworm to tell the truth.

Who's responsibility is it to check the patients chart for a consigned consent form?

The person bringing the patient into the OR.

Deposition

The testimony of a witness given under oath and transcribed by a court reporter during the pretrial phase of a lawsuit.

What is the primary difference between criminal and civil law?

The type of punishments and legal implications.

Administrative laws

laws created by an agency or a department of the U.S. government. ie. EPA, DEA, OSHA

Malpractice

Type of negligence committed by a professional. Professional misconduct, improper discharge of professional duties or failure to meet the standard of care of a professional person.

Example of Defamation

While sitting in the hospital cafeteria, a CST states that a specific surgeon is incompetent.

How may an illiterate patient sign a consent form?

With an "X" after which the witness writes "patient's mark"

Example of Intentional Infliction of Emotional Distress

Yelling at a patient for not understanding your instructions.

The witness(es) assume no _________ or _____________ for the patient's understanding!

liability, responsibility

What are two types of defamation?

libel and slander

If the patient is an ______________, ___________, or _________________, he/she may sign their own consent form.

emancipated minor, married, independently earning a living

Primum Non Nocere doctrine

• "First, do no harm." • Not truly a legal doctrine but physicians are judged by this principle. • Written by Hippocrates and translated to Galen. • Observing this principle places the health and welfare of patients above everything else.

Types of Manuals

• Hospital Policy manual • Operating Room manual • Infection Control manual • Disaster Plan manual

Captain of the Ship doctrine

• "borrowed servant rule" • Most hospitals no longer recognize this doctrine. • Based on the theory that hospitals merely provided "workshops for physicians" • Hospitals were kept out of litigation because employees were "borrowed servants" and under the control of the surgeon, who was responsible for actions of all team members.

Foreseeability

• "should have recognized" • Proving cause in negligence. • For an individual or institution to be held liable, the risk of the injury has to be foreseeable. • ie. leaving the side rails down on the stretcher after transfer from the operating room bed, resulting in a patient fall.

How is consent obtained by telephone?

• 2 RNs should monitor the call & sign the form, which is later signed by the patient, legal guardian or responsible relative • The circulator should NOT be one of the two nurses signing the form

How is informed consent dealt with emergency situations?

• A hospital's policy will dictate procedure • Consent is desired but not essential • Saving a life takes precedence over obtaining and operative consent • Patient's state of consciousness may prevent ability to give a verbal consent

Examples of Never Events

• Air embolism • Blood incompatibility • Catheter associated urinary tract infection (MOST COMMON POST-OP INFECTION) • Poor control of blood sugar • Deep vein thrombosis or pulmonary emboli after total knee or total hip surgery • Falls or trauma while in care • Retained object in surgery (RSI - retained surgical item) • Pressure sores • Surgical site infection (SSI) after coronary bypass surgery • SSI after certain orthopedic or bariatric surgeries • Catheter-associated vascular (bloodborne) infection

How can you reduce the risk of torts?

• Ask questions. • Concentrate. • Be prepared emotionally and physically. • Know current practices. • Primum Non Nocere ("First, do no harm") • Aeger Primo

How can you prevent liability?

• Become active within professional organizations (ie. AST) • Remain current with continuing education • Establish positive rapport with patients • Comply with legal statutes of the state and standards of accrediting agencies (ARCSTSA) • Comply with health care facility policies • Document and "leave a paper trail" • Prevent injuries by adhering to policies and procedures • If an injury occurs, control further, report damages and take corrective action

What are the 4 factors that are considered when determining negligence?

• Duty • Deviation • Direct Cause • Damage. (All 4 must be present for a patient to recover damages during litigation.)

What do performance-based standards relate to?

• Efficiency • Effectiveness • Safety • Timeliness • Appropriateness • Continuity • Availability of care • Patient satisfaction

Hospital expectations stated in The Patient Care Partnership

• High quality hospital care • A clean and safe environment • Involvement in your care • Protection of your privacy • Help when leaving the hospital • Help with yo ur billing claims

Operating Room Incidents That Could Result in Litigation

• Misidentification of a patient (TIME OUT helps this.) • Incorrect procedure (TIME OUT helps this.) • Incorrect sponge, needle or instrument count • Burns, falls or injuries • Abandonment • Incorrect positioning • Improper care of specimens including loss or misidentification (Ask the surgeon how they would like it labeled!) • Incorrect drugs or incorrect administration • Use of defective equipment or instruments • Improper care of patient's property including loss or damage (hair, dentures ...) • Lack of informed consent • Major break in aseptic technique • Documentation errors •Failure to observe critical events and to take appropriate action • Exceeding authority or accepted functions • Assault and battery • Break of confidentiality • Invasion of privacy • Defamation

What are the required parts of a consent form?

• Patient's legal name in full. (Married woman's given name.) • Surgeon's legal name • Specific procedure(s) to be performed • Patient's legal signature • Signature of witness(es) (1 or more required) • Date and time of signatures

Who can sign a consent form if the patient is inebriated or impaired?

• Spouse • Responsible relative of legal age • Legal guardian can sign if there is not enough time for individual to regain sense.

Health Insurance Portability and Accountability Act

• Standards that address the security and privacy of health data • Many facilities require students/employees to sign a confidentiality agreement

The Patient Care Partnership

• States patient and hospital responsibilities. • Plain language brochure informs patients about what they should expect during their hospital stay with regard to their rights and responsibilities and is distributed to patients upon their admission to the hospital. • American Hospital Association

How can consent be obtained during emergency situations?

• Telephone • Telegram • Written communication: FAX, Email

Examples of Assault and Battery

• Threatening a patient with harm. • Operating on a patient without proper consent.

What role did the Centers for Medicare and Medicaid Services (CMS) play in regards to Never Events?

• Took action to improve patient care and decrease errors that result in serious harm or death. • CMS no longer reimburses the healthcare facility for care rendered to patients. This action is to remedy the consequences of errors

What are the anesthesiologist's responsibilities in regards to consent?

• Visit patient and/or family. • Discuss method of anesthesia to be used or recommended • Give the patient choices, if possible. (ie. general vs. spinal anesthetic) • Inform patient of potential risk and/or complications related to chosen anesthetic method

When is an informed consent required?

• for each surgical procedure to be performed • Any procedure in which general anesthesia is to be administered • Procedures involving entrance into a body cavity • Any hazardous therapy such as chemotherapy • when a patient is participating in experimentation of new drugs, chemical agents, medical devices, etc.