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Legal Concepts, Risk Management, & Ethical Issues. ST210 Concorde Career College. Objectives. Identify and develop group behaviors appropriate to the educational process and the work environment including an awareness of cultural perspectives

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  • Identify and develop group behaviors appropriate to the educational process and the work environment including an awareness of cultural perspectives
  • Identify and develop leadership and problem solving skills that apply to the educational process and the work environment
  • Identify and develop team building and networking skills that apply to the educational process and the work environment.
  • Identify affective behaviors and integrate positive examples into professional practice
  • Analyze the critical thinking process and apply critical thinking skills to the educational process and surgical case management
  • Evaluate positive employability characteristics and begin to develop those qualities
  • Develop an education to employment strategy that includes employment trends and opportunities for the surgical technologist
  • Analyze the Patient’s Bill of Rights (American Hospital Association – AHA) as it pertains to the surgical patient

Identify ethical situations that healthcare workers may face and apply the principles of moral problem solving to ethical decision making

Understand basic legal terminology and apply major legal concepts to the responsibilities of surgical case management

Understand the legal risks and responsibilities of the surgical team members and the consequences that may apply when those responsibilities are not met

self management
Self Management


  • Describe the role of the risk management department of the healthcare facility
  • Identify errors that may occur in the surgical environment and list methods for prevention
  • List the benefits of professional liability coverage




Bona fide

Case law




Federal law



Iatrogenic injury




Statutory law

Common law


Corporate liability

Personal liability



Criminal negligence




Standard of care

State law



Aeger Primo

Tort Law

Patient’s Bill of Rights

Doctrine of borrowed servant

Doctrine of corporate negligence

Doctrine of foreseeability

Doctrine of personal liability

Doctrine of the reasonably prudent person

Primum non nocere

Res ipsa loquitur

Respondeat superior

  • A civil wrong not arising out of a contract or statute
  • Provides a remedy in the form of an action for damages.
    • Intentional
    • Unintentional
  • OR staff: civil actions, not criminal
  • Intentional –
    • Assault
    • Battery
    • Defamation
    • False imprisonment
    • Intentional infliction of emotional distress
    • Invasion of privacy
    • Intentional infliction of emotional distress
  • Requires proof of the willful action of three elements
  • Unintentional
    • Malpractice – the term used to describe the behavior of a professional person’s wrongful conduct
    • Negligence– a breach of duty– omission or commission of an act that a reasonable and prudent individual would do under the same conditions
      • Departure from the standard of care– the defendant had a duty to the plaintiff; that duty was breached by failing to confirm to the required standard of conduct.
unintentional tort negligence malpractice
Unintentional Tort- Negligence - Malpractice
  • If an individual engages in an activity requiring special skills, education, or experience (like working in an OR), the standard by which their conduct is measured is the conduct of a reasonably skilled, competent and experienced person who is a qualified member of the group authorized to engage in that activity
o r incidents
Patient Misidentification

Incorrect procedure

Foreign Bodies left in patients



Improper handling of specimens

Drug errors

Defective equipment or instrumentation

Loss of patient’s property

Major breaks in sterile technique

Exceeding scope of practice or hospital policy


O.R. Incidents
universal protocol surgical invasive procedure time out verification
Universal Protocol: Surgical/Invasive Procedure “Time-Out” Verification
  • Purpose:To promote patient safety and prevent risk of wrong site, wrong procedure, wrong person surgery, this policy defines the Universal Protocol requirements for patient identification verification and the “Time-Out” procedure to be conducted before any invasive or surgical procedure that exposes patients to more than minimal risk, including procedures done in settings other than the operating room.
universal protocol surgical invasive procedure time out verification1
Universal Protocol: Surgical/Invasive Procedure “Time-Out” Verification
  • Policy:Patient identification verification and conducting a “Time-Out” is required prior to all invasive/surgical procedures that involve puncture or incision of the skin, or insertion of an instrument or a foreign material into the body.
universal protocol surgical invasive procedure time out verification2
Universal Protocol: Surgical/Invasive Procedure “Time-Out” Verification
  • Procedure:The RN is responsible to complete and document on the Surgical/Invasive Procedure “Time-Out” Verification Checklistthat verification of patient identification and the required elements of the “Time-Out” have been conducted immediately prior to the invasive or surgical procedure according to the following guidelines:
universal protocol surgical invasive procedure time out verification3
Universal Protocol: Surgical/Invasive Procedure “Time-Out” Verification
  • Surgical/Invasive Procedures Included:Surgical/invasive procedures falling within the scope of these guidelines include, but are not limited to: biopsies, percutaneous aspirations, cardioversions, cardiac and vascular catheterizations, pericardiocentesis, Trans-esophageal echos, endoscopies, thoracentesis, chest tube insertions, paracentesis, lumbar punctures, bone marrow aspirations, closed reductions or manipulations of extremities, circumcisions, incisions and drainage of wounds, etc.
universal protocol surgical invasive procedure time out verification4
Universal Protocol: Surgical/Invasive Procedure “Time-Out” Verification
  • Initial Patient Identification Verification:The RN assigned to the care of the patient is to verify patient identification elements as listed on the Surgical/Invasive Procedure “Time-Out” Checklist prior to any invasive or surgical procedure
universal protocol surgical invasive procedure time out verification5
Universal Protocol: Surgical/Invasive Procedure “Time-Out” Verification
  • Re-verification of Patient Identification:Re-verification of identification elements is required if the patient is relocated to a different setting or staff changes occur prior to the invasive/surgical “Time-Out”; the RN assuming the care of the patient must re-verify the patient identification
universal protocol surgical invasive procedure time out verification6
Universal Protocol: Surgical/Invasive Procedure “Time-Out” Verification
  • Site Marking Requirements:Marking of the site immediately prior to the procedure is required for procedures involving left/right distinction, multiple structures (such as fingers, toes, kidneys), or multiple levels (as in spinal procedures)
universal protocol surgical invasive procedure time out verification7
Universal Protocol: Surgical/Invasive Procedure “Time-Out” Verification
  • Site Marking Exemptions:Site marking is not required for single organ cases or interventional procedures for which the insertion site is not predetermined. Also exempt are cases in which the physician performing the procedure is in continuous attendance with the patient from the time of the decision to do the procedure (consent is obtained from the patient) through the performance of the procedure. For those procedures in which site marking is not required, the other requirements for patient identification verification and “Time-Out” still apply.
universal protocol surgical invasive procedure time out verification8
Universal Protocol: Surgical/Invasive Procedure “Time-Out” Verification
  • Emergency Situations:In most cases, when invasive procedures are performed under emergency or urgent conditions, the physician performing the procedure will be in continuous attendance of the patient from the point of decision to do the procedure. Under those circumstances, marking the site would not be necessary, although the “Time-Out” to verify correct patient, procedure, and site would still be appropriate (unless it is such an emergency that even the “Time-Out” would add more risk than benefit).
“Time-Out” Procedure:A “Time-Out” procedure must be conducted in the location where the procedure will be performed, immediately before the start of any invasive procedure or surgical incision. The “Time-Out” procedure will be initiated by the RN and requires the active participation of all team members involved in the procedure to verify each of the following elements:

Patient’s name and date of birth

Correct side/site, including marking, if applicable

Correct procedure

Correct patient position

Correct radiograph data, if applicable

Special equipment/implants/requirements available, if applicable

The “Time-Out Procedure” is to be conducted in a “fail-safe” mode; the surgical/invasive procedure is not started until any questions/issues are resolved.

Required “Time-Out” Documentation: The RN is responsible to initiate and document the “Time-Out” procedure. The RN is to document the required elements of the “Time-Out” procedure by initialing in the spaces provided by each element of the “Time-Out”, writing in the names of all team members participating in the “Time-Out”, and signing on the signature line designated “RN Signature completing “Time-Out” Checklist”.

  • Consists of at least two parties – Onebeing the recipient of the action; Secondbeing the one to perform the action.
  • Voluntary and informed act in which one party gives permission to the other party to “touch” – Battery: nonconsensual touching
  • Surgical procedures require an Informed Consent (certain situations do not)
who can give consent
Who Can Give Consent?
  • Competent adult
  • Parent of legal guardian of a minor
  • Hospital administrator
  • Courts
consent cont
Consent cont.
  • Two formats for Consent
    • Express– direct verbal or written permission (preferred by healthcare facilities in written form)
    • Implied – manifested by action or inaction of silence, which presumes consent has been given
informed consent
Informed consent
  • The Joint Commission’s definition – agreement or permission accompanied by full notice about what is being consented to; the requirement that a patient be apprised of the nature and risks of a medical procedure before a healthcare professional can validly claim exemption from liability for battery or from responsibility for complications or undesirable outcomes
two categories of consent used in hospitals
Two Categories of Consent used in Hospitals
  • General
    • Signed on admission to the hospital for diagnostic procedures, medical treatment, and normal and routine “touching”
  • Special
    • Used for any procedure that entails higher than normal risks
written informed consent
Written Informed Consent
  • Surgeon is responsible for securing a “Written Informed Consent”
  • Conditions to be met:
    • Must be in understandable language
    • There can be no coercion or intimidation of the patient
    • Procedure must be explained
    • Potential complications, risks, and benefits must be explained
    • Alternative therapies must be explained
written informed consent cont
Written Informed Consent cont.
  • Proper written informed consent should contain the following:
    • Patient’s legal name
    • Surgeon’s name
    • Procedure (side)
    • Patient’s legal signature
    • Signature of witness(es)
    • Date and time of signatures
written informed consent cont1
Written Informed Consent cont.
  • The patient usually gives consent
  • If the patient is incapable of giving consent (physically unable or legally incompetent), another properly authorized person must give consent. The same guidelines pertain to this person
  • The patient must be of legal age or legally declared emancipated minor
  • The patient must be mentally alert and not under the influence of drugs
written informed consent cont2
Written Informed Consent cont.
  • Consent may be given under the following specific conditions:
    • A competent adult speaking for themselves
    • Parent or legal guardian of a minor
    • Guardian in case of physical inability or legal incompetence
    • Temporary guardian
    • Hospital Administrator
    • The Courts
written informed consent cont3
Written Informed Consent cont.
  • Any variance from normal procedure is defined by hospital policy (example- emergency)
  • Some variances may include:
    • Telephone
    • Telegram
    • Agreement of two consulting physicians (not including the involved surgeon)
    • Administrative consent
written informed consent cont4
Written Informed Consent cont.
  • Witnesses are defined by hospital policy and may include:
    • Physician
    • RN
    • CST
    • Other hospital employee
implied consent
Implied Consent
  • Allowed in emergency situations
  • Not preferred by healthcare institutions
  • May apply during surgical procedures – example – the surgery extends beyond the planned procedure; an unconscious patients are presumed to have consented to appropriate medical treatment
  • Once given, consent can be taken away
  • Patients have a legal right to change their minds
  • It only takes a verbal reconsideration
  • It should be well documented

~If you didn’t document it, you didn’t do it.~

patient s chart
Patient’s Chart
  • Identification of the patient
  • Identification of physician(s), nurse(s), and other healthcare providers involved with care
  • H&P
  • DX
  • Treatment plan
  • Medication record
  • Physical findings ex- lab work
  • Discharge condition
  • Follow up treatment plan
operative record
Operative Record
  • Surgical team’s names and titles
  • Patient’s condition before, during, and after surgery
  • Start and finish time
  • Counts
  • Details about the whole event
incident reports
Incident Reports
  • A mechanism for reporting any incidents that are related to adverse patient care
  • Used by surgical personnel to describe an unusual event that has occurred that may have legal ramifications for the staff or patient
advanced directives
Advanced Directives
  • Written instruction dealing with the right of an incapacitated patient to self-determination
  • Examples:
    • Living will
    • Medical power of attorney
ethical and moral issues
Ethical and Moral Issues
  • Ethics: what is good for the individual and for society and establishes the nature of duties that people owe themselves and one another.
  • Attempts to define the concepts of character and customs and their relationship to beliefs, morals, and personal values.
moral principles
Moral Principles
  • Defined as the guides for ethical decision making, and the principle we try to instill in our children.
  • Include the concern that we have for the well-being of others and respect for their autonomy.
  • The study of the ethical implication of biological research and applications, especially in medicine.
  • The focus is to maximize total human benefits.
patient s bill of rights
Patient’s Bill of Rights
  • Adopted in 1972 and revised in 1992
  • Makes several assumptions that cover the scope of a patient’s care
  • A copy is given to every patient upon checking in to the hospital or clinic
summary patient s bill of rights
Summary Patient’s Bill of Rights
  • Health care is a collaboration
  • Open and honest communication
  • Mutual respect
  • Must be sensitive to cultural, racial, linguistic, religious, age, gender, and other differences, including disabilities
patient s bill of rights1
Patient’s Bill of Rights
  • Receive considerate and respectful care
  • Obtain relevant, current, and understandable information concerning their care or treatment
  • Make decisions about care received before and during treatment
  • Prepare an advance directive
  • Expect privacy
patient s rights cont d
Patient’s Rights, cont’d
  • Expect that all private information will remain private
  • Review records concerning medical care
  • Consent or decline to participate in research studies
  • Expect reasonable continuity of care
  • Be informed of hospital policies and practices
issues that affect the st
Issues That Affect the ST
  • Elective sterilization
  • Fertilization procedures
  • Elective abortion
  • Human experimentation
  • Animal experimentation
  • Organ donation/transplantation
  • Quality vs. quantity of life
  • Gender reassignment
professional codes of conduct
Professional Codes of Conduct
  • The AST established a code of ethics for the ST in 1985
  • Failure to adhere to this code may result in expulsion from the profession
code of ethics
Code of Ethics
  • To maintain the highest standards of professional conduct and patient care.
  • To hold in confidence, with respect to the patient’s beliefs, all personal matters.
  • To respect and protect the patient’s legal and moral rights to quality patient care.
  • To not knowingly cause injury or any injustice to those entrusted to our care.
code of ethics cont d
Code of Ethics, cont’d
  • To work with fellow surgical technologists and other professional health groups to promote harmony and unity for better patient care.
  • To always follow the principles of asepsis.
  • To maintain a high degree of efficiency through continuing education.
  • To maintain and practice surgical technology willingly, with pride and dignity.
code of ethics cont d1
Code of Ethics, cont’d
  • To report any unethical conduct or practice to the proper authority.
  • To adhere to the Code of Ethics at all times with all members of the health care team.
surgical conscience
Surgical Conscience
  • Allows the ST to keep a patient’s confidence, avoid discrimination against any patient based on the technologist’s PERSONALvalues, and be committed to cost control.
  • Must have the personal moral authority to accept responsibility for his/her own actions.
surgical conscience1
Surgical Conscience
  • Must be committed to maintaining the confidentiality of information associated with patient care.
  • Dictates a nondiscriminatory treatment of all patients.
  • Personal values, feelings, and principles take a secondary position to the needs of the patient.
surgical conscience2
Surgical Conscience
  • Be committed to cost control. Medical care is expensive, so the ST must do their part to keep cost under control.
  • Be a guarantor of sterile technique in the OR.
  • Honesty, patient confidentiality, nondiscriminatory treatment, cost consciousness, and sterile technique.
scope of practice
Scope of Practice
  • Identifies the disciplines and processes that define the field and the ways in which surgical technology is different from other allied health fields.
  • Refers to our core accountabilities for which the provider has adequate education, experience, credentialing, etc.
scope of practice1
Scope of Practice
  • Was the skill taught in the ST program?
  • If not, have you since completed a program that included clinical experience?
  • Is the task routine in surgical technology?
  • Is the task prohibited by hospital policy or state law? Does it require a license?
  • Is this practice within an acceptable standard of care?
scope of practice2
Scope of Practice
  • To a large extent, the scope of practice for a surgical technologist is determined by the delegatory decisions made by the supervising surgeon.
  • How does this relate to Surgical First Assistant skills and functions?
    • STs may perform second assisting tasks
job descriptions
Job Descriptions
  • Descriptions of the tasks, functions, and responsibilities of a position within an organization.
  • Role: the set of responsibilities or expected results associated with a job.
  • Job: usually includes several roles.
  • Does not verify competency. Competency is an ongoing evaluation.
  • Certification is recognition by an appropriate body that an individual has met a predetermined standard.
  • Licensure is the legal right granted by a government agency in compliance with a statute that authorizes and oversees the activities of a profession.
  • CAAHEP accredits most ST programs
  • Accreditation is a process of external quality review used by higher education to scrutinize colleges, universities, and educational programs for quality assurance and quality improvement.
core curriculum
Core Curriculum
  • Documents designed by educators that sets a specific standard for curriculum development
  • A template for instruction
clinical ladder programs
Clinical Ladder Programs
  • Allow an ST to ascend to positions of increased responsibility within an organization.
  • Allows the ST to become more directly involved in decision making, broadening the role for proper surgical patient care.
risk management department
Risk Management Department

Legal Considerations


  • Enhance safety
  • Minimize liability
risk management department1
Risk Management Department

Legal Considerations


  • Prevention
  • Monitoring
  • Control
risk management department2
Risk Management Department

Legal Considerations


  • Detection
  • Evaluation
  • Prevention
errors in the surgical environment
Errors in the Surgical Environment

Legal Considerations

  • Patient misidentification
  • Incorrect procedure/location
  • Burn
  • Fall
  • Positioning injury
  • Abandonment
errors in the surgical environment1
Errors in the Surgical Environment

Legal Considerations

  • Specimen loss/misidentification
  • Medication error
  • Defective equipment/instrument
  • Property loss/damage
  • Lack of informed consent
  • Documentation error
errors in the surgical environment2
Errors in the Surgical Environment

Legal Considerations

  • Breach of sterile technique
  • Exceeding scope of practice
  • Violation of facility policy
  • Failure to observe a critical event AND take appropriate action
  • Retained foreign body
errors in the surgical environment3
Errors in the Surgical Environment
  • The ST can help avoid medical errors by:
    • Following written policies and procedures
    • Obeying standard precautions
    • Be aware of the location and proper use of all emergency equipment
    • Professional development/continuing education programs
    • Report unsafe conditions
    • Report injuries to staff or patients
malpractice insurance
Malpractice Insurance
  • Hospital employees are typically covered by insurance policies provided by the facility, as long as the act was committed within the scope of the institution’s policies and procedures. However, a suit may be filed against the employee by the facility in order to recuperate legal costs in certain situations.
  • Extra insurance should be carried by the ST!
safe medical device act
Safe Medical Device Act
  • Effective November 1990
  • Medical device users must report incidents to the manufacturer and the FDA that a medical device caused or contributed to:
    • Death
    • Serious Injury
    • Illness
    • Other adverse experiences