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Legal Concepts, Risk Management, & Ethical IssuesST210

Concorde Career College

Objectives

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

Objectives

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

Objectives

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

Objectives

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

Objectives:

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

Terms

Abandonment Accountability Affidavit Allegation Bona fide Case law Complaint Defendant Deposition Federal law Defamation

Guardian Iatrogenic injury Indictment Jury Larceny Statutory law Common law Liability Corporate liability Personal liability Malpractice

Terms

Negligence Criminal negligence Perjury Plaintiff Precedent Standard of care State law Subpoena Tort 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

Torts

A civil wrong not arising out of a contract or statute

Provides a remedy in the form of an action for damages.IntentionalUnintentional

OR staff: civil actions, not criminal

Torts

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

Torts 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

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 Patient Misidentification Misidentification

Incorrect procedureIncorrect procedure Foreign Bodies left Foreign Bodies left

in patientsin patients BurnsBurns PositioningPositioning Improper handling Improper handling

of specimensof specimens Drug errorsDrug errors

Defective Defective equipment or equipment or instrumentationinstrumentation

Loss of patient’s Loss of patient’s propertyproperty

Major breaks in Major breaks in sterile techniquesterile technique

Exceeding scope of Exceeding scope of practice or hospital practice or hospital policypolicy

AbandonmentAbandonment

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” 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” Verification Procedure: The RN is responsible to

complete and document on the Surgical/Invasive Procedure “Time-Out” Verification Checklist that 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:


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.


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


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


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)


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.


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 Patient’s name and date of birth Correct side/site, including marking, if Correct side/site, including marking, if

applicable applicable Correct procedure Correct procedure Correct patient position Correct patient position Correct radiograph data, if applicable Correct radiograph data, if applicable Special equipment/implants/requirements Special equipment/implants/requirements

available, if applicableavailable, 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”.

Consent

Consists of at least two parties – One being the recipient of the action; Second being 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?

Competent adult Parent of legal guardian of a minor Hospital administrator Courts

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

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

GeneralSigned on admission to the hospital Signed on admission to the hospital

for diagnostic procedures, medical for diagnostic procedures, medical treatment, and normal and routine treatment, and normal and routine “touching”“touching”

SpecialUsed for any procedure that entails Used for any procedure that entails

higher than normal riskshigher than normal risks

Written Informed Consent

Surgeon is responsible for securing a Surgeon is responsible for securing a “Written Informed Consent”“Written Informed Consent”

Conditions to be met:Conditions to be met:Must be in understandable language Must be in understandable language There can be no coercion or intimidation of There can be no coercion or intimidation of

the patientthe patientProcedure must be explained Procedure must be explained Potential complications, risks, and benefits Potential complications, risks, and benefits

must be explainedmust be explainedAlternative therapies must be explainedAlternative therapies must be explained

Written Informed Consent cont.

Proper written informed consent Proper written informed consent should contain the following:should contain the following:Patient’s legal namePatient’s legal nameSurgeon’s nameSurgeon’s nameProcedure (side)Procedure (side)Patient’s legal signaturePatient’s legal signatureSignature of witness(es)Signature of witness(es)Date and time of signaturesDate and time of signatures

Written Informed Consent cont. The The patientpatient usually gives consent usually gives consent If the patient is incapable of giving consent If the patient is incapable of giving consent

(physically unable or legally incompetent),(physically unable or legally incompetent), another properly authorized person must another properly authorized person must give consent. The same guidelines pertain give consent. The same guidelines pertain to this personto this person

The patient must be of legal age or legally The patient must be of legal age or legally declared emancipated minordeclared emancipated minor

The patient must be mentally alert and not The patient must be mentally alert and not under the influence of drugsunder the influence of drugs

Written Informed Consent cont. Consent may be given under the Consent may be given under the

following specific conditions:following specific conditions:A competent adult speaking for A competent adult speaking for

themselvesthemselvesParent or legal guardian of a minorParent or legal guardian of a minorGuardian in case of physical inability or Guardian in case of physical inability or

legal incompetencelegal incompetenceTemporary guardianTemporary guardianHospital AdministratorHospital AdministratorThe CourtsThe Courts


Any variance from normal procedure is Any variance from normal procedure is defined by hospital policy defined by hospital policy (example- (example- emergency)emergency)

Some variances may include:Some variances may include:TelephoneTelephoneTelegramTelegramAgreement of two consulting physicians (not Agreement of two consulting physicians (not

including the involved surgeon)including the involved surgeon)Administrative consentAdministrative consent


Witnesses are defined by hospital Witnesses are defined by hospital policy and may include:policy and may include:PhysicianPhysicianRNRNCSTCSTOther hospital employeeOther hospital employee

Implied Consent

Allowed in emergency situationsAllowed in emergency situations Not preferred by healthcare institutions Not preferred by healthcare institutions May apply during surgical procedures May apply during surgical procedures – –

example – the surgery extends beyond example – the surgery extends beyond the planned procedure; an unconscious the planned procedure; an unconscious patients are presumed to have patients are presumed to have consented to appropriate medical consented to appropriate medical treatmenttreatment

Consent

Once given, consent can be taken Once given, consent can be taken awayaway

Patients have a legal right to change Patients have a legal right to change their mindstheir minds

It only takes a verbal reconsiderationIt only takes a verbal reconsideration It should be well documentedIt should be well documented

Documentation

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

Patient’s Chart

Identification of the patientIdentification of the patient Identification of physician(s), nurse(s), and Identification of physician(s), nurse(s), and

other healthcare providers involved with other healthcare providers involved with carecare

H&PH&P DXDX Treatment planTreatment plan Medication recordMedication record Physical findings ex- lab workPhysical findings ex- lab work Discharge conditionDischarge condition Follow up treatment planFollow up treatment plan

Operative Record

Surgical team’s names and titlesSurgical team’s names and titles Patient’s condition before, during, and Patient’s condition before, during, and

after surgeryafter surgery Start and finish timeStart and finish time CountsCounts Details about the whole eventDetails about the whole event

Incident Reports

A mechanism for reporting any A mechanism for reporting any incidents that are related to adverse incidents that are related to adverse patient carepatient care

Used by surgical personnel to Used by surgical personnel to describe an unusual event that has describe an unusual event that has occurred that may have legal occurred that may have legal ramifications for the staff or patientramifications for the staff or patient

Advanced Directives

Written instruction dealing with the Written instruction dealing with the right of an incapacitated patient to right of an incapacitated patient to self-determinationself-determination

Examples:Examples:Living willLiving willMedical power of attorneyMedical power of attorney

Ethical and Moral Issues

Ethics: what is good for the individual what is good for the individual and for society and establishes the and for society and establishes the nature of duties that people owe nature of duties that people owe themselves and one another.themselves and one another.

Attempts to define the concepts of Attempts to define the concepts of character and customs and their character and customs and their relationship to beliefs, morals, and relationship to beliefs, morals, and personal values.personal values.

Moral Principles

Defined as the guides for ethical Defined as the guides for ethical decision making, and the principle we decision making, and the principle we try to instill in our children.try to instill in our children.

Include the concern that we have for Include the concern that we have for the well-being of others and respect the well-being of others and respect for their autonomy.for their autonomy.

Bioethics

The study of the ethical implication of The study of the ethical implication of biological research and applications, biological research and applications, especially in medicine.especially in medicine.

The focus is to maximize total human The focus is to maximize total human benefits.benefits.

Patient’s Bill of Rights

Adopted in 1972 and revised in 1992Adopted in 1972 and revised in 1992

Makes several assumptions that cover Makes several assumptions that cover the scope of a patient’s carethe scope of a patient’s care

A copy is given to every patient upon A copy is given to every patient upon checking in to the hospital or clinicchecking in to the hospital or clinic

Summary Patient’s Bill of Rights

Health care is a collaborationHealth care is a collaboration Open and honest communicationOpen and honest communication Mutual respectMutual respect Must be sensitive to cultural, racial, Must be sensitive to cultural, racial,

linguistic, religious, age, gender, and linguistic, religious, age, gender, and other differences, including disabilitiesother differences, including disabilities

Patient’s Bill of Rights

Receive considerate and respectful careReceive considerate and respectful care Obtain relevant, current, and Obtain relevant, current, and

understandable information concerning understandable information concerning their care or treatmenttheir care or treatment

Make decisions about care received Make decisions about care received before and during treatmentbefore and during treatment

Prepare an advance directivePrepare an advance directive Expect privacyExpect privacy

Patient’s Rights, cont’d

Expect that all private information will Expect that all private information will remain privateremain private

Review records concerning medical careReview records concerning medical care Consent or decline to participate in Consent or decline to participate in

research studiesresearch studies Expect reasonable continuity of careExpect reasonable continuity of care Be informed of hospital policies and Be informed of hospital policies and

practicespractices

Issues That Affect the ST

Elective sterilizationElective sterilization Fertilization proceduresFertilization procedures Elective abortionElective abortion Human experimentationHuman experimentation Animal experimentationAnimal experimentation Organ donation/transplantationOrgan donation/transplantation Quality vs. quantity of lifeQuality vs. quantity of life Gender reassignmentGender reassignment

Professional Codes of Conduct

The AST established a code of ethics The AST established a code of ethics for the ST in 1985for the ST in 1985

Failure to adhere to this code may Failure to adhere to this code may result in expulsion from the professionresult in expulsion from the profession

Code of Ethics

To maintain the highest standards of To maintain the highest standards of professional conduct and patient care.professional conduct and patient care.

To hold in confidence, with respect to the To hold in confidence, with respect to the patient’s beliefs, all personal matters.patient’s beliefs, all personal matters.

To respect and protect the patient’s legal To respect and protect the patient’s legal and moral rights to quality patient care.and moral rights to quality patient care.

To not knowingly cause injury or any To not knowingly cause injury or any injustice to those entrusted to our careinjustice to those entrusted to our care.

Code of Ethics, cont’d

To work with fellow surgical technologists To work with fellow surgical technologists and other professional health groups to and other professional health groups to promote harmony and unity for better promote harmony and unity for better patient care.patient care.

To always follow the principles of asepsis.To always follow the principles of asepsis. To maintain a high degree of efficiency To maintain a high degree of efficiency

through continuing education.through continuing education. To maintain and practice surgical To maintain and practice surgical

technology willingly, with pride and dignitytechnology willingly, with pride and dignity..

Code of Ethics, cont’d

To report any unethical conduct or To report any unethical conduct or practice to the proper authority.practice to the proper authority.

To adhere to the Code of Ethics at all To adhere to the Code of Ethics at all times with all members of the health times with all members of the health care team.care team.

Surgical Conscience

Allows the ST to keep a patient’s Allows the ST to keep a patient’s confidence, avoid discrimination confidence, avoid discrimination against any patient based on the against any patient based on the technologist’s technologist’s PERSONALPERSONAL values, values, and be committed to cost control.and be committed to cost control.

Must have the personal moral Must have the personal moral authority to accept responsibility for authority to accept responsibility for his/her own actions.his/her own actions.

Surgical Conscience

Must be committed to maintaining the Must be committed to maintaining the confidentiality of information associated with confidentiality of information associated with patient care.patient care.

Dictates a nondiscriminatory treatment of all Dictates a nondiscriminatory treatment of all patients.patients.

Personal values, feelings, and principles take Personal values, feelings, and principles take a secondary position to the needs of the a secondary position to the needs of the patient.patient.

Surgical Conscience

Be committed to cost control. Medical care is Be committed to cost control. Medical care is expensive, so the ST must do their part to expensive, so the ST must do their part to keep cost under control.keep cost under control.

Be a guarantor of sterile technique in the OR.Be a guarantor of sterile technique in the OR.

Honesty, patient confidentiality, Honesty, patient confidentiality, nondiscriminatory treatment, cost nondiscriminatory treatment, cost consciousness, and sterile techniqueconsciousness, and sterile technique..

Scope of Practice

Identifies the disciplines and processes Identifies the disciplines and processes that define the field and the ways in that define the field and the ways in which surgical technology is different which surgical technology is different from other allied health fields.from other allied health fields.

Refers to our core accountabilities for Refers to our core accountabilities for which the provider has adequate which the provider has adequate education, experience, credentialing, education, experience, credentialing, etc.etc.

Scope of Practice

Was the skill taught in the ST program?Was the skill taught in the ST program? If not, have you since completed a program If not, have you since completed a program

that included clinical experience?that included clinical experience? Is the task routine in surgical technology?Is the task routine in surgical technology? Is the task prohibited by hospital policy or Is the task prohibited by hospital policy or

state law? Does it require a license?state law? Does it require a license? Is this practice within an acceptable Is this practice within an acceptable

standard of care?standard of care?

Scope of Practice

To a large extent, the scope of practice To a large extent, the scope of practice for a surgical technologist is for a surgical technologist is determined by the delegatory decisions determined by the delegatory decisions made by the supervising surgeon.made by the supervising surgeon.

How does this relate to Surgical First How does this relate to Surgical First Assistant skills and functions?Assistant skills and functions?STs may perform second assisting STs may perform second assisting

taskstasks

Job Descriptions

Descriptions of the tasks, functions, Descriptions of the tasks, functions, and responsibilities of a position within and responsibilities of a position within an organization.an organization.

RoleRole: : the set of responsibilities or the set of responsibilities or expected results associated with a expected results associated with a job.job.

JobJob: : usually includes several roles.usually includes several roles.

Credentialing

Does not verify competency. Competency Does not verify competency. Competency is an ongoing evaluation.is an ongoing evaluation.

Certification is recognition by an appropriate Certification is recognition by an appropriate body that an individual has met a body that an individual has met a predetermined standard.predetermined standard.

Licensure is the legal right granted by a Licensure is the legal right granted by a government agency in compliance with a government agency in compliance with a statute that authorizes and oversees the statute that authorizes and oversees the activities of a profession.activities of a profession.

Accreditation

CAAHEP accredits most ST programsCAAHEP accredits most ST programs

Accreditation is a process of external Accreditation is a process of external quality review used by higher quality review used by higher education to scrutinize colleges, education to scrutinize colleges, universities, and educational universities, and educational programs for quality assurance and programs for quality assurance and quality improvement.quality improvement.

Core Curriculum

Documents designed by educators Documents designed by educators that sets a specific standard for that sets a specific standard for curriculum developmentcurriculum development

A template for instructionA template for instruction

Clinical Ladder Programs

Allow an ST to ascend to positions of Allow an ST to ascend to positions of increased responsibility within an increased responsibility within an organization.organization.

Allows the ST to become more Allows the ST to become more directly involved in decision making, directly involved in decision making, broadening the role for proper surgical broadening the role for proper surgical patient care.patient care.

Risk Management Department

Legal Considerations

Purpose:

Enhance safety Minimize liability



Functions:

Prevention Monitoring Control



Methods:

Detection Evaluation Prevention

Errors in the Surgical Environment


Patient misidentification Incorrect procedure/location Burn Fall Positioning injury Abandonment

Surgical Burn

Cuatery Skin Burn



Specimen loss/misidentification Medication error Defective equipment/instrument Property loss/damage Lack of informed consent Documentation error



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

Retained Instruments

Errors in the Surgical Environment The ST can help avoid medical errors by:The ST can help avoid medical errors by:

Following written policies and proceduresFollowing written policies and procedures Obeying standard precautionsObeying standard precautions Be aware of the location and proper use of Be aware of the location and proper use of

all emergency equipmentall emergency equipment Professional development/continuing Professional development/continuing

education programseducation programs Report unsafe conditionsReport unsafe conditions Report injuries to staff or patientsReport injuries to staff or patients

Malpractice Insurance

Hospital employees are typically covered by Hospital employees are typically covered by insurance policies provided by the facility, as insurance policies provided by the facility, as long as the act was committed within the long as the act was committed within the scope of the institution’s policies and scope of the institution’s policies and procedures. However, a suit may be filed procedures. However, a suit may be filed against the employee by the facility in order to against the employee by the facility in order to recuperate legal costs in certain situations.recuperate legal costs in certain situations.

Extra insurance should be carried by the ST!

http://surgicalassistantresource.org/web_documents/liability_insurance_report.pdf

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:DeathSerious InjuryIllnessOther adverse experiences