Legal, Ethical, and Professional Practice

Informed Consent and Site Marking

Informed Consent: Definition

• Informed consent represents the mutual understanding between the physician and the patient regarding the proposed surgical procedure.
• Key Principle: Only the physician can provide informed consent, explain the procedure, or clarify details about it. The nurse’s role is distinct.

Nurse’s Role in Consent Signing

• Order Verification: The nurse confirms the physician’s order for consent.
• Documentation: The nurse types/prints the consent form precisely according to the order, avoiding abbreviations.
• Patient Engagement: The nurse presents the form to the patient and asks: “Has the doctor discussed your surgery with you?” and “Do you have any questions?”
• Verification: The nurse states, “The consent form says _______, if you agree, please sign here _______.”
• Physician Signature: The physician is not required to sign the consent form.

Site Marking Protocol

• Timing: The surgical site is marked outside of the OR.
• Consistency: A consistent marking method is used throughout the hospital.
• Patient Participation: The patient actively participates in the marking process and must NOT be sedated. (Whoever signs the consent form participates in site marking).
• Signatory: The site is marked by the surgeon or a “medical person” (e.g., resident) who will be physically present and participate in the surgery.

Surgical Safety Protocols: Site Marking and Time Out

Ensuring correct patient, procedure, and site is paramount in surgery.

Individuals Authorized to Participate in Site Marking

The responsibility for accurate site marking involves key personnel:

• The patient (or their legal representative who signed the consent form).
• The operating physician.
• An authorized medical professional (e.g., resident) who will be actively involved in the surgical procedure within the operating room.

Optimal Timing for Completing a Time Out

• The ideal moment to conduct a Time Out is prior to the administration of anesthesia, allowing the patient to actively hear and confirm the details.

Conducting a Time Out

• Timing Flexibility: While ideally performed pre-anesthesia with patient awareness, it can also be done after draping and before the incision.
• Designated Lead: A designated individual, typically a nurse, leads the Time Out process according to institutional policy.
• Comprehensive Review: It must encompass:
  • Confirmation of radiation use (if applicable).
  • Assessment of fire risk.
  • Verification of antibiotic administration.
• Affirmation: The Time Out concludes with a clear acknowledgment from all participants (“I agree”).
• Discrepancy Resolution: A defined protocol must exist to resolve any disagreements that arise during the Time Out.

Requirement for Multiple Time Outs

Separate Time Outs are mandatory in specific scenarios:

• When there is a change in the primary operating physician, unless both physicians are present and collaborating on the case from beginning to end.
• If the patient requires redraping for a subsequent procedure.

Case Study: Dr. Mendella and Dr. Wilson

• Scenario: Dr. Mendella performs an ankle ORIF, followed by Dr. Wilson performing a toe amputation. Both will assist each other throughout.
• Time Outs Required: One (since both surgeons are present and involved from start to finish).

Case Study: Dr. Mendella with Redraping

• Scenario: Dr. Mendella performs an ankle ORIF, then redrapes the patient for a TFN (Tibial Nailing).
• Time Outs Required: Two (due to the redraping).

Informed Consent: Competency and Legalities

Informed consent ensures patient autonomy and legal protection.

Using Next of Kin for Consent (When No Power of Attorney)

• Prerequisites: This can only occur after the physician explicitly documents in the Physician Staff Notes:
  • The patient is not currently competent.
  • The patient will not regain competency in time to delay surgery.
• Hierarchy: The spouse is typically the first priority. Subsequent priorities (parents, children) are determined by state-specific laws and may involve a “gray area.”

Definition of “Next of Kin” for Consent

• Primary: The spouse holds the highest priority.
• Subsequent: Other relationships (parents, children) are prioritized based on individual state statutes.
• Due Diligence: A good faith effort must be made to locate the direct next of kin, but state laws vary in defining this.

Elements Constituting Valid Informed Consent

For consent to be legally valid, all the following must be true:

• The patient possesses knowledge of the procedure.
• The patient comprehends the potential complications associated with the surgery.
• The patient understands the available alternatives to surgery, including choosing “something” or “nothing.”
• The patient is competent to provide consent. This must be explicitly documented in the Physician’s Staff Notes if the patient is not competent and will not regain competency to delay surgery.
• The patient desires the procedure.

When a Patient’s Signature on Consent is Legally Invalid

• A patient’s signature on a consent form is no longer legally binding if signed before the full half-life of any administered narcotic has elapsed.
• Example: If a drug has a half-life of 2 hours, the patient must sign at least 2 hours after the drug was given.

Case Study: Narcotic Half-Life and Consent

• Scenario: Patient received a narcotic at 13:00 with a 4-hour half-life. The patient needs to sign consent at 16:00.
• Legally Binding? No. The signature is only legally binding after the narcotic’s full half-life has passed.

Nurse’s Responsibilities Regarding Informed Consent

The nurse’s role in the consent process is to:

• Verify a valid consent form is present in the chart.
• Confirm the patient:
  • Is knowledgeable about the procedure.
  • Is willing to undergo surgery.
  • Is competent to sign consent (e.g., legal adult, emancipated minor, married, military member, or a minor signing for their own child).
• Ensure the consent is properly signed and witnessed.

When a Certified Medical Interpreter is Mandatory

• An interpreter must be a Certified Medical Interpreter.
• Exclusions: Family members or coworkers cannot serve as interpreters.
• Documentation: The presence of the interpreter must be documented as “Interpreted by ___.”

When Two Signatures Are Required on Informed Consent

Two signatures are needed on a consent form in these situations:

• The patient is physically unable to sign (e.g., quadriplegic).
• Telephone consent is obtained (e.g., for parents of a child/minor).

Verifying Legal Custody/Guardianship of a Minor

• Nurse’s Responsibility: The nurse is not legally obligated to independently verify claims of legal custody or guardianship. The healthcare system operates on the assumption of good faith. If the claim is false, the legal responsibility falls on the individual making the claim.

Individuals Competent to Sign Their Own Informed Consent

• Legal Adult: (Age varies by state, usually 18).
• Emancipated Minor: (Age is irrelevant if emancipated, typically meaning they are financially independent, married, or in the military).
• Minor for Own Child: A minor can sign consent for their own child.

Use of Implied Consent

• Circumstances: Implied consent is permissible only when a patient is unconscious and there is an immediate threat to life, limb, function, or organ.
• Documentation Prerequisite: Physician Staff Notes MUST contain documentation of the emergency before implied consent can be invoked. This is a common point on exams.

Required Documentation Before Implied Consent

• Physician Staff Notes MUST include documentation of the emergency before implied consent can be used for emergency surgery.

Workplace Environment and Legal Principles

Maintaining a safe and ethical healthcare environment is crucial.

Joint Commission’s Zero Tolerance Policies

The Joint Commission has a strict zero-tolerance policy for workplace violence, recognizing its direct impact on patient safety through communication breakdown. This includes:

• Intimidation (sarcasm, incivility).
• Threats (screaming).
• Physical attacks (grabbing).
• Property damage (punching walls, slamming objects, breaking items).
• Sexual harassment.
• Bullying (verbal attacks, deliberate intent to harm, allowing someone to fail).
• Harassment (patronizing behavior).

Ethical Principles in Healthcare

• Beneficence: The duty to actively help others.
• Nonmaleficence: The fundamental principle to do no harm.
• Justice: Ensuring fairness and providing the same standard of care to all.
• Veracity: The commitment to truthfulness and providing a clear, accurate picture (e.g., accurate charting, using text boxes for clarity).
• Fidelity: Upholding faithfulness to commitments and loyalty. This assumes professional knowledge of job requirements, policies, standards, and practices.
  • Lack of Fidelity Examples: Patient abandonment (taking on too many patients beyond limits), poor staffing ratios (e.g., PACU nurse caring for more than two patients).

Types of Law

• Statutory Law:Written legal definitions of specific actions or rights.
  • Example: A state’s Nurse Practice Act, which defines the scope of nursing licensure.
• Common Law: Legal principles derived from judicial decisions and customs, not explicitly written statutes. Represents an understanding of how individuals are treated.
  • Example: The Patient Bill of Rights is a common law principle, not a statute. Patients cannot sue directly for a violation of the Bill of Rights.
• Civil Law: Laws based on rules and regulations, allowing individuals to sue for compensation due to a wrong.
• Tort Law: A category of Civil Law focused on wrongdoings or civil injuries (not necessarily physical injury) for which legal action can be taken for compensation.
  • Examples: Malpractice, negligence, surgery without consent, wrong-site surgery.

Types of Tort Laws

• Intentional Torts: Actions committed with a deliberate intent to cause harm or distress.
  • Assault: Placing a person in fear of being touched (intimidation, stress, causing fear). No physical contact is necessary.
  • Battery: Touching a person without permission, not necessarily causing harm. Performing surgery without consent is an example.
  • False Imprisonment: Unjustified detention (e.g., inappropriate use of restraints). Requires diligent documentation of reasons, frequent monitoring, and adherence to orders.
• Quasi-Intentional Torts: Actions that cause harm due to a mistake, but without direct intent to injure. Harder to prove.
  • Examples: HIPAA violations (looking through charts without cause), patient abandonment due to staffing issues.

Intentional vs. Quasi-Intentional Tort Distinction

• Intentional: Direct intent to cause harm or wrong (“You did me wrong”).
• Quasi-Intentional: A mistake was made, and harm resulted, but there was no direct intent to injure.

Criminal Law

• Definition: Legal actions concerning acts deemed harmful to society.
• Consequences: Can result in fines, imprisonment (e.g., practicing without a license).

Negligence

• Definition: Failure to act as a reasonably prudent person would under similar circumstances; “should have known better.”
• This includes not doing what one should have done based on training or doing what one should not have done.
• Ignorance is not an excuse for negligence (e.g., not knowing a new consent is needed for each surgical visit).

Malpractice vs. Negligence

• Malpractice: Implies intent. The individual knew they were acting wrongly but proceeded anyway. This is a form of professional negligence, signifying misconduct or a lack of skill in job execution.

Elements of Malpractice (The “Four Ds”)

To prove malpractice, all four elements must be demonstrated:

1. Duty of Care: The existence of a professional relationship where care was owed (e.g., clocking in, patient signing consent).
2. Dereliction of Duty: A failure to provide proper care.
3. Direct Causation: The direct link between the lack of care and the harm caused.
4. Damages: Actual harm or injury inflicted upon the patient (e.g., broken dentures).

Intentional Tort Actions: Assault, Battery, False Imprisonment

• Assault: Placing a person in fear of being touched; intimidation; causing stress; not having the patient’s best interest in mind. No physical contact required.
• Battery: Touching the patient without permission; not necessarily causing physical harm; performing surgery without consent.
• False Imprisonment: Unjustified detention; includes inappropriate use of restraints, requiring meticulous documentation of reasons, frequent renewals of orders, and provision of basic needs.

Patient Abandonment Classification

• Patient abandonment (e.g., working outside appropriate staffing ratios, walking off the job) falls under Quasi-Intentional Tort.

Actions Under Quasi-Intentional Torts

• Patient Abandonment.
• Defamation of Character: Criticizing a patient where they can overhear.
• Invasion of Privacy: Unauthorized viewing of patient charts.
• Breach of Confidentiality: Discussing patient information in public areas (HIPAA violations).

Nursing Documentation

Documentation is a critical aspect of nursing practice.

Purpose of Nursing Documentation

• To provide goal-directed care.
• To record nursing interventions (when, where, by whom).
• To document evaluations of care and patient response.
• To track outcomes.

Documenting Errors on Paper

• Method: Draw a single line through the error, ensuring the original entry remains legible.
• Policy: Further actions are determined by hospital policy.

Timestamps in Electronic Records

• Real-Time Documentation: Document as close to real-time as possible.
• Visibility: Timestamps are visible in every section of the electronic chart.
• Legal Implications: Pre-charting can have negative legal consequences. Never alter a record if it’s involved in a legal case.

Patient Handoffs

• Standardization: Can utilize a standardized handoff tool.
• Documentation: Must document the person, their title, and the location to whom care was transferred.
• Question Time: Allow adequate time for the receiving caregiver to ask questions.

Perioperative Nursing Data Sets (PNDS)

• Function: PNDS are embedded into charting systems, containing surgery-related diagnoses and nursing care plans.
• Benefit: Allows for efficient documentation and integrated nursing care planning.

Advance Directives

DNR vs. AND (Allow Natural Death)

• AND (Allow Natural Death): Always includes a plan for palliative care.
• DNR (Do Not Resuscitate): Can potentially withhold palliative care depending on the specific order.

DNR Orders in Surgery

• Effectiveness: A DNR order remains in effect during surgery UNLESS the physician writes an order in the chart to temporarily amend or suspend it.
• Specifics: The order must clearly document the particulars of the amendment or suspension.
• Patient/Provider Conversation: The patient, physician, and anesthesiologist must have a conversation to establish a plan for surgery (e.g., “Fix my hip fracture but don’t intubate me,” or “If I become hemodynamically unstable, let me go”).
• Clarification: Clarify whether interventions (e.g., for bleeding, bradycardia) can be performed to address immediate surgical complications.

RN Authority to Suspend a DNR

• RNs CANNOT accept verbal or telephone orders for DNR-related changes. Any amendment or suspension of a DNR must be a written order by the physician.

Surgical Tissue Banks and Specimens

Regulation of Surgical Tissue Banks

• Surgical tissue banks are regulated by:
  • AATB (American Association of Tissue Banks).
  • The Joint Commission.
  • FDA (Food and Drug Administration).

Why Autologous Tissue Must Be Separated from Allografts

• Infection Testing: Autologous tissue (from the patient’s own body) has not undergone testing for infectious diseases.
• Contamination Risk: It must be kept strictly separate from allografts (from donors) to prevent cross-contamination.

Required Information on Surgical Tissue

• Expiration date is mandatory.

Storage Requirements for Tissue Grafts

• Temperature Control: Must be kept in a refrigerator or freezer with limited access.
• Monitoring: Requires a temperature monitor with an alarm.
• Alarm Protocol: The alarm must be set to sound in a location that is continuously monitored.

Retention Period for Surgical Tissue Bank Records

• Surgical tissue bank records (consent, donor assessment, procurement, processing, preservation, labeling, storage, quarantining, testing, release, distribution, quality control) must be kept for 10 years.

Law Guiding Surgical Tissue Donors

• The Uniform Anatomical Gift Act of 1968 provides guidelines for tissue procurement from donors.

Donor Eligibility Guidelines (Uniform Anatomical Gift Act)

• Exclusions:
  • No active infection (sepsis).
  • No autoimmune disease (e.g., lupus).
  • No neurological disease.
  • No bone disease.
  • No systemic medication (e.g., chemotherapy).
  • Immobility: Cannot have been on a vent or immobile for more than 7 days prior to brain death (due to potential damage to heart and lungs).
  • Temperature: Must have been normothermic for the week before death.
• Inclusions (No “Lifestyle” Exclusions): Donors who were OD patients, IV drug users, or prostitutes are still eligible if testing confirms no infectious diseases.

Handling Dropped Human Donor Tissue

• Procedure:
  1. Thoroughly rinse the tissue with betadine and/or an antibiotic solution.
  2. Report the incident to infection prevention personnel.
  3. The surgeon should be placed on prophylactic antibiotics.
• Crucial Point: Do not discard the anatomical gift and retrieve another. However, if using donor tissue is no longer feasible, artificial materials may be used.

Unrecommended Practice for Donor Bone Tissue

• Do not steam sterilize bone, as it damages the bone structure.

Storing Autologous Tissue (e.g., Skull Flap)

• If autologous tissue is not going to be used immediately, it should be sent to the tissue bank immediately to prevent drying or contamination.

Required Information for Storing Autologous Tissue

• Patient Identification: Confirm with two unique identifiers.
• Origin: Specify the source of the tissue, including laterality (e.g., “right femur,” “T-L-level”).
• Tissue Type: Clearly state the type of tissue.
• Clinical Information: Include the diagnosis and any pertinent clinical details.

Specimen and Label Confirmation

• Specimens and their labels must be confirmed:
  • At the time of collection.
  • During debriefing with the surgeon.

Handling Legal Evidence Specimens

• Chain of Custody: Maintain a strict chain of custody to prevent tampering.
• Prevent Alteration: Prevent alteration of the specimen (e.g., remove a bullet with a plastic instrument or fingers; metal instruments can alter scoring).
• Prevent Decomposition: Place in a proper specimen container. (Crucial for exam).

Specimen Containers: Dry vs. Preservative

• Dry Container: For fresh, frozen, or cytology specimens.
• Preservative Container: For preserved or permanent (e.g., formalin) specimens.

Cytology vs. Microbiology

• Cytology: Examination of cell types in fluid (e.g., ascites).
• Microbiology: Culturing for microbial growth.

Container for Microbiology Specimens

• Microbiology specimens are placed in a culture medium (e.g., swabs).

Product and Medical Device Selection

Product and Medical Device Selection Process

• Standardization and Evaluation: A system for product and medical device standardization and evaluation should be in place.
  • Goal: To select functional and reliable products that are safe, cost-effective, and environmentally conscious.
  • Efficiency: Avoid duplication (e.g., consolidating instrument trays) and fads (trial new items based on need, not just novelty).
• Evaluation Criteria: Product evaluation must use criteria specific to the item’s use and need. It cannot be a generic tool.
  • Factors: Safety, ease of use, compatibility with other products, cost, and sterilization method.
• Clinical Evaluation: Conduct a clinical evaluation based on an identified need or opportunity.
  • Efficiency: Do not waste time trialing products that are not viable options.
  • Collaboration: All departments and stakeholders should participate, receive education, and undergo inservice training before a trial.
  • Parameters: Trials must have defined time and scope parameters.
• Personnel for ESU and Accessories: Personnel involved in selecting Electrosurgical Units (ESU) and their accessories are crucial.
  • Safety Focus: ESUs are a common source of patient problems. The primary goal is to minimize patient risk by prioritizing safety features.

The Nursing Process (ADPIE)

The Nursing Process is a systematic approach to patient care.

Steps of the Nursing Process

• A – Assessment:
  • Purpose: To gather comprehensive information necessary for patient care.
  • Actions: Collecting vital signs, assessing mobility and NPO status, evaluating communication abilities, checking allergies, conducting chart reviews, examining preference cards, and discussing procedural preferences with the physician. Asking questions specifically for patient care.
  • Outcome: To acquire data for formulating a nursing diagnosis.
• D – Diagnosis:
  • Purpose: To identify and classify the data collected during the assessment phase.
  • Autonomy: Nurses must be able to perform interventions to correct the identified issue without a physician’s order (e.g., actions to maintain skin integrity).
• I – Identification of Outcomes:
  • Purpose: To establish measurable goals that can be achieved through nursing care.
  • Format: Goals are always stated in the future tense (e.g., “Patient will remain free from infection”).
• P – Planning:
  • Purpose: To select the specific nursing interventions that will help achieve the desired outcomes or goals.
  • Actions: Outlining “how to” accomplish the goal (e.g., “how to remain free from infection”). Communicating the plan of care to the patient, family, and healthcare team (e.g., teaching crutch training).
  • Key Indicator: The act of gathering supplies and equipment with the explicit purpose of performing an intervention is considered part of the planning phase.
• I – Implementation:
  • Purpose: To execute the plan of care.
  • Actions: This is the “doing” phase; a verb-driven action performed directly with the patient.
  • Examples: Placing an IV, explaining a surgical procedure.
• E – Evaluation:
  • Purpose: To determine if the established goals were met.
  • Format: Always written in the past tense.
  • Outcome: If goals were not met (e.g., “The patient was not able to ambulate with crutches”), the process cycles back to reassessment and replanning.

NANDA (North American Nursing Diagnosis Association)

• Role: Provides the official list of approved nursing diagnoses.
• Focus: Nursing diagnoses describe a human response to a pathology.
• Types: Can be actual (e.g., “Alteration in skin integrity”) or potential (e.g., “Risk for alteration in skin integrity”).
• Autonomy: Nursing treatment for these diagnoses is designed to correct the issue without requiring a physician’s order.

Charting “By Exception” with PNDS

• When using PNDS embedded charting, nurses are charting “by exception.” This means standard interventions are assumed to be done unless otherwise noted.
• Modification: If standard options are inappropriate, the nurse uses an open text box to document specific actions for that patient. This is an example of modifying the Plan of Care.
• Individualization: Every patient effectively has an individualized Plan of Care because of this “charting by exception” approach with PNDS.

Nursing Process Step for Gathering Supplies/Equipment

• Planning is the nursing process step that involves gathering supplies and equipment with the purpose of performing an action.

Nursing Process Step for Direct Patient Action

• Implementation is the nursing process step that involves directly doing something with the patient, such as starting an IV.
  • (Gathering the supplies for the IV is Planning).