Legal Concepts, Risk Management, & Ethical Issues

1. Legal Concepts, Risk Management, & Ethical Issues ST210 Concorde Career College

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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 Terms

9. Torts • 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

10. 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

11. 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.

12. 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

13. Patient Misidentification Incorrect procedure Foreign Bodies left in patients Burns Positioning 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 Abandonment O.R. Incidents

14. 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.

15. 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.

16. 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:

17. 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.

18. 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

19. 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

20. 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)

21. 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.

22. 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).

23. “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

24. 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”.

25. Consent • 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)

26. Who Can Give Consent? • Competent adult • Parent of legal guardian of a minor • Hospital administrator • Courts

27. 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

28. 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

29. 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

30. 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

31. 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

32. 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

33. 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

34. 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

35. Written Informed Consent cont. • Witnesses are defined by hospital policy and may include: • Physician • RN • CST • Other hospital employee

36. 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

37. Consent • 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

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

39. 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

40. 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

41. 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

42. Advanced Directives • Written instruction dealing with the right of an incapacitated patient to self-determination • Examples: • Living will • Medical power of attorney

43. 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.

44. 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.

45. Bioethics • The study of the ethical implication of biological research and applications, especially in medicine. • The focus is to maximize total human benefits.

46. 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

47. 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

48. 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

49. 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

50. 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