Medical-Legal Aspects of Nurse Anesthetist Practice

1. Medical-Legal Aspects of Nurse Anesthetist Practice Jeffrey Groom, PhD, CRNA, ARNPFIU Anesthesiology Nursing Program

2. Medical-Legal Aspects of Nurse Anesthetist Practice • Reference Resources • Ch 4 Legal Issues in Nurse Anesthesia by Nagelhout and Plaus • A Professional Study and Resource Guide for the CRNAChapters 5,6,7 • AANA General Counsel Gene Blumenreich, JD • AANA Legal Briefs – Newsletter/Journal/AANA Web • www.aana.com > RESOURCES > Legal Briefs • Lecture does not constitute legal advice and doesnot substitute for the services of an licensed attorney

3. Relationship of Medicine & Law • Forensic Medicine • Regulation of service& health professionals • Regulation between partiesPatients & Providers

4. Sources of Law Federal – State – Local • Constitution • US Constitution • State Constitution • Statutes • Federal and State • Administrative Regulations • Common Law • Case law – Doctrine of Stare Decisis • Fair, Consistent, Predictable, Effectuates public policy

5. Interrelationship of Laws CONSTITUTION Government Legislative Executive Judicial Enacts Statutes Creates Empowers Enforce Interpret Creates Attorney Gen Constitution Laws Common Law Amend or Abolish Administrative Agencies AdministrativeAgencies Professional Boards Create-Execute-Judge Administrative Regulations

6. CRNA’s and the LAW • Federal vs State vs Local • Criminal vs. Civil • Adult/Juvi/Family vs Contracts/Torts • Substantive vs Procedural • Laws vs. Administrative Rules

7. CRNA’s and the LAW Perception is biggest area of concern is malpractice (civil) ADMINISTRATIVE CRIMINAL CIVIL In reality, the numbers show just the opposite….

8. CRNA’s and the LAW • Florida Nurse Practice Act • ARNP • Federal/State Regulatory Statutes • DEA, FDA, HICFA, HIPPA • AANA – Professional practice guidelines • National Board on Certification and Recertification of NAs (NBCRNA) • CRNA • Practice Facility • JCAHO, Credentialing & Staff Privileges • Practice Group • Protocols and Policies • Liability Insurance Provider • Policy Terms – Limits - Provisions • Medicare and Medicaid Regulations • National Provider Identifier ( http://npienumerator.com/ )

9. CRNAs and the LAW • Florida Nurse Practice Acthttp://www.leg.state.fl.us/Statutes/index.cfm?Mode=View%20Statutes&Submenu=1&Tab=statutes • Laws vs. Administrative Ruleshttp://www.leg.state.fl.us/Statutes/index.cfm?Mode=View%20Statutes&Submenu=1&Tab=statutes • Department of Health – Medical Quality Assurance Servicehttp://www.doh.state.fl.us/mqa/index.html • Florida Nurse Practice Acthttp://www.leg.state.fl.us/Statutes/index.cfm?Mode=View%20Statutes&Submenu=1&Tab=statutes • Laws vs. Administrative Ruleshttp://www.leg.state.fl.us/Statutes/index.cfm?Mode=View%20Statutes&Submenu=1&Tab=statutes • Department of Health – Medical Quality Assurance Servicehttp://www.doh.state.fl.us/mqa/index.html • Florida Nurse Practice Acthttp://www.leg.state.fl.us/Statutes/index.cfm?Mode=View%20Statutes&Submenu=1&Tab=statutes • Laws vs. Administrative Ruleshttp://www.leg.state.fl.us/Statutes/index.cfm?Mode=View%20Statutes&Submenu=1&Tab=statutes • Department of Health – Medical Quality Assurance Servicehttp://www.doh.state.fl.us/mqa/index.html

10. Provider – Patient Relationship • Individual vs Group Practice • Fiduciary Relationship • Privileged Communications

11. Provider – Patient Relationship • Contractual Relationship(Service contract vs Sale contract) • Offer • Consideration • Acceptance

12. Provider – Patient Relationship Duty of Providers to Patients • Practice at professional level • Make full disclosure • Protect confidence • Offer continuing treatment • Seek consultation when indicated

13. Provider – Patient Relationship Duty of Patients to Providers • Make full disclosure • Full cooperation in treatment • Pay for services rendered as per the agreement

14. Provider – Patient Relationship Breach of Contract vs Negligence • DUTIES • Professional Care • Disclosure • Confidence • Treatment • Consultation Breach of Duty Breech of Contract vsProfessional Negligence Intentional Tort Criminal and Negligence Action

15. Intentional Torts • Abandonment • Assault • Battery • Breech of Confidence • Defamation • False Imprisonment • Fraud • Intentional infliction of emotional harm • Invasion of privacy

16. Professional Negligence • Malpractice is negligence within a professional activity • Tort is a civil wrong committed by: • action or omission • intentional or negligent Perception- most malpractice is for something done wrong Most actions for negligence are for: - omission (what should have been done and was not) - negligence (no reason not to have done what was omitted)

17. Dowe, Shaftem & Nailem 305-555-1212 Professional Negligence • Anyone can allege or sue for negligence. (Didn’t listen – Didn’t care) • Whether or not negligence occurred is decided in court. • Proof of negligence: • Duty • Breech • Injury • Causation • Damage

18. Professional Negligence Analysis of negligence: • Duty – contractual relationship • Breech – standard of care • Injury – substantiated injury • Causation – proximate causation • Damage – special, general, punitive

19. Professional Negligence Standard of Care • Reasonable person vs. professional • Local practice vs nationwide • Anesthesia care – single standard of care • Standards of Practice • Professional Organizations • Practice Standards and Guidelines • Changing standards • Advances in practice (Washington vs. Washington Hospital – 1987) • Common law • Standard of Care in the Courtroom

20. Professional Negligence Res ipsa loquitur • Defendant in exclusive control • Patient not contributory negligent • Patient did not observe negligence • Could not have occurred otherwise • Common knowledge that the act would cause injury

21. Professional Negligence Defenses to Negligence Action • Immunity • Conduct met standard of care • Contributory negligence by pt. • Comparative negligence by other providers on the case • Assumption of risk • Consent

22. Liability of Anesthesiology • Dose of anesthetics required to produce general anesthesia is very close to, or exceeds the LD50. • General anesthetics deprive patients of their protective respiratory reflexes risking obstruction and aspiration. • Airway management problems are not uncommon thus risking hypoxia or anoxia. • Some general anesthetics and all muscle relaxants depress or obliterate spontaneous respiration.

23. Liability of Anesthesiology • Some components of balanced general anesthesia adversely affect sympathetic activity, vasomotor tone, myocardial function, especially in patients on antihypertensives. Stage is set for potential hypotension, myocardial depression, and circulatory collapse. • Some forms of regional anesthesia, spinal and epidural, may cause cardiovascular collapse from total spinal or cardiotoxicity.

24. Liability of Anesthesiology • Attempts to produce spinal anesthesia may result in a high or total spinal, or produce spinal nerve or spinal cord injury. • Techniques of invasive monitoring may produce adverse complications or death. • Short term patient contact, and differing personnel from preop to intraop and postop. • Team care delivery is also team liability

25. Medical-Legal Aspects of Nurse Anesthetist Practice Jeffrey Groom, PhD, CRNA, ARNPFIU Anesthesiology Nursing Program

26. Medical-Legal Aspects of Anesthesiology • Laws and the CRNA • Provider-Patient Relationship • Duties of Providers & Patients • Elements of Negligence Action • Standard of Care

27. Minimizing Exposure to Liability • Risk Management • Preanesthesia Evaluation • Informed Consent • Anesthesia Record • Patient Care • Anesthesia Monitoring • Postanesthesia care

28. Risk Management • Handling Risks - Methodology • Assumption of risk – self insured • Transferal of risk – zero deductible • Sharing of risk – predetermined deductible • Avoidance of risk – not practicing in field • Attenuation of risks – Risk Management • Risk management – • Injury Prevention • Liability Control

29. Risk Management • Injury Prevention • Database (complaints, incident reports, reports) • Audits and review • Remedial measures • CQI measures • Evidence based safety practices • Liability Control • Review of incident (record, staff, review) • Identify “Potentially Compensatable Event” (PCE) prior to litigation • May opt to offer up (conditional) settlement option(s) to patient/family prior to formal litigation

30. Risk Management Managing a PCE • Is this a PCE ? • Should we be responsible? • Inform patient or next-of-kin – “We are sorry. What happened probably should not have happened. We will do our best to correct the situation by doing...1,2,3..” • Correct the problem • Compensation options • Open Communication

31. Medical Incidents Regulations regarding health care facilities • Requires health care facilities and practitioners to inform patients or the patients’ representatives of adverse medical incidents that result in harm to the patient. • Requires patient safety plans, patient safety officers and safety committees in all surgical facilities. • Requires all facilities to report the name and judgments against health care practitioners. • Requirement all surgical facilities to notify the Agency for Health Care Administration (AHCA) within 1 business day of the occurrence of adverse incidents. • Establishes a privilege from discovery or introduction into evidence in any civil or administrative action for patient safety data. • Makes activities done pursuant to quality improvement review, evaluation, and planning in a state-licensed health care facility immune from civil liability. • Revises the closed claim reporting requirements, requires medical error CME, provision for license suspension for nonpayment, new limits $ 250/750

32. Liability for no Risk Management • FS 766.110 Liability of health care facilities.-- (1) All health care facilities, including hospitals and ambulatory surgical centers, as defined in chapter 395, have a duty to assure comprehensive risk management and the competence of their medical staff and personnel through careful selection and review, and are liable for a failure to exercise due care in fulfilling these duties.

33. Risk Management Legal Risks of Risk Management • Remediation/Corrective actions are not evidentiary • RM, IR UR Records not discoverable (FS 766.101 Medical review committee, immunity from liability) • Attorney-Client Privilege • Risk of having NO Risk Management

34. Risk Management Incident Reports • Complete as a medical record, do ASAP • Attach printouts/pics if norm part of case • Confine and tag suspect equipment • Treated as confidential document • DO NOT place in medical record • Limit report to facts, not conclusions, accusations or blame • Address IR to Risk Manager or Attorney • Limit copies and distribution to RM & Attny • Should you keep a personal file copy ( ? )

35. Preanesthesia Evaluation • Standards & Goals of Assessment • Patient Evaluation • Anesthesia Plan • Patient Education • Patient Counseling Personnel Communication Informed Consent • Patient Instructions • Documentation & Relay of Information

36. Preanesthesia Evaluation Potential Legal Issues • DUTIES • Professional Care Thorough evaluation/labs • Risk Disclosure Disclosure you’d want • Confidence Need to know basis • Treatment Inform pt who will do what • Consultation Consult as needed Performance

37. When PCE becomes a Law Suit Hear ye, hear ye….court is now in session…sit down and shut up!

38. Legal action alleging Negligence or Medical Malpractice • Litigation Process • Appeal Process • Doctrine of Stare Decisis • Sutherlin v. Fenenga - 810 P. 2d 353

39. Informed Consent • Consent is founded in the 4 and 14th Amendments to the Constitution and subsequently upheld in Common Law • Right to privacy and self-determination • Consent is an exemption from Battery • Informed consent is founded on the fiduciary relationship with patient

40. Informed Consent • Capacity to consent, or withhold consent • Legal age and capacity • Minors and incompetent adults • Minor with child is able to consent for self/child • Spouse and relatives (do not necessarily have statutory authority to grant consent/refusal) • Consent vs. Informed Consent • Contract law – meeting of the minds • Implied Consent • Express Consent • Written consent – tangible and contemporaneous

41. Informed Consent • Defective Consent • Arguments to written consent • Not specific • Not understood • Consent without disclosure of risks • Treatment withheld before consent • Disclosure required • Florida mandates IC by Professional standard as per statute and case law (FS 766.103 and Meretsky v. Ellenby 370 So.2d. 1222) • Must disclose “substantial risk” not all risks

42. Informed Consent • Reasonable-Patient standard • Patient must show they would have declined procedure had they known of risk • Exceptions to “informed” consent- • Patients elects not to be informed • Emergency situation (life or limb) • Therapeutic exception

43. Informed Consent • Informed consent in anesthesia practice • Emergency vs. elective • Inherent risks vs. risks but for negligence • Risks of anesthesia care, invasive monitoring, and blood products • Documentation of informed consent

44. DNR and Advance Directives • DNR is often considered suspended during the time of surgery – but should be discussed with patient/family and OR team. • Advance Directives may or may not be considered suspended during the time of surgery – but should be discussed with patient/family and OR team.

45. Anesthesia Record • First anesthetic 1846, first anesthesia record 1894/1902 • JACHO Standard for Medical Records MR1.2 • Anesthesia Record (JCAHO SA1.5) • Preanesthesia Assessment • Intraoperative record • Postoperative Care Unit record • Postanesthesia care note • “If it’s not in the record, it wasn’t done” has exceptions…but few…

46. Anesthesia Record

47. Anesthesia Record • Evidentiary value of the Anesthesia Record • Subpoena duces tecum • Subpoena ad testificandum • Privilege and Confidentiality • Spoliation • Corrections or additions • Automated records

48. Anesthesia Record • 456.057 Ownership and control of patient records; report or copies of records to be furnished.— (4) Any health care practitioner licensed by the department or a board within the department who makes a physical or mental examination of, or administers treatment or dispenses legend drugs to, any person shall, upon request of such person or the person's legal representative, furnish, in a timely manner, without delays for legal review, copies of all reports and records relating to such examination or treatment, including X rays and insurance information.

49. Anesthesia Record • 766.204 Availability of medical records for presuit investigation of medical negligence claims and defenses; penalty.-- (1) Copies of any medical record relevant to any litigation of a medical negligence claim or defense shall be provided to a claimant or a defendant, or to the attorney thereof, at a reasonable charge within 10 business days of a request for copies, except that an independent special hospital district with taxing authority which owns two or more hospitals shall have 20 days. It shall not be grounds to refuse copies of such medical records that they are not yet completed or that a medical bill is still owing.

50. Limiting Liability Identification, Transfer & Position • Identification • By name and confirmation • By ID band and confirmation • Confirm ID of charts, records, meds • High risk – kids, geri-, language, hand-offs • Time-Out procedures should be strictly followed and documented as per policy