Informed Consent Components patients must be provided with all information needed to make an informed decision diagnosis or medical problem for which treatment is being recommended who will be performing surgery surgeons who have tested positive for HIV/HBV/HCV should disclose this to the patient at the time of scheduling of an "exposure prone" procedure description of the proposed treatment or procedure, including its purpose, duration, methods, and implements used, as well as the probability of success origin of surgical implants should be discussed with patients this may have implications for their use based on a patient's religious background in Hinduism, use of bovine-derived implants should be discussed in Judaism and Islam, use of porcine-derived implants should be discussed all material risks of the procedure or treatment any reasonable alternatives to the proposed procedure risks of not being treated Special situations Health Information Portability and Accountability Act (HIPAA) patient consent is not needed when communicating HIPAA-protected information to other treating providers clinical trials IRB approval for obtaining informed consent from patients enrolled in clinical trials is required IRB approval is not required for quality improvement studies used for internal purposes only purpose of the IRB is to ensure the rights and welfare of human subjects participating in research elective procedures informed consent for elective surgical procedures is best obtained in the office/clinic setting a few days prior to scheduled procedure emergent procedures in absence of legal consent confirm necessity of procedure in life-threatening injuries requiring surgical intervention but without available legal consent, the surgeon should confirm and document the necessity of care with a fellow orthopaedic surgeon or colleague in non-life threatening injuries, consent must be obtained prior to surgical intervention (e.g. language barrier, pediatric patient) non-consentable patients legal guardians have highest precedence "next of kin" precedence has been established to assist in determining order of consent: spouse, children (in no order), parents, siblings, grandchildren Patient-physician relationship termination of care can be initiated by the physician with due process the patient must be notified in writing the relationship with be terminated a grace period of 30-45 days of continued care to allow the patient to arrange for further treatment termination without a grace period is considered abandonment Physician Errors Communication errors leading cause of wrong-side surgeries, medication errors, diagnostic delays, or loss to follow-up results in increased treatment costs, treatment delays, and complications Crew Resource Management has been shown to improve communication and team dynamics has led to an improvement in patient safety and team morale Wrong site surgery prevention involve the patient in identifying correct side in the pre-operative area and prior to induction display pertinent imaging in the operating room mark the correct site with the surgeon's initials visibly in the surgical field perform a time-out with the operating room team prior to incision response when performed acknowledge error with immediate discussions with the family apologize and accept responsibility, but do not place blame Surgical errors prevention surgical "time-out" according to JCAHO, should include the following identify correct patient, site, and side verify the correct procedure all members of the team should be present for the time out; alternatively, it can be repeated surgical safety checklists WHO implementation began in 2009 results in measureable improvements in surgical mortality in-hospital complications adherence to surgical plan in OR crisis situations (e.g., massive hemorrhage, cardiac arrest) surgeon is most effective OR team member at reducing complications when using surgical checklist and "time-out" Medication prescribing errors reduced when physicians use computerized order entry Medical documentation errors altering the medical record for any reason is illegal no one has the authority to authorize a physician to alter the medical record errors can be noted and addendums can be added Second opinions the second opinion surgeon is ethically required to disclose the effect of medical errors on patient outcome only the patient can unilaterally decide to transfer care to a second surgeon the surgeon is not ethically allowed to seek out transfer of care of a patient Litigation Overview medical liability lawsuits involving orthopaedic surgeons increased by 13% from 2003 to 2008 thought to be related to the aging population compared to other specialties, orthopaedic surgery has the 7th highest # of lawsuits ~33% of all orthopaedic surgery claims result in payment to plaintiffs average cost of defending orthopaedic surgery claims is ~$47,000 USD Causes of lawsuits (as of 2008) "improper performance" makes up 45% of lawsuits most commonly associated procedures operative procedures of joint structures (not including spinal fusion) open reduction of dislocation closed reduction of fractures operative procedures on bones operative procedures on cranial and peripheral nerves most commonly associated clinical diagnoses osteoarthritis (21%) disorder of joint, not including arthritis fracture of femur Legislation Stark Law (1993) A federal regulation that prohibits self-referral of physicians to organizations with which they have a financial relationship. Patient Protection and Affordable Care Act (2010) provides numerous rights and protections that make health coverage more fair, easier to understand, and more affordable Physician Payments Sunshine Act (2010) requires collection and reporting of financial relationships between physicians/teaching hospitals and businesses (manufacturers of drugs, devices, medical supplies) all payments > $10 must be reported to Centers for Medicare and Medicaid Services Physician Impairment Defined as the inability or impending inability to practice according to accepted standards due to substance use, abuse, or dependency/addiction Surgeons (resident, fellow or attending) who discover chemical impairment, dependence, or incompetence of a colleague or supervisor has a responsibility to ensure that the problem is identified and treated Medical Negligence Negligence is the failure to provide the standard of health care resulting in medical injuries A second-opinion physician has an ethical obligation, but not a legal obligation, to disclose if the standard of care has been breached by a treating physician Successful patient-plaintiff lawsuits for medical negligence require that all of the following 4 elements be alleged and proven in a court of law duty obligation to provide care that meets the professional standard of care, i.e. the same standard of care ordinarily executed by surgeons in the same medical specialty breach of duty occurs when action or failure to act deviates from the standard of care causation established if it is demonstrated that failure to meet the standard of care was the direct cause of the patient’s injuries damages monies awarded as compensation for injuries sustained as the result of medical negligence Workers Compensation Principles maximum medical improvement is reached when further restoration of function is no longer anticipated, allowing patients to settle their claim ability of patients to choose their own physician varies according to statutes of each state Legal definitions impairment loss of function resulting from an anatomic or physiologic derangement disability limitation of an individual’s capacity to meet certain personal social or occupational demands Physician Employment Independent contractor relationship employer influences the outcome contractor determines the methods and means of achieving result of work pay and benefits employer does not pay taxes, provide insurance, or offer retirement benefits Employed relationship employer determines the result of the work and provides the means and methods for the result provision of resources and training pay and benefits the employer pays taxes, provides insurance, and retirement benefits