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Updated: Jun 18 2021

Informed Consent & Time Out

  • Elective Procedures Informed Consent
    • Informed consent for an elective surgical procedure is best obtained by the physician in the office/clinic setting a few days before the scheduled procedure
    • Surgeon must provide to the patient all information that is needed for the patient to make an informed decision
      • who will be performing surgery should be disclosed
      • the surgeon should disclose to the patient at the time of scheduling an "exposure prone" procedure if the surgeon has tested positive for HIV, Hepatitis B or C
    • Important to understand the important risks and benefits as well as the indications for and alternatives to a procedure
    • 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
  • Emergency Procedure Informed Consent
    • confirm necessity of procedure
      • in situation of required surgery for life threatening injury 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 injury, consent must be obtained prior to intervention (e.g. language barrier, pediatric patient)
      • The "Next of Kin" precedence that has been established is in the following order: spouse, children (in no order), parents, siblings, grandchildren
  • Informed Consent for Clinical Trial
    • Health Information Portability and Accountability Act (HIPAA)
      • Provider does not need consent from patient to communicate HIPAA protected information to other treating providers
    • Process for obtaining informed consent for patients included in clinical trials is mandated by the Institutional Review Board (IRB)
      • IRB approval is not required for quality improvement studies used for internal purposes only
  • Surgical Safety Checklists
    • WHO implementation of surgical safety checklists began in 2009
    • Implementation has demonstrated measureable improvements in:
      • surgical mortality
      • in-hospital complications
      • adherence to surgical plan in OR crisis situations (e.g., massive hemorrhage, cardiac arrest)
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