Updated: 1/1/2021

Informed Consent & Time Out

Review Topic
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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