Informed Consent Update: Manoeuvring the Maze CMS, Joint Commission, DNV and other Standards on Informed Consent Every Hospital Should Know

Product Id : HE161
Instructor : Sue Dill Calloway
Jul 29, 2019 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 90 Minutes

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Ever been confused about what standards and guidelines apply to informed consent? This program will discuss the current CMS hospital Conditions of Participation (CoPs), including the critical access hospital, Joint Commission and DNV Healthcare standards on informed consent requirements. It will include some confusing CMS changes such as having a patient advocate sign the consent form when present even if the patient is competent.

It will cover the Joint Commission revised informed consent standards. This includes the requirements for discussion of recuperation.

This program will discuss standards on consent for research. Not doing this right can also cost hospitals money. A study found that consent forms were missing in 66% of patients delaying 10% of surgical procedures. The researchers at Johns Hopkins found the cost of lost misplaced consent forms cost hospitals $580,000 a year.

Healthcare providers must also be aware of their specific state law on informed consent. Many professional organizations, like the American College of Surgeons, American Society of Anaesthesiologists, and the American Association of Nurse Anaesthetists also have guidelines or position statements on informed consent. Come join us for a fun session on making informed consent a little simpler to understand!

Learning Objectives:

  • Recall that the CMS hospital CoP interpretive guidelines have 3 separate sections on informed consent.
  • Explanation of the hospitals and critical access hospitals have a separate guideline from CMS on informed consent and they are very different.
  • Description of the six minimum requirements that are now mandatory to be in the informed consent form for surgery done at a hospital that receives Medicare reimbursement including that the name of the hospital must always be on the form.
  • Discuss that there the CMS and accreditation standards applicable to your facility should be reflected in the hospital’s policies and procedures
  • Identify that the medical staff must have a list of procedures and tests that will require an informed consent under federal regulations.


  • Introduction to the Hospital CoP Informed Consent Requirements
    • CMS interpretive guideline on informed consent for hospitals
    • Three sections in hospital CoP
    • Update policies and procedures
    • Educate staff including medical staff
    • Consent from the patient who is not incapacitated and the patient representative
    • Consent when the patient is incapacitated
    • Patient advocate asked to sign consent even if patient is competent
  •   Informed Decision Section 1 CMS Hospital CoPs  
    • Informed consent as a process
    • Right to make informed decisions
    • Right to be informed of health care status
    • Right to refuse care
    • Evaluate patient rights 
    • Right to delegate right to another for informed decisions
    • Surrogate decision makers
    • Right to participate in plan of care after discharge
    • Right to receive understandable information
    • Policies and procedures required
    • Survey procedure for surveyor
  •  Surgical services Section 2 CMS Hospital CoPs   
    • Consent form on chart before surgery
    • Emergency exception
    • Short- and long-term risks
    • Benefits
    • Physician professional judgment
    • Surgery definition
    • Hospital must assure consent process
    • Anaesthesia consent required
    • Surgery consent policy requirements
    • Documentation in medical record
    • Elements of well-designed consent process
    • Important tasks related to surgery and disclosure
    • Medical record review by surveyor
  • Medical Records-Section 3 CMS Hospital CoPs
    • Inpatients and outpatient requirement
    • Consent on chart prior to surgery
    • Minimum elements in informed consent
    • Name of hospital on consent form
    • Signature of patient on consent form required
    • Surveyor review of six charts
    • Surveyor procedure
  • CMS Critical Access Hospital CoPs
    • 2 separate sections in CAH manual
    • Consent requirements
    • Significant surgical tasks
    • Consent as a process
    • Mandatory and optional requirements
  • Joint Commission Informed Consent Standards
    • Remember state law requirements
    • RI.01.03.01 and the revised EPs and recuperation
    • Written policy requirements
    • Surgery and procedures requiring consent must be specified
    • Consent as a process
    • Elements not required by CMS
    • Emergency surgery
    • Consent on chart required before surgery
    • Consent for photography
    • TJC tracer on consent

Who Will Benefit:

  • CEO
  • Compliance Officer
  • Chief Medical Officer
  • CNO
  • Nurse Educator
  • Nurse Directors/ Supervisors,/Managers
  • Board Members
  • Physicians
  • Medical staff coordinator/patient safety officer/senior leadership/hospital legal counsel
  • Risk Manager
  • Ethics Committee and others responsible for compliance with hospital regulations, and persons responsible for rewriting policy and procedure on informed consent.
Speaker Profile:

Sue Dill Calloway, RN, MSN, JD, is the president of Patient Safety and Healthcare Consulting and Education company with a focus on medical-legal education especially Joint Commission and the CMS hospital CoPs regulatory compliance. She also lectures on legal, risk management and patient safety issues. She was a director for risk management and patient safety for five years for the Doctors Company. She was the past VP of legal services at a community hospital in addition to being the privacy officer and the compliance officer. She was a medical malpractice defense attorney for ten years. She has 3 nursing degrees in addition to a law degree.

She is a well-known lecturer and the first one in the country to be a certified professional in CMS. She also teaches the course for the CMS certification program. She has written 102 books and thousands of articles.

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