CMS, Joint Commission, DNV and other Standards on Informed Consent Every Hospital Should Know

Event Information
Product Format
Prerecorded Event
Sue Dill Calloway, RN, MSN, JD
Conference Date
Thu, Nov 17, 2016
90 minutes
Product Description

Get to know the CMS guidelines on informed consent for hospitals and critical access hospitals

Ever been confused about what standards and guidelines apply to informed consent? This program will discuss the current CMS hospital Conditions of Participation (CoPs), 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.

The Joint Commission informed consent standards will also be covered. Expert speaker Sue Dill Calloway, will analyze standards on consent for research. Not doing this right can also cost hospitals a lot of money. A recent 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 loss of misplaced consent forms cost hospitals $580,000 a year. Besides being a financial issue CMS, TJC, DNV Healthcare and other accreditation organizations are scrutinizing the standards. A memo by CMS showed this is a common deficiency among hospitals.

The hospital must follow the consent regulations for all patients and not just Medicare and Medicaid hospitals. Failure to follow these regulations could result in the hospital being excluded from the Medicare program. Hospitals should ensure that their policies and procedures reflect the CMS requirements and that their staff are educated their staff on these informed consent interpretive guidelines. There are six mandatory elements and additional ones which are optional for hospitals to adopt. CMS requires the hospital to ensure that physicians are following these guidelines. Consent is a process and not just having a signed form.

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 Anesthesiologists, and the American Association of Nurse Anesthetists 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!

Session Highlights:

  • CMS hospital CoP interpretive guidelines has 3 separate sections on informed consent,
  • Explain the hospitals and critical access hospitals have a separate guideline from CMS on informed consent and they are very different,
  • Analyze the 6 minimum requirements which are now mandatory to be in the informed consent form for surgery done at a hospital which receives Medicare reimbursement including that the hospital’s name must be there on the form,
  • Know that the CMS and accreditation standards applicable to your facility must 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

Session Outline:

  • 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
    • Anesthesia consent required
    • Surgery consent policy requirements
    • Documentation in medical record
    • Elements of well-designed consent process
    • Risks, benefits, alternatives etc,
    • Surgical residents, RNFA, surgical Pas,
    • Important tasks related to surgery and disclosure,
    • Surgical resident section,
    • Moonlighting resident or fellow,
    • MS must approve list of when consent is required,
    • Surveyor to interview patients on process,
    • 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,
    • Revised witness requirement,
    • Material risk definition,
    • Signature of patient on consent form required,
    • Additional elements to consider on consent form,
    • 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 EPs
    • Written policy requirements
    • Surgery and procedures requiring consent must be specified
    • Consent as a process
    • Risks benefits, and side effects
    • Elements not required by CMS
    • Exceptions to policy
    • Emergency surgery
    • Consent on chart required before surgery
    • Consent for photography
    • TJC tracer on consent
  • DNV Healthcare Standard on Informed Consent
  • Research Informed Consent Requirements
  • Professional Organization Resources on Consent
  • Additional Resources Slides Provided on:
    • AAAHC and AAAASF Standards on Consent
    • AOA HCFA Standard on Informed Consent

Who Should Attend?

CEO, Compliance officer, chief medical officer (CMO)  chief nursing officer (CNO), COO, Nurse Educator, Nurses, Nurse Directors, Nurse Supervisors, Nurse Managers, Board Members, Physicians, Medical staff coordinator, patient safety officer, senior leadership, hospital legal counsel, Risk Manager, Chief Risk Officer, PI director, Joint Commission or DNV coordinator, director of health information management, director of anesthesia, OR nurse director, nurses, Patient Safety Officer, Pastoral Care, Patient Advocates, Ethics Committee and others responsible for compliance with hospital regulations, and persons responsible for rewriting policy and procedure on informed consent

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

Order Below or Call 1-866-458-2965 Today

You can also order through:




About Our Speaker

Sue Dill Calloway - Hospital Coding Expert

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...   More Info
More Events By The Speaker

Why AudioEducator?
  • Save money on travel.
  • Meet your specific training needs.
  • Keep learning after the event.
  • Save time training your whole staff.
Join Our Mailing List
Our Accreditation Partners
Facebook Twitter Linkedin Youtube RSS Feeds Google Plus
Audio Educator


Dear Valued Customers


We regret to announce that ProEdTech LLC and all its affiliate brands will cease operations on April 1, 2019.


We are no longer able to fulfill online orders. We will fullfill all DVD and book orders already placed.


Customers of canceled webinars and subscription products may request a refund at (800) 223-8720 or You must do so by April 1, 2019.


Thank you for your business and loyalty over the years. We sincerely apologize for any inconvenience caused.


Best regards,

The ProEdTech Team