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Description
Informed consent is a fundamental requirement in healthcare, ensuring that patients understand and agree to medical treatments before they are performed. However, compliance with informed consent regulations can be complex due to varying standards from CMS, The Joint Commission, and DNV Healthcare.
Failure to meet these requirements can result in citations, legal risks, and financial penalties. Healthcare organizations must understand these standards to ensure compliance and protect patient rights.
What is Informed Consent?
Informed consent is a process, not just a signed document.
It ensures that patients:
- Understand their condition
- Know treatment options
- Are aware of risks and benefits
- Have the right to refuse care
CMS Informed Consent Requirements
Under CMS Conditions of Participation (CoPs):
- Consent must be obtained before procedures
- Documentation must be in the medical record
- Policies and procedures must be clearly defined
- Staff must be trained on consent processes
CMS includes multiple sections covering consent requirements
Key Elements of a Valid Consent Form
Hospitals must ensure consent forms include:
- Patient identification
- Procedure details
- Risks and benefits
- Alternatives
- Signatures
CMS requires specific mandatory elements for compliance.
Joint Commission Standards on Informed Consent
The Joint Commission focuses on:
- Patient rights
- Clear communication
- Policy documentation
- Consent as an ongoing process
DNV Healthcare Standards
DNV Healthcare emphasizes:
- Documentation accuracy
- Policy alignment with CMS
- Survey readiness
Common Informed Consent Deficiencies
Hospitals often face issues such as:
- Missing consent forms
- Incomplete documentation
- Lack of staff training
- Failure to follow policies
These are frequently cited during CMS surveys.
Why Informed Consent Matters
Failure to comply can lead to:
- Legal liability
- Delayed procedures
- Financial losses
- Patient safety risks
Studies show missing consent forms can delay surgeries and increase costs significantly.
Best Practices for Compliance
- Develop clear policies
- Train staff regularly
- Conduct internal audits
- Ensure proper documentation
- Treat consent as a continuous process
Learn how to simplify informed consent compliance and avoid costly deficiencies.
Learning Objectives
- Recall that the CMS hospital CoP interpretive guidelines have 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,
- Describe 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 informed consent under federal regulations.
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
- The patient advocate asked to sign consent even if the 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 the 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 the chart before surgery
- Emergency exception
- Short and long term risks
- Benefits
- Physician professional judgment
- Surgery definition
- The hospital must assure consent process
- Anesthesia consent required
- Surgery consent policy requirements
- Documentation in the medical record
- Elements of the 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 (MEC) must approve the list of when consent is required
- Surveyor to interview patients on the process
- Medical record review by the surveyor
Medical Records-Section 3 CMS Hospital CoPs
- Inpatients and outpatient requirement
- Consent on chart before surgery
- Minimum elements in the informed consent
- Name of the hospital on the consent form
- Revised witness requirement
- Material risk definition
- Signature of the patient on consent form required
- Additional elements to consider on the consent form
- Surveyor review of six charts
- Surveyor procedure
CMS Critical Access Hospital CoPs
- 2 separate sections in the CAH manual under tags 304 and 320
- 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
- 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
Professional Organization Resources on Consent
Who Should Attend
- CEO
- Compliance officer
- Chief medical officer (CMO)
- Chief nursing officer (CNO)
- COO
- Nurse Educator
- Nurses
- Nurse Directors/ Supervisors
- Nurse Managers
- Board Members
- Physicians
- Medical staff coordinator
- Patient safety officer
- Senior leadership
- Hospital legal counsel
- Risk Manager
- Chief Risk Officer
- QAPI director
- Joint Commission or DNV coordinator
- Director of health information management
- Director of anesthesia
- OR nurse director & nurses
- Patient Advocates
- Ethics Committee and others responsible for compliance with hospital regulations
- Any individual, responsible for rewriting policy and procedure on informed consent
Faqs
What is informed consent in healthcare?
A process where patients agree to treatment after understanding risks and options.
What does CMS require for informed consent?
Proper documentation, policies, and patient understanding before procedures.
Is informed consent just a form?
No, it is an ongoing communication process.
What are common consent mistakes?
Missing forms, incomplete details, and a lack of patient understanding.
Why is informed consent important?
It protects patient rights and ensures legal compliance.
Speaker
Laura A. Dixon recently served as the Regional Director of Risk Management and Patient Safety for Kaiser Permanente Colorado, providing consultation and resources to clinical staff. Prior to joining Kaiser, she served as the Director of Facility Patient Safety and Risk Management and Operations for COPIC from 2014 to 2020. In her role, Ms. Dixon provided patient safety and risk management consultation and training to facilities, practitioners, and staff in multiple states. Such services included creating presentations on risk management topics, assessing healthcare facilities, developing programs, and compiling reference materials that complement physician-oriented products.
Before joining COPIC, she served as the Director, of the Western Region, Patient Safety and Risk Management for The Doctors Company, Napa, California. In this capacity, she provided patient safety and risk management consultation to the physicians and staff in the western United States. Ms. Dixon’s legal experience includes medical malpractice insurance defense and representation of nurses before the Colorado Board of Nursing.
Ms. Dixon has over twenty years of clinical experience in acute care facilities, including critical care, coronary care, peri-operative services, and pain management.
As a registered nurse and attorney, Laura holds a Bachelor of Science degree from Regis University, RECEP of Denver, a Doctor of Jurisprudence degree from Drake University College of Law, Des Moines, Iowa, and a Registered Nurse Diploma from Saint Luke’s School Professional Nursing, Cedar Rapids, Iowa. She is licensed to practice law in Colorado and California.