Informed Consent Requirements: CMS, Joint Commission and DNV Standards for Hospitals

Informed consent is a critical compliance requirement in healthcare, ensuring that patients understand and agree to medical treatment before it is performed. Hospitals must comply with regulations from the Centers for Medicare & Medicaid Services (CMS), accreditation bodies, and state laws.

Failure to meet these requirements can result in survey deficiencies, financial penalties, and legal risks.

What is Informed Consent?

Informed consent is not just a signed document—it is a process.

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:

• Consent must be obtained before procedures
• Must be documented in the medical record
• Policies must define when consent is required
• Staff must follow standardized processes

CMS requires informed consent documentation across multiple CoPs sections.

Mandatory Elements of a Valid Consent Form

A compliant consent form must include:

• Patient identification
• Procedure name
• Responsible practitioner
• Risks, benefits, and alternatives
• Patient signature with date/time

These elements must be present before procedures are performed.

Joint Commission Standards

The Joint Commission emphasizes:

• Patient rights
• Clear communication
• Ongoing consent process
• Policy consistency

DNV Healthcare Requirements

DNV Healthcare focuses on:

• Documentation accuracy
• Alignment with CMS standards
• Survey readiness

Recent CMS Updates

Recent CMS guidance highlights:

• Consent required for sensitive procedures
• Applies even to student involvement
• Patients have the right to refuse

Hospitals must ensure consent is obtained and documented in all cases.

Common Deficiencies

• Missing consent forms
• Incomplete documentation
• Lack of staff training
• Consent is treated as a form, not a process

Why Informed Consent Matters

Failure to comply can lead to:

• Survey citations
• Legal liability
• Delayed procedures
• Loss of reimbursement

Best Practices for Hospitals

• Standardize consent policies
• Train staff regularly
• Audit consent documentation
• Ensure patient understanding
• Keep consent as an ongoing process

• 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.

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 the 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 the 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 a 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 the 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

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, QAPI director, Joint Commission or DNV coordinator, director of health information management, director of anesthesia, OR nurse director, nurses, Patient Safety Officer, Patient Advocates, Ethics Committee and others responsible for compliance with hospital regulations, and persons responsible for rewriting policy and procedure on informed consent.

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?

Documentation, policies, and patient understanding before procedures.

Is informed consent just a form?

No, it is a continuous communication process.

What are common consent mistakes?

Missing forms, incomplete documentation, and poor communication.

Why is informed consent important?

It protects patient rights and ensures compliance.