Centers for Medicare and Medicaid (CMS) and accrediting organizations, such as The Joint Commission (TJC) and DNV have certain elements required for informed consent. This program will discuss the current CMS hospital Conditions of Participation (CoPs), including critical access hospitals, Joint Commission, and DNV Healthcare standards, on informed consent requirements.

There are three different sections in the CMS hospital Conditions of Participation manual regarding consent. All hospitals that receive Medicare and Medicaid reimbursement must comply with these regulations and interpretive guidelines. This program will discuss the CMS requirements for hospitals and critical access hospitals.

The hospital must follow the consent regulations for all patients, not just Medicare and Medicaid patients. Failure to follow these regulations could result in the hospital being cited and/or excluded from the Medicare program. Hospitals should ensure that their policies and procedures reflect the CMS requirements and that their staff are educated on these informed consent interpretive guidelines. There are six mandatory elements and additional optional elements 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, such as 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.

Learning Objectives:-

• Recall that the CMS hospital CoP regulations have 3 separate sections on informed consent.
• Describe the six minimum requirements that are now mandatory to be any informed consent form for surgery completed at a Medicare-certified hospital.
• Discuss the CMS and accreditation organization standards applicable to your facility which 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 CoPs

• Introduction
• Informed Consent deficiencies

Patient Rights/Informed Decision Section

• Informed consent as a process
• Right to make informed decisions
• Right to be informed of health care status
• Right to refuse care
• Right to delegate right to another for informed decisions
• Policies and procedures required
• LEP and Interpreters

Medical Records Section

• Consent on chart prior to surgery
• Mandatory elements in informed consent
• Name of the hospital on the consent form
• Optional elements for an informed consent
• The signature of patient on the consent form required

Surgical Services Section

• Required elements
• Significant surgical tasks
• Elements of a well-designed consent process
• Risks, benefits, alternatives, etc.
• Material risks definition
• Important surgical tasks
• Consent form on the chart before surgery
• Emergency exception
• Anesthesia consent recommended
• Surgical residents, RNFA, surgical PAs
• Additional elements to consider on the consent form

Critical Access Hospital CoPs

• 2 separate sections in the CAH manual: clinical records and surgical services
• Consent requirements
• Significant surgical tasks
• Consent as a process
• Mandatory and optional requirements

Joint Commission Informed Consent Standards

• Record of Care and requirements
• Patient Rights and Responsibilities
• 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
• Consent on chart required before surgery

DNV Healthcare Standard on Informed Consent

Professional Organization Resources on Consent

Appendix and Resources

Who Should Attend:-

• CEO
• Compliance officer
• Chief medical officer (CMO)
• Chief nursing officer (CNO)
• COO
• Nurse Educator
• Nurses
• Nurse Directors/ Supervisors
• Nurse Managers
• Physicians
• Medical staff coordinator
• Patient safety officer
• Risk Manager
• QAPI director
• Joint Commission or DNV coordinator
• Director of health information management
• OR nurse director & nurses
• Patient Advocates