Informed Consent and the applicable standards and guidelines can be confusing. Certain elements are required by Centers for Medicare and Medicaid (CMS) and the accrediting organizations, such as The Joint Commission (TJC) and DNV. 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. CMS notes Informed Consent is a commonly cited deficiency, which will be briefly discussed.

CMS has three different sections in the hospital CoP 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 as there are differences. Hospitals in systems should be familiar with the differences.

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 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 state law on informed consent. Many professional organizations, such as the American College of Surgeons, the 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 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.

Outline:-

Introduction to the CoPs

• Overview of Manual
• 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
• Evaluate patient rights
• Right to delegate right to another for informed decisions
• Surrogate decision makers
• Right to receive understandable information
• Policies and procedures required

Medical Records Section

• Inpatients and outpatient requirement
• Consent on chart prior to surgery
• Mandatory elements in informed consent
• Name of hospital on consent form
• Revised witness requirement
• Material risk definition
• Signature of the patient on consent form required
• Additional elements to consider on the consent form

Surgical Services Section

• Required elements
• Significant surgical tasks
• Elements of well-designed consent process
• Risks, benefits, alternatives etc.
• Consent form on chart before surgery
• Emergency exception
• Surgery definition
• Components for surgical policies and procedures
• Anesthesia consent recommended
• Surgical residents, RNFA, surgical PAs
• Important tasks related to surgery and disclosure
• Signature of the patient on consent form required
• Additional elements to consider on consent form
• LEP and Interpreters

Critical Access Hospital CoPs

• Two separate sections in 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

• RI.01.03.01 and the revised 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

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
• Individual(s) responsible for compliance with hospital regulations
• Any individual responsible for rewriting policy and procedure on informed consent.