Centers for Medicare and Medicaid (CMS) and the accrediting organizations have certain elements required for informed consent. This program will discuss the current CMS hospital Conditions of Participation (CoPs).
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.
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.
OBJECTIVES
- Recall that the CMS hospital CoP regulations have three 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 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
- 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 hospital on consent form
- Optional elements for an informed consent
- Signature of patient on consent form required
Surgical Services Section
- Required elements
- Significant surgical tasks
- Elements of well-designed consent process
- Material risks definition
- Important surgical tasks
- Consent form on chart before surgery
- Emergency exception
- Anesthesia consent recommended
- Surgical residents, RNFA, surgical PAs
- Additional elements to consider on consent form
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
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
- Director of health information management
- OR nurse director & nurses
- Patient Advocates