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By - Laura A. Dixon, BS, JD, RN, CPHRM
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Centers for Medicare and Medicaid (CMS) and the 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.
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Laura A. Dixon, BS, JD, RN, CPHRM
Laura A. Dixon recently served as the Regional Director of Risk Management and Patient Safety for Kaiser Permanente Colorado where she provided consultation and resources to clinical staff. Prior to joining Kaiser, she served as the Director, 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 creation of and presentations on risk management topics, assessment of healthcare facilities; and development of programs and compilation of reference materials that complement physician-oriented products. Ms. Dixon has more than twenty years of clinical experience in acute care facilities, including critical care, coronary care, peri-operative services, and pain management. Prior to joining COPIC, she served as the Director, 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 for the western United States. Ms. Dixon’s legal experience includes medical malpractice insurance defense and representation of nurses before the Colorado Board of Nursing. 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.
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