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CMS, Joint Commission, DNV and Other Standards on Informed Consent Every Hospital Should Know
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
- Patient advocate asked to sign consent even if 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 plan of care after discharge
- Right to receive understandable information
- Policies and procedures required
- Survey procedure for surveyor
Surgical services Section 2 CMS Hospital CoPs
- Consent form on chart before surgery
- Emergency exception
- Short and long term risks
- Benefits
- Physician professional judgment
- Surgery definition
- Hospital must assure consent process
- Anesthesia consent required
- Surgery consent policy requirements
- Documentation in medical record
- Elements of 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 must approve list of when consent is required
- Surveyor to interview patients on process
- Medical record review by surveyor
Medical Records-Section 3 CMS Hospital CoPs
- Inpatients and outpatient requirement
- Consent on chart prior to surgery
- Minimum elements of informed consent
- Name of hospital on consent form
- Revised witness requirement
- Material risk definition
- Signature of patient on consent form required
- Additional elements to consider on consent form
- Surveyor review of six charts
- Surveyor procedure
CMS Critical Access Hospital CoPs
- 2 separate sections in CAH manual
- 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 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
Additional Resources Slides Provided on
- AAAHC and AAAASF Standards on Consent
- AOA HCFA Standard on Informed Consent
Overview of the webinar
Ever been confused about what standards and guidelines apply to informed consent? This program will discuss the current CMS hospital Conditions of Participation (CoPs), Joint Commission and DNV Healthcare standards on informed consent requirements. It will include some confusing CMS changes such as having a patient advocate sign the consent form when present even if the patient is competent.
It will cover the Joint Commission informed consent standards. This program will also discuss standards on consent for research. Not doing this right can also cost hospitals a lot of money. A recent study found that consent forms were missing in 66% of patients delaying 10% of surgical procedures. The researchers at Johns Hopkins found the cost of lost of misplaced consent forms cost hospitals $580,000 a year. Besides being a financial issue CMS, TJC, DNV Healthcare and other accreditation organizations are scrutinizing the standards. A memo by CMS showed this is a common deficiency among hospitals.
The Centers for Medicare and Medicaid Services (CMS), has three different sections in the hospital CoP manual regarding Patient Rights and Informed Consent. All hospitals that receive Medicare and Medicaid reimbursement must comply with these interpretive guidelines. This program will discuss the CMS requirements for hospitals and critical access hospitals since they are very different.
The hospital must follow the consent regulations for all patients and not just Medicare and Medicaid hospitals. Failure to follow these regulations could result in the hospital being excluded from the Medicare program. Hospitals should ensure that their policies and procedures reflect the CMS requirements and that their staff is educated their staff on these informed consent interpretive guidelines. There are six mandatory elements and additional ones which are optional 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, like 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. Come join us for a fun session on making informed consent a little simpler to understand!
Who should attend?
- 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
- PI Director
- Joint Commission or DNV Coordinator
- Director of Health Information Management
- Director of Anesthesia
- Pastoral Care
- Patient Advocates
- Ethics Committee
- Others responsible for compliance with hospital regulations and persons responsible for rewriting policy and procedure on informed consent
Why should you attend?
- 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 in 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 an informed consent under federal regulations
Faculty - Ms.Sue Dill Calloway
Sue Dill Calloway, R.N., M.S.N, J.D. is a nurse attorney and President of Patient Safety and Healthcare Consulting and Education. She is also the past Chief Learning Officer for the Emergency Medicine Patient Safety Foundation and a board member. She was a director for risk management and patient safety for five years for the Doctors Company. She was the past VP of Legal Services at a community hospital in addition to being the Privacy Officer and the Compliance Officer. She worked for over 8 years as the Director of Risk Management and Health Policy for the Ohio Hospital Association. She was also the immediate past director of hospital patient safety and risk management for The Doctors Insurance Company in Columbus area for five years. She does frequent lectures on legal, patient safety, and risk management issues and writes numerous publications.
Sue has been a medico-legal consultant for over 30 years. She has done many educational programs for nurses, physicians, and other healthcare providers on topics such as nursing law, ethics and nursing, malpractice prevention, HIPAA medical record confidentiality, emergency department patient safety and risk, EMTALA anti-dumping law, Joint Commission issues, CMS issues, documentation, medication errors, medical errors, documentation, pain management, federal laws for nursing, sentinel events, MRI Safety, Legal Issues in Surgery, patient safety and other similar topics. She is a leading expert in the country on CMS hospital CoPs issues and does over 250 educational programs per year. She was the first one in the country to be a certified professional in CMS. She also teaches the course for the CMS certification program.