Informed Consent Update; Maneuvering the Maze

Informed Consent Update; Maneuvering the Maze CMS, Joint Commission, DNV and other Standards on Informed Consent Every Hospital Should Know

Ever been confused about what standards and guidelines apply to informed consent? Do you know what elements should be in your consent form? This program will discuss the current CMS hospital Conditions of Participation (CoPs), including the critical access hospital, 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 if they are present even if the patient is competent.

It will cover the Joint Commission revised informed consent standards. This includes the requirements for discussion of recuperation.

A study found that consent forms were missing in 66% of patients in hospitals delaying 10% of surgical procedures. The researchers at Johns Hopkins found the cost of loss 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 number and types of deficiencies from CMS will be discussed.

The Centers for Medicare and Medicaid Services (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 since they are very different. Hospitals in systems should be familiar with the differences.

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 or fined.  Hospitals should ensure that their policies and procedures reflect the CMS requirements and that their staff is educated on these informed consent interpretive guidelines. There are six mandatory elements and additional ones that 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 laws on informed consent. Many professional organizations, like 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. Come join us for a fun session on making informed consent a little simpler to understand!

• 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 on 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 informed consent under federal regulations.

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
• The patient advocate asked to sign consent even if the 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 the plan of care after discharge
• Right to receive understandable information
• Policies and procedures required
• Survey procedure for the surveyor

Surgical services Section 2 CMS Hospital CoPs

• Consent form on the chart before surgery
• Emergency exception
• Short and long term risks
• Benefits
• Physician professional judgment
• Surgery definition
• The hospital must assure the consent process
• Anesthesia consent required
• Surgery consent policy requirements
• Documentation in the medical record
• Elements of the 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 (MEC) must approve a list of when consent is required
• Surveyor to interview patients on the process
• Medical record review by the surveyor

Medical Records-Section 3 CMS Hospital CoPs

• Inpatients and outpatient requirement
• Consent on the chart before surgery
• Minimum elements in the informed consent
• Name of the hospital on the consent form
• Revised witness requirement
• Material risk definition
• Signature of the patient on consent form required
• Additional elements to consider on the consent form
• Surveyor review of six charts
• Surveyor procedure

CMS Critical Access Hospital CoPs

• 2 separate sections in the CAH manual under tags 304 and 320
• 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 revised EPs and recuperation
• 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

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, QAPI director, Joint Commission or DNV coordinator, director of health information management, director of anesthesia, OR nurse director, nurses, Patient Safety Officer, Patient Advocates, Ethics Committee and others responsible for compliance with hospital regulations, and persons responsible for rewriting policy and procedure on informed consent.