Informed Consent Update; Maneuvering the Maze 2021: 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 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.

In addition to 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 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, 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.

This program will cover the basics of documentation, including “why nursing documentation is so important” and “what”. Principles of the documentation set out by ANA, expectations from CMS and Joint Commission regarding documentation will be covered. Additionally, legal implications surrounding documentation will be addressed.

Included in the discussion will be case studies that present why nursing documentation is so important and how the content, or lack thereof, resulted in either a decision for the healthcare provider or the plaintiff.

• Recall ANA’s principles for why nursing documentation is so important.
• Describe the regulatory and professional requirements and expectations for documentation.
• Recall the basic requirements for documentation of clear, accurate, timely, and complete.
• Recall why nursing documentation is so important in preventing and/or defending medical malpractice cases.

This program is a must-attend for any hospital especially critical access hospitals. This is because it is one of only three sections with a CMS worksheet. It will also discuss the revised CMS hospital QAPI standards. There is a high number of deficiencies and these will be discussed. There are over 2,158 deficiencies and many of these relate to patient safety.

This program will also cover the final changes to QAPI that were effective November 29, 2019. CMS implements similar QAPI standards for critical access hospitals in the final Hospital Improvement Rule so all CAHs should listen to this presentation. Critical access hospitals (CAHs) have an additional 18 months to implement since this rewrites all the CAHs QAPI standards. There are ten new CAH QAPI provisions starting at tag 1300.

If CMS showed up at your door tomorrow would you be able to show that you are in compliance with the QAPI standards? Have you implemented the 2020 changes? Did you know there is a section in the QAPI standards that address patient safety and risk management? It requires hospitals to have 3 root cause analyses. Hospitals were also cited for not having a number of required policies and procedures.

The QAPI (Quality Assessment and Performance Improvement) worksheet is designed to help surveyors assess compliance with the hospital CoPs for QAPI.  The worksheet is used by State and Federal surveyors on all survey activity in hospitals when assessing compliance with the QAPI standards including validation and certification surveys. CMS may also just show up at your door to assess the three worksheets.

Every hospital that accepts Medicare and Medicaid must be in compliance. The CMS QAPI worksheet is an excellent communication tool so that the hospital will know what the expectations are from CMS. QAPI is an important issue to CMS and an increased area of focus.

This program will discuss the memo that CMS issued regarding the AHRQ common formats. CMS states that there are several reports that show that adverse events are not being reported. In fact, it is estimated that 86% of adverse events are never reported to the hospital’s PI program. Performance improvement is very important to CMS and the hospital conditions of participation require many things to be measured.

• Recall that CMS has a worksheet on QAPI
• Describe that there is a section on QAPI in the CMS hospital CoP manual that any hospital that accepts Medicare or Medicaid reimbursement must follow
• Discuss that the Board is ultimately responsible for the QAPI program and must ensure there are adequate resources for PI
• Recall that hospitals are receiving a high number of deficiencies in QAPI
• Discuss that CMS has completely rewritten the QAPI requirements for CAHs

Hospital Ligature Risks Assessment Webinar : Ensuring Compliance with the CMS Hospital CoPs and TJC Requirements 2021. This CMS ligature risk 2020 was a hot area of discussion already and still continues to be the same as there is a lot of survey activity around the prevention of suicidal patients from harm or strangulation. The Joint Commission announced that this is one of the four top areas of focus and their data shows that hospitals are receiving many RFIs in this area. The Centers for Medicare and Medicaid Services (CMS) has promulgated requirements for hospitals to prevent hospital ligature risk and self-harm from patients that are suicidal. A 13-page memo was issued and the hospital manual was amended. Any hospital that received Medicare, which is most hospitals in America, must implement these changes for all patients. This ligature risk assessment webinar will also discuss the CMS proposed 15-page guidelines changes in cms ligature risk 2020.

CMS amends tag numbers 144 inpatient rights and tag 701 in facility services. This discusses what units need to be ligature resistant. It covers what patient assessments must be done and what should be in the environmental assessments. It discusses education and policy and procedure requirements. If you have a highly suicidal patient and the room is not ligature resistant do you have a 1:1 sitter? Hospitals that do not will need to change their policy and process and budget for this.

Joint Commission has 16 requirements to ensure compliance with their standards. We will discuss these in detail in this ligature risk assessment and include psych hospital, behavior health units, general acute care inpatient units, outpatient units, and emergency departments. The zero suicide campaign will be discussed. The TJC sentinel event alerts on suicide, NPSG 15 and final changes July 1, 2019, and Frequently Asked Question (FAQ) on ligature risk will be covered. This includes one related to whether video monitoring is ever allowed. Again, the Joint Commission announced that this is one of four areas of focus so hospitals need to have this issue on their radar screen and be prepared.

Resources will be provided in this ligature risk assessment webinar. Tools to assess patients to determine if they have suicidal ideations will be included.

of Ligature Risk Assessment Webinar

• Recall that CMS now has two tag numbers that set forth requirements to prevent ligature and suicide risks for patients with suicidal ideations
• Discuss that the Joint Commission has requirements for hospitals to follow to prevent patients from self-harm including hanging or strangulation
• Describe that CMS recommends education in orientation, when policies change and every two years
• Recall that CMS has proposed guidelines

The Centers for Medicare and Medicaid Services (CMS) hospital CoPs have a section on the medical staff. This includes information on credentialing and privileging requirements, implementing Medical Staff (MS) bylaws and rules and regulations, hospitals in systems.

This program is timely because of the increased number of deficiencies received which are over 2,180. There are three significant changes that became effective November 29, 2019, to the CoPs under the transparency bill, discharge planning, and hospital improvement rule which will be discussed. This includes changes to the history and physicals for healthy patients having outpatient procedures and changes to the autopsy rules.

Many changes were made in April of 2015 and some hospitals are still struggling to ensure compliance. CMS allows a hospital system to share a medical staff which CMS refers to as a unified and integrated medical staff. 

The Medical Staff can credential the dietician to order the diet and the RD can be a member of the medical staff or just C&P without being a member of the Medical Staff. The board and Medical Staff sections will be discussed in detail.

There will also be a concurrent discussion of TJC standards for medical staff.

• Discuss that CMS has a section related to the medical staff in the hospital CoPs
• Describe that hospitals can have a separate medical staff or a unified shared integrated medical staff
• Recall that CMS will allow the Medical Staff to credential qualified dieticians to order the patient’s diet if state law allows
• Describe the requirements for a medical staff under TJC standards