New CMS Measure & Why Informed Consent Matters

Fernanda Sobreira and Samantha Relich

A commitment to quality healthcare often means staying ahead of the curve. In his presentation on strategies for on-time, lower-risk surgeries and best practices for informed consent at Palooza 2017, Tim Kelly, Director of Taylor Healthcare dove into a new informed consent measure currently proposed by the Centers for Medicare and Medicaid Services (CMS) and some of the reasons why healthcare should be looking to improve and invest in the informed consent process.

The news about informed consent? 

On April 28 of 2017, the CMS proposed 7 new measures of the Hospital Inpatient Quality Reporting Program (IQR), including the “quality of informed consent document measure” which is still open for comments until June 13.  

The reasoning behind this measure had two major points: 

  • That comprehensive consent documents can improve patient understanding and satisfaction. 
  • That comprehensive consent documents can help patients make decisions that meet their expectations and preferences. 

Currently, according to the CMS, documents are generic, lack relevant information and are presented to patients “before the start of a procedure when they are most vulnerable and least likely to ask questions,” according to Kelly. 

Why invest in an informed consent process? 

The short answer is because informed consent processes affect so many aspects of your organization, from risk mitigation, compliance and accreditation to operational efficiency and patient safety. 

Improvements like an electronic process can help avoid forms with missing crucial information and illegible writing, while developing a standardized and thorough process can help avoid lawsuits due to inadequate informed consent. 

According to a Johns Hopkins study, 66% of the time consent of the patient is missing from the record prior to procedures, which can lead to operational deficiencies like delayed operating room start times. 

Better informed consent procedures also have a huge impact on patient safety in the case of preventing never events: wrong-patient, wrong-procedure, wrong-site surgery. In the case that these events do happen, they can be potentially disastrous to hospital reputations. According to Kelly, an effective way of avoiding these events is verify the consent form – forms that list patient, procedure and surgical site. 

Kelly left us with 3 actionable takeaways you can start doing today to improve on your informed consent process:

  1. On-time procedures: Check with your OR department and see if there were any delays where consent was involved. Work with the team to ensure you can have the documentation in front of the surgical team at an appropriate time.

  2. Minimize risk: Check your forms and add a line on surgical site and procedure. This will make it easy for patients to understand and help with good catch on procedure site.

  3. Test your process against the proposed quality measure: Analyze your existing consent forms and evaluate the timing of your consent process. Where can you make improvements?

Want to see what else we learned at Palooza ths year? Check out our post on the power of storytelling in healthcare.


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