Further Alignment between CMS and Joint Commission announced regarding Restraint and Seclusion Use and Informed Consent
May 22, 2007In the May 2007 issue of Joint Commission Online http://www.jointcommission.org/Library/jconline/jo_05_07.htm, The Joint Commission announced a revision to standard PC.12.90 to align their standard with changes the Centers for Medicare and Medicaid Services (CMS) made in December 2006 regarding who may conduct the "in-person" or "face-to-face" evaluation of the patient when restraint or seclusion is initiated for management of violent or self-destructive behavior.
Prior to this change, these episodes of restraint or seclusion use had to be reviewed within one hour by a physician or "other licensed independent practitioner (LIP.)" In December, CMS changed the rule to allow a trained registered nurse or physician assistant to conduct the in-person evaluation so long as the physician or other LIP treating that patient is consulted as soon as possible. The Joint Commission is now altering PC.12.90 to conform to the CMS rule. While the Joint Commission change is said to be effective immediately, we should be on the lookout for the official announcement and final language in the June issue of Joint Commission Perspectives.
The process of documenting informed consent is a second topic where the CMS and The Joint Commission have narrowed variation in their rules and standards.
After more than three years in development, the CMS in April 2007 finally announced updated interpretive guidelines (IG) for the informed consent requirements under the Medicare Conditions of Participation (CoP) for hospitals, and in doing so relaxed existing and previously announced changes to the guidelines. The new guidelines may be accessed at http://www.cms.hhs.gov/SurveyCertificationGenInfo/downloads/SCLetter07-17.pdf
Unlike The Joint Commission, CMS has always required the medical record of a patient undergoing a procedure or treatment that requires patient consent to include a properly executed consent form. Previous CMS guidelines even specified the content of the form, and the guidelines under development since May 2004 were to become even more prescriptive.
For example, forms would need to include the specific risks and consequences of the procedure and the risks and consequences if no treatment is rendered. Any alternative procedures and treatments would need to be noted as would--and this was a ringer for teaching hospitals--the names of all practitioners performing the procedure or important aspects of the procedure, including the names and specific significant surgical tasks to be conducted by practitioners other than the primary surgeon/practitioner. Significant surgical tasks included opening and closing, harvesting grafts, dissecting tissue, removing tissue, implanting devices, and altering tissues. Finally, the signature of the person witnessing the consent had to be a "professional" and the name and signature of the person who explained the procedure to the patient had to be noted on the form.
Now that CMS has published its latest guidance to state survey agency directors, we are happy to find that the guidelines no longer require that hospital consent forms list the risks and consequences of the procedure and the risks and consequences if no treatment is rendered. Similarly, the guidelines no longer require that hospital consent forms list any alternative procedures and treatments. Most importantly, the guidelines no longer require that hospital consent forms include the names of all practitioners performing the procedure or important aspects of the procedure, or the names and specific significant surgical tasks that will be conducted by practitioners other than the primary surgeon/practitioner. Finally, the guidelines no longer require that a "professional" witness the consent.
With these revisions, CMS is now in greater alignment with Joint Commission standard RI.2.40 that emphasizes having policy and procedure aimed at the process of obtaining informed consent. Rather than requiring a consent form per se, The Joint Commission simply requires that the process of obtaining informed consent is documented in a manner consistent with policy and procedure, which could include use of a consent form, or use of a progress note or dictated preprocedure note (perhaps as part of the history and physical).
Regardless of where the informed consent process is documented, the record should include at a minimum the name of the hospital where the procedure is to take place along with the name of the specific procedure for which consent is being given and the name of the responsible practitioner who is performing the procedure. The record should include (preprinted and signed, or hand-written/dictated and signed) what I call an attestation or statement from the "first person" perspective of the responsible practitioner that says something like:
"I have discussed and explained to the patient (or the patient's legal representative) the nature of the planned procedure, including the anticipated benefits and the likelihood of achieving these benefits, the material risks involved including those that might occur during recuperation, alternatives therapies, and likely consequences of non-treatment, I have accepted and answered their questions to their satisfaction, and I have obtained consent to proceed as planned."
As with any chart entry, this entry should be dated and signed by its author prior to the procedure.
So is a form required? Not technically, although hospital risk managers and corporate counsel usually also like to see a signature of the patient or the patient's legal representative attesting to their having received this information prior to the procedure and having granted consent, thus a form is often the most practical means by which to record this data. The form should then be dated, timed, and signed by the person witnessing the patient or the patient's legal representative signing the consent form. And of course applicable state law should be studied to determine if your state requires a form or "content" above and beyond these CMS and Joint Commission requirements.
Just as a reminder, in addition to our work with hundreds of clients across the country providing ongoing assistance aimed at achieving sustained execution and constant survey readiness, The Greeley Company consultants are also expert in helping you dig your way out of an adverse accreditation decision (Conditional or Preliminary Denial of Accreditation) or simply in helping you reduce the number of RFIs post-survey but prior to your submitting Evidence of Standards Compliance and Measures of Success at the 45-day mark. For more information please call our Director of Client Relations, Stacy Koch, at 888-749-3054, ext. 3193 or click here.
John Rosing, MHA, FACHE
Practice Director, Accreditation and Regulatory Compliance
The Greeley Company
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