December 8, 2008

Three more “never events” – adverse events that should ideally never happen to inpatients – for which Medicare recently proposed to hold hospitals financially responsible are:

• Wrong surgical or other invasive procedures performed on a patient;
• Surgical or other invasive procedures performed on the wrong body part; and
• Surgical or other invasive procedures performed on the wrong patient.

On December 2, 2008, the Centers for Medicare and Medicaid Services (CMS) proposed national coverage determinations (NCDs) to prevent Medicare from paying for these three clearly-preventable types of errors. CMS will accept public comments on the proposed NCDS until January 1, 2009, and will issue the final NCDs within 60 days.

Note that a growing number of private payers likewise are beginning to deny payment for Never Events. Since Medicare’s announcement that it would not allow higher payments for treating Hospital Acquired Conditions last August, Aetna, WellPoint, UnitedHealth Group, Cigna, and Blue Cross/Blue Shield have either already implemented similar policies, are testing them in specific markets, or are considering doing so.

The seriousness and methods to minimize the occurrence of wrong-site surgery are well known. Anesthesiologists participate in a “surgical pause” or “surgical time-out” in which every clinician in the operating room – physicians and nurses – verbally confirms that this is the right patient, the right procedure and the right side or site. Since July 1, 2004, the Joint Commission has required that its accredited hospitals comply with the Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery.

Yet the Joint Commission acknowledges that it learns of 8-10 new cases of wrong-site surgery (the collective name for the three categories, wrong site, wrong patient or wrong procedure) per month. At that rate, wrong-site surgery remains the most frequently reported sentinel event in the database. And those are only the voluntarily reported cases. States that maintain their own registries, e.g., Pennsylvania and Massachusetts, show monthly error rates of up to 15 or more wrong-site surgeries.

The Joint Commission has just issued a series of updated reports and a revised Universal Protocol for use starting January 1, 2009. http://www.jointcommission.org/PatientSafety/UniversalProtocol/. The revised protocol includes pre-procedure verification, procedure site marking and the time-out itself. It is the result of a 50-organization summit convened by the Commission in 2007, the resulting modifications to the Universal Protocol released in June 2008, and feedback received throughout the summer and fall. Anesthesiology was vigorously represented by Beverly Philip, M.D., advocating that:

[T]he Time Out should occur before the related anesthetic — before the patient undergoes risk from an anesthetic that may not be optimal for the true procedure needing to be done. The Time Out should occur before all preparatory processes such as positioning, prepping and draping are already completed, and while changes can still be easily made.

(Bierstein K. Preventing Wrong Site Surgery. ASA Newsl. 2007 71(8):21-23, http://www.asahq.org/Newsletters/2007/08-07/pracMgmt08_07.html). Ultimately the ASA position advanced by Dr. Philip was watered down and made optional. The Joint Commission did at least adopt the view, however, that “In recognition of the critical role of the surgeon, or individual performing procedures, as part of the procedure team, it is not allowable to conduct the time-out without him or her present.” Thus one of the recognized factors in the persistent unacceptable rate of wrong-site surgeries has been addressed.

Wrong-site surgery is among the 28 Never Events listed by the National Quality Forum, as noted in our December 1 Alert. If you have questions about implementing the Universal Protocol, ABC will be pleased to help our current and future clients. Specific questions about the proposed NCDs should be directed to Karin Bierstein, JD, MPH, Vice President for Strategic Planning and Practice Affairs. Ms. Bierstein and other ABC staff will be attending the Post-Graduate Assembly in New York this coming weekend. We hope to see many of you at our exhibit at the PGA.