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Universal Protocol Compliance Q&A’s

3-1-2 JCAHO compliance with the Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery became effective July 1, 2004.   The Universal Protocol encompasses the following basics:

• Pre-operative verification process

• Marking the operative site

• “Time Out” immediately before starting the procedure

  Below are some frequently asked questions and JCAHO’s response:   Q.  Isn’t this pre-operative checklist thing just another onerous Joint Commission documentation requirement?   A.  The requirement is for a “preoperative verification process.” The checklist is an example of one approach the most common one. The intent of the requirement is to ensure that all of the relevant documents are available prior to the start of the procedure and that they have been reviewed and are consistent with each other and with staffs’ understanding of the intended patient, procedure and site.  It is the process that is important, not the documentation. Surveyors will evaluate the consistency with which the preoperative verification process if performed, without mandating the use of a checklist if the organization has decided to use a different approach.   Q. What specific surgical procedures require marking of the site?   A. The Universal Protocol requirements are applicable to all operative and other invasive procedures that expose patients to more than minimal risk, including procedures done in settings other than the operating room such as special procedures unit, endoscopy unit or interventional radiology suite.  Certain routine “minor” procedures such as venipuncture, peripheral IV line placement, insertion of NG tube or Foley catheter insertion are not within the scope of the protocol.  In addition, marking the site is required for procedures involving right/left distinction, multiple structures (such as fingers and toes), or levels (as in spinal procedures).  Site marking is not required, (nor is it prohibited) for other procedures. These may include mid-line sternotomy, Cesarean Section, laparotomy and laparoscopy, cardiac catheterization and other interventional procedures for which the site of insertion is not pre-determined. However, most other procedures that involve puncture or incision of the skin, or including, but not limited to, percutaneous aspirations, biopsies, cardiac and vascular catheterization, and endoscopies are within the scope of the Universal Protocol.   Q. Do you need to mark the site for laparoscopic procedures?   A. If the target site is for organs that are paired, site marking is required to indicate the intended side, even though the site of insertion of the instrument is in the midline.   Q. What is the recommended procedure for marking spinal surgery cases?   A. For spinal surgery, we advise a two-stage marking process.  First the general level of the procedure (cervical, thoracic or lumbar) must be marked preoperatively. If the approach involves anterior versus posterior, or right versus left, then the mark must indicate this. Then, intraoperatively, the exact interspace(s) to be operated on should be precisely marked using the standard intraoperative radiographic marking technique. The requirement for the preoperative marking is based on reported cases in which a patient intended for a cervical procedure had a lumbar procedure started , and vice versa.   Q. Who should participate in the “time out” process?   A. The “time out” must involve the entire surgical team.  At a minimum, this includes active participation by the surgeon, anesthesia provider, and circulating nurse. Participation by the other members of the team, as appropriate to their involvement in the procedure, is also encouraged.  In particular, there should be no barrier to anyone speaking up if there is concern about a possible error.  To include some members of the team but not others sends the wrong message.   Q. What is meant by “active communication” as part of the “time out” process?   A. “Active communication” doesn’t necessarily mean everyone has to repeat the same information.  The members of the team may signal their agreement by a brief oral acknowledgement, a nod or some other gesture.  The point is, absence of a response should not be interpreted as agreement.   For additional information on the Universal Protocol and frequently asked questions just log onto http://www.jcaho.org.   JCAHO Statistics