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A recent wrong-side surgery in a well-known teaching hospital in Boston is a lesson for all perioperative professionals to recognize that wrong-site surgery can happen anywhere to any one.

Following a recent wrong-side surgery at Beth Israel Deaconess Medical Center (BIDMC), the surgeon reported the error to the patient (who was not seriously injured by the error), and hospital administration who sent an email to all staff explaining the error, according to a July 4th article in the Boston Globe. In the article it was reported that no time-out pause was taken to conduct final verification of the correct patient, procedure, surgical site and other important patient information, before the procedure occurred.

"When an error happens in a facility like BIDMC, it again demonstrates that medical errors can occur anywhere. Errors are usually the result of a breakdown in a process, this situation illustrates how easily medical errors can still occur even when extensive systems and safety infrastructure processes are in place," said Peter Angood, MD, FRCS(C), FACS, FCCM, chief patient safety officer and a vice president for The Joint Commission.

Angood sites BIDMC, an affiliate of Harvard Medical School, as one of the nation's most forward-thinking facilities for complying with The Joint Commission's Universal Protocol and for promoting surgical teamwork to provide optimal patient safety in operating room environments.

Time-out is a key element of The Joint Commission's "Universal Protocol For Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery™."

Between 1995 and 2007, 691 wrong-site surgeries have been reported to The Joint Commission's Sentinel Event data repository, though Angood stressed that it is likely that more wrong-site surgeries occur than just those reported to The Joint Commission. He added, "the consistently high rate of wrong-site surgeries, despite the Universal Protocol, has created significant concerns in the field." 

Improving Universal Protocol
To clarify the specific processes required to prevent wrong-site surgery and other medical errors, The Joint Commission has revised its Universal Protocol, effective Jan. 1, 2009. The revised Universal Protocol includes new and/or deleted elements of performance, as well as improvements emanating from the Standards Improvement Initiative, such as the new numbering system and minor changes to language for consistency. Released with the 2009 National Patient Safety Goals in June, the revised Universal Protocol is currently also gaining endorsement by healthcare and patient safety organizations, such as AORN.

The revisions come, in part, as the result of a Wrong Site Surgery Summit that The Joint Commission co-convened in Feb. 2007. Summit participants included surgeons, physicians, nurses, risk managers and partner organizations like AORN, who worked together to identify elements of the Universal Protocol that required clarification and improvement to enable better compliance.

These changes are part of the Universal Protocol and have also been incorporated into The Joint Commission's 2009 National Patient Safety Goals. "While the changes are not drastic, requirements have been added and deleted, so healthcare professionals are encouraged to go through the new requirements to make sure they have a process in place to verify each point of the Universal Protocol and other safety practices included in the National Patient Safety Goals," explained Louise Kuhny, RN, MPH, MBA, CIC, senior associate director of The Joint Commission Standards Interpretation Group.

Regarding the Universal Protocol, Kuhny outlined new and clarified requirements, including (but not limited to):

Pre-procedure verification process (UP.01.01.01)

• An additional verification at the time of preadmission testing and assessment, as well as anytime the responsibility for care of the patient is transferred to another member of the procedural care team (including the anesthesia providers) at the time of, and during, the procedure.
• Further identification items were also added to the verification checklist (for example, paper, electronic, or other medium such as wall-mounted whiteboard) that is used when the patient is in the pre-procedure area, immediately prior to moving the patient to the procedure room. The checklist is used to review and verify that the following items are available and accurately matched to the patient:
• Relevant documentation (for example, history and physical, nursing assessment, and pre-anesthesia assessment)
• Accurately completed, and signed, procedure consent form
• Correct diagnostic and radiology test results (for example, radiology images and scans, or pathology and biopsy reports) that are properly labeled
• Any required blood products, implants, devices and/or special equipment for the procedure

Mark the procedural site (UP.01.01.01)

• The procedure site is initially marked before the patient is moved to the location where the procedure will be performed and takes place with the patient involved, awake and aware, if possible.
• The procedure site is marked by a licensed practitioner or other provider who is privileged or permitted by the hospital to perform the intended surgical or non-surgical invasive procedure. This individual will be involved directly in the procedure and will be present at the time the procedure is performed.
• The site marking preferably includes the surgeon's or proceduralist's initials, with or without a line representing the proposed incision (or a defined alternative marking is in place) 
• The method of marking the site and the type of mark is unambiguous and is used consistently throughout the hospital.

Time-out performed immediately prior to starting procedures (UP.01.03.01)

• The time-out is conducted prior to starting the procedure and, ideally, prior to the introduction of the anesthesia process (including general/regional anesthesia, local anesthesia, and spinal anesthesia), unless contraindicated
• The time-out is initiated by a designated member of the team and is performed in a standardized fashion, as defined by the organization
• The time-out involves interactive verbal communication between all team members, and any team member is able to express concerns about the procedure verification
• There is a defined process for reconciling any differences among the team member responses
• When two or more procedures are being performed on the same patient, a time-out is performed to confirm each subsequent procedure before it is initiated

Other key changes or clarifications to National Patient Safety Goal requirements that impact the OR include the goals on infection prevention and medication reconciliation.

Read the complete 2009 National Patient Safety Goals. http://www.jointcommission.org/PatientSafety/NationalPatientSafetyGoals/

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