Medical Mutual Insurance Company of Maine: Risk Management » Practice Tips Wrong Site, Wrong Procedure and Wrong Person Surgery

Practice Tips: Your online library of how-to guidance for operational systems and procedures.

Risk Management » Practice Tips

August 2008

Wrong Site, Wrong Procedure and Wrong Person Surgery - Prevention

Wrong-site surgery errors have been the focus of the media, the public, and the medical community for several years.

In July 2003, The Joint Commission Board of Commissioners approved the Universal Protocol for Preventing Wrong Site, Wrong Procedure and Wrong Person Surgery. The Universal Protocol was created to address the continuing occurrence of these tragic medical errors in Joint Commission accredited organizations. The Universal Protocol became effective July 1, 2004 for all accredited hospitals, ambulatory care and office-based surgery facilities.1

An AHRQ (Agency for Healthcare Research and Quality) study conducted in 2006 evaluated nearly 3 million surgeries between 1985 and 2004 and found that the number of wrong-site surgeries conducted on limbs or organs other than the spine occurred once in every 112,994 operations. Forty cases of wrong-site surgery were identified among 1,153 malpractice claims and 259 instances of insurance loss related to surgical care. Twenty-five of the cases were non-spine wrong-site surgeries, with the remainder involving surgery of the spine. Additionally, the study noted that the Joint Commission’s Universal Protocol might have prevented only 62% of the cases reviewed. 2

In January 2008, the Wall Street Journal reported that many of the large health insurance companies were adopting policies banning payment for medical care required as a result of a serious error, such as surgical site errors or procedures done on the wrong patient. Additionally, the policies are written to prevent the hospitals from billing the patient directly.3

The World Health Organization (WHO) in July 2008 developed a “surgical safety checklist” in an effort to address reducing surgical complications. This checklist and a training manual is available free-of-charge at:
http://www.who.int/patientsafety/safesurgery/tools_resources/technical/en/index.html

The following factors contribute to the increased risk of wrong-site surgery:

Failure of the surgeon to exercise due care
Assumption by members of the surgical team that someone else has confirmed the procedure, checked the location of the site, and cross-checked for accuracy
X-rays inadvertently placed backwards causing left and right sides to be reversed
Failure to establish proper controls in the surgical process
Communication issues between patient and surgeon
Having more than one surgeon involved in the procedure
Performing multiple procedures on the patient during a single surgical encounter, especially when different procedures are performed on different sides of the patient
Time pressures due to unusual start times
Pressure to decrease preoperative preparation time
Patient characteristics requiring unusual equipment setup or patient positioning on the surgical bed
Failure to include the patient and/or family members when identifying the correct site
Incomplete or inaccurate communication among members of the surgical team
Incomplete preoperative assessment of the patient

Universal Protocol 5

The Universal Protocol, developed by the Joint Commission and endorsed by 51 professional organizations, was revised in 2008. Implementation of the revisions to the Universal Protocol is required of Joint Commission accredited organizations by 2009. There are program specific versions of the protocol reflecting care administered in the hospital setting, the office based surgery setting and ambulatory health care. This practice tip will review the elements of the Universal Protocol. These elements represent patient centric strategies to assure that wrong site, wrong patient or wrong procedure events do not occur.

This Protocol applies 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 a 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).

Pre-procedure verification4
The pre-procedure verification is an ongoing process of information gathering and verification, beginning with the decision to perform a procedure, continuing through all settings and interventions involved in the pre-procedure preparation of the [patient], up to and including the time-out just before the start of the procedure. 5

The purpose of the pre-procedure verification process is to make sure that all relevant documents and related information or equipment are:

Available prior to the start of the procedure.
Correctly identified, labeled, and matched to the [patient]’s identifiers.
Reviewed and are consistent with the [patient]’s expectations and with the team’s understanding of the intended [patient], procedure, and site. 4

Missing information or discrepancies are addressed before starting the procedure. 4

Verification of the correct person, correct site and correct procedure needs to occur while the patient is awake and aware, at the following times:

At the time the procedure is scheduled
At the time of preadmission testing
At the time of admission for a procedure
Before the patient leaves the pre-procedure area or enters the procedure room
Anytime the responsibility for care of the patient is transferred to another member of the procedural care team4

Identification of the Procedure Site 5
All procedures involving incision or percutaneous puncture require that the intended site be marked.

Make the mark at or near the incision site. Do NOT mark any non-operative site(s) unless necessary for some other aspect of care.
The mark must be unambiguous (e.g., use the initials of the provider performing the procedure. Consider that “X” may be ambiguous).
The mark must be positioned to be visible after the patient is prepped and draped.
The mark must be made using a marker that is sufficiently permanent to remain visible after completion of the skin prep. Adhesive site markers are not to be used as the sole means of marking the site.
The method of marking and type of mark should be consistent throughout the organization.
At a minimum, mark all cases involving laterality, multiple structures (fingers, toes, lesions), or multiple levels (spine). For spinal procedures, intraoperative radiographic techniques are used to identify the exact vertebral level.
The person performing the procedure does the site marking.
Marking must take place with the patient involved, awake and aware, if possible.
Final verification of the site mark must take place during the “time out.”
A defined procedure must be in place for patients who refuse site marking. 4

For those situations listed below, the development of an alternative process for site marking needs to occur.

Interventional cases for which the catheter/instrument insertion site is not
predetermined (e.g., cardiac catheterization).
Teeth—indicate operative tooth name(s) on documentation OR mark the operative tooth (teeth) on the dental radiographs or dental diagram.
Premature infants, for whom the mark may cause a permanent tattoo. 4

Perform a time-out immediately prior to the start of a procedure 4

The purpose of the time-out immediately before starting the procedure is to conduct a final assessment that the correct patient, site, positioning, and procedure are identified and that, as applicable, all relevant documents, related information, and necessary equipment are available. 5

The time-out is consistently initiated by a designated member of the team and includes active communication among all relevant members of the procedure team. It is conducted in a standardized fail-safe mode (that is, the procedure is not started until all questions or concerns are resolved). The time-out needs to be conducted with all other activities in the room suspended (taking patient safety into account.) This allows all team members to be focused on the intent of confirming correct patient, procedure, site and other critical elements. Elements of the time-out are clearly documented in the medical record. 4

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. 4
The time-out has the following characteristics:
- It is standardized.
- It is initiated by a designated member of the team.
- It involves the immediate members of the procedure team including the proceduralist(s), the anesthesia providers, the circulating nurse, the
  operating room technician, and other active participants as appropriate for the procedure, who will be participating in the procedure at its inception.
- It involves interactive verbal communication between all team members, and any team member is able to express concerns about the procedure verification.
- It includes a defined process for reconciling differences in responses. 4
The time-out includes the following:
- Correct patient identity
- Confirmation of the correct side and site are marked
- Accurate consent form
- Agreement on the procedure
- Correct patient position
- Relevant imaging studies are properly labeled
- Safety precautions pertinent to the patient4

WHO checklist

The World Health Organization created a checklist of steps to be consistently followed by the surgical team to decrease the incidence of avoidable risks that face the surgical patient. “Each safety check has been included based on clinical evidence or expert opinion that its inclusion will reduce the likelihood of serious, avoidable surgical harm and that adherence to it is unlikely to introduce injury or unmanageable cost.” 5

The WHO checklist provides steps to be followed at various stages in the care of the surgical patient. These stages (pre-anesthesia induction, after induction but before start of the case, and immediately after wound closure) have easy to follow steps that when evaluated, will reduce risk exposure to the commonly occurring events that happen at each phase of anesthesia care. The implementation manual provides detailed examples of how to implement utilization of the checklist during each stage. The checklist reinforces the team approach to safe surgical care and fosters the interdisciplinary approach at each step. 5

Pre-Op Meetings

A recent study by Johns Hopkins suggests that a two-minute meeting of all the members of the surgical team, immediately prior to the start of the procedure, can reduce the incidence of wrong-site, wrong patient surgery. “During the two-minute briefing, all members of the OR team state their name and role, and the lead surgeon identifies and verifies critical details, including the patient's identity, the surgical site, and patient safety concerns. The briefing is conducted after the patient has been given anesthesia and prior to incision.”6

Conclusion
Regardless of the approach implemented to insure surgical safety in preventing wrong site, wrong procedure and wrong person surgery, it is imperative that processes be developed and utilization of the expected guidelines be monitored. Wrong-site surgeries are a rare occurrence but when they occur, they have devastating impact on not only the patient and family but the members of the surgical team as well. 5

To access the Joint Commission’s universal protocol: http://www.jointcommission.org/PatientSafety/UniversalProtocol/

To access the WHO checklist: http://www.who.int/patientsafety/safesurgery/tools_resources/download/en/index.html

Sources:

http://www.jointcommission.org/PatientSafety/UniversalProtocol/up_facts.htm
AHRQ Study Finds Wrong-site Surgery Rare and Preventable. Press Release, April 17, 2006. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/news/press/pr2006/wrongsitepr.htm
http://online.wsj.com/article/SB120035439914089727.html?mod=googlenews_wsj
http://www.jointcommission.org/PatientSafety/UniversalProtocol/
http://www.who.int/patientsafety/safesurgery/tools_resources/SSSL_Manual_finalJun08.pdf
http://www.forbes.com/forbeslife/health/feeds/hscout/2007/01/29/hscout601326.html
Johns Hopkins Medical Institutions (2007, January 24). RX For Wrong-site Surgery: Two Minutes Of Conversation. ScienceDaily.
Incidence, Patterns, and Prevention of Wrong-Site Surgery : Mary R. Kwaan, MD, MPH; David M. Studdert, LLB, ScD; Michael J. Zinner, MD; Atul A. Gawande, MD, MPH: Arch Surg. 2006;141:353-358.
Wrong-Side/Wrong-Site, Wrong-Procedure, and Wrong-Patient Adverse Events Are They Preventable? :Samuel C. Seiden, MD; Paul Barach, MD, MPH :Arch Surg. 2006;141:931-939.

Medical Mutual's "Practice Tips" are offered as reference information only and are not intended to establish practice standards or serve as legal advice. MMIC recommends you obtain a legal opinion from a qualified attorney for any specific application to your practice.