The Association of PeriOperative Registered Nurses (AORN) is now in the midst of performing an evaluation of the Universal Protocol, which was created and implemented to eliminate wrong-site, wrong-procedure, and wrong-patient surgery.
The July 2003 Universal Protocol for Preventing Wrong Site, Wrong Procedure and Wrong Person Surgery from the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) was created in direct response to the ongoing incidence of wrong-site, wrong-procedure, and wrong-patient surgeries. The protocol actually became required on July 1, 2004, for all healthcare organizations accredited by the Joint Commission. It was based in part on the Joint Commissions 2003 and 2004 National Patient Safety Goals.1
The main elements of the protocol include the following:
1. A pre-operative verification process
2. Marking the operative site
3. Taking a time out immediately before the procedure begins
4. Adapting the requirements to non-operating room settings, to include bedside procedures.
Any of these events the wrong site, wrong procedure, or wrong patient are considered sentinel events by JCAHO. A sentinel event is defined as an unexpected occurrence involving death or serious physical or psychological injury.
When the Joint Commission realized that these events were still occurring even after sentinel event alerts issued in 1998 and 2001, it convened a wrong-surgery summit. The summit was used as an opportunity for multiple organizations and associations to come to a consensus on a Universal Protocol for all healthcare settings. The eventual protocol was endorsed by more than 50 professional associations and organizations, including: the Agency for Healthcare Research & Quality, the American Academy of Pediatrics, the American Association of Nurse Anesthetists, the American College of Surgeons, the American Hospital Association, the American Medical Association, the American Nurses Association, the American Society of Anesthesiologists, the American Society of General Surgeons, the Association of periOperative Registered Nurses, and the National Patient Safety Foundation.
The Universal Protocol states its purpose very simply: Wrong-site, wrong-procedure, wrong-person surgery can be prevented. The Universal Protocol has established clear procedures to ensure that the right patient is the one undergoing the procedure. It is essential to utilize multiple, complementary strategies, the protocol points out, to ensure overlap.
Joint Commission-accredited organizations are required to follow the Universal Protocol for patients having operative or other invasive procedures.
AORN is evaluating the Universal Protocol to establish what factors promote the use of the protocol, as well as which factors serve as obstacles to its execution. There will be a second summit on wrong-site surgery held later this year, during which the results of the evaluation will be offered for discussion.
Data from individual participants, which is still being collected, will be aggregated, so that no responses will be linked to an individual participant in the survey. To access the survey, visit www.questionpro.com/akira/TakeSurvey?id=570034.
The reason for the evaluation is that these sentinel events may still occur, and not all medical professionals are instituting the time out as is recommended. Deborah F. Mulloy, MSN, CNOR, of Massachusetts General Hospital, and a perioperative education consultant for AORN, will be performing a dissertation study on the results of the Universal Protocol, and will also evaluate the effect of the AORN Correct Site Surgery Tool Kit on implementation of the protocol.
With any new protocol, it is critical to evaluate its effectiveness and how well it supports practice, Mulloy observes. The Universal Protocol is supported on the intellectual basis. However, in practice, distractions can occur, and there is only one recent study (Kwaan et al 2006) about it, which suggests that the Universal Protocol is effective in approximately two-thirds of the cases of wrong-site surgery.
Since the protocol is not always being followed, AORN wants to ascertain how to get physicians, nurses, and other healthcare workers to fully observe the Universal Protocol. The association is not in a position to enforce compliance, Mulloy points out, but, she says, They can recommend practices based on research and standards and encourage members to follow them. In addition, they can provide supportive materials to members, as in this case the Correct Site Surgery Tool Kit. Professionals have an obligation to read and follow the best practices every day.
There are two simple steps that can help facilitate the use of the protocol, she adds teamwork and communication. Everyone needs to participate, and no one should believe they are exempt from the process, she says.
The term everyone includes surgeons, nurses, and other support staff even if they think they dont need to follow the guidelines. They must be re-educated to understand that JCAHO certification requires this participation in the time out, with only a few exceptions, which are clearly noted in the sample hospital protocol (see references below).
My dissertation study has two aims: to determine if there has been a change in the incidence of wrong-site surgery during the period from January 2000 through July 2006, and to evaluate the effect of the AORN Correct Site Surgery Tool Kit on implementation of the Universal Protocol for wrong-site surgery, Mulloy explains. A survey research design will be used to evaluate the effect of the AORN Correct Site Surgery Tool Kit on implementation of the Universal Protocol for Preventing Wrong Site, Wrong Patient, Wrong Procedure SurgeryTM, and to document the incidence of Wrong Site Surgery.
The Correct Site Surgery Tool Kit from AORN is offered to assist healthcare facilities in observing the Universal Protocol for preventing wrong site/procedure/ patient surgery.
The tool kit contains multiple resources for educating medical staff about the Universal Protocol and to assist in its implementation throughout the healthcare facility. According to AORN, it includes the following components:
- An educational program on CD-ROM ¡ A pocket reference card (in pdf form) outlining all of the steps necessary to promote patient identification, site marking, and the time out before surgery commences
- A template (in pdf form) for a policy to assist healthcare providers in developing a facility policy for applying the Universal Protocol
- Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery and Guidelines for Implementing the Universal Protocol
- Frequently asked questions (in pdf form) from the Joint Commission and AORN
- Letters to nurses, physicians, facility chief executive officers, and healthcare risk managers, encouraging standard implementation of the Universal Protocol throughout all facilities
- Information for patients (in pdf form) about the Universal Protocol and healthcare safety
- Additional resources regarding correct-site surgery Some of the steps within the universal protocol address previous issues with marking the operative site, for example. On premature infants, the marking can cause permanent tissue discoloration, so the protocol is exempted in this cohort.
The Joint Commissions guidelines for implementing the Universal Protocol state that additional exceptions to marking include single-organ cases (such as a caesarean section or cardiac surgery); interventional cases in which the catheter/instrument insertion site is not predetermined (such as cardiac catheterization); and teeth (but the operative tooth name(s) must be noted on documentation, or the operative tooth must be marked on the dental radiographs or dental diagram).
When the correct person, procedure, and site are verified before the surgery, this must be done multiple times when the procedure is first scheduled, at the time of the patients admission, any time the patients care is transferred to another caregiver, and before the patient leaves the preoperative area or enters the operating room. The patient should be involved, awake, and aware, if this is possible, so that he or she can immediately point out discrepancies or incorrect information about the procedure.
When the operative site is marked, it should be marked at or near the incision site, not on a nonoperative site. And the markings should not be ambiguous. An x could indicate Cut here or the opposite, Dont touch. Instead, the Joint Commission recommends utilizing initials or a Yes to indicate where the incision should go.
Additionally, the mark should be visible even after the patient is prepped and draped, and should made with a permanent marker or one that is still visible after the skin has been prepped. Specifically, the Joint Commission says, Adhesive site markers should not be used as the sole means of marking the site.
Not only that, but the entire healthcare facility must utilize the same method and type of marking throughout the building or system.
At a minimum, mark all cases involving laterality, multiple structures (fingers, toes, lesions), or multiple levels (spine), the protocol says. In addition to pre-operative skin marking of the general spinal region, special intraoperative radiographic techniques are used for marking the exact vertebral level.
Site marking should be done by the person performing the procedure, and must take place with the patient awake, aware, and involved. There must still be a final verification of the site mark during the time out.
In addition, the healthcare facility should have a defined procedure in place in case a patient refuses site marking.
The time out must take place in specific locations and at multiple times, according to the protocol. It must be conducted in the procedure area just before the surgery begins, and must involve the entire operative team. At a minimum, it must be documented, involve active communication, and must include a correct recognition of patient identity, side and site of surgery, and procedure type, as well as correct patient position and availability of required implants and special equipment or requirements for the procedure.
There should also be a system in place for resolving differences in staff responses during the time out.
If there is a non-OR setting being used for the procedure, then the following procedures apply:
- Site marking for any procedure with laterality, multiple structures or levels
- Verification, site marking, and time out procedures that are consistent throughout the facility
Exceptions apply in the following case: Site marking is unnecessary when the individual performing the procedure is in continuous attendance with the patient from the decision to do the procedure, to patient consent, through the procedure itself. However, the time out verification still must be performed.2
A sample of a hospital internal policy on the Universal Protocol can be found at: www.aorn.org/toolkit/pdf/PolicySample.pdf, and letters for nurses, physicians, and other medical staff emphasizing the important of implementation are available at www.aorn.org/toolkit/letters.asp .
JCAHO lists its expectations for implementation of the Universal Protocol at www.jointcommission.org/NR/rdonlyres/DEC4A816-ED52-4C04-AF8C-FEBA74A732EA/0/up_guidelines.pdf
Information on patient safety is available at:
- Agency for Health Care Research and Quality www.ahrq.gov4
- Association of periOperative Registered Nurses (AORN) Patient Safety First www.patientsafetyfirst.org
- Institute for Safe Medication Practices www.ismp.org
- Institute of Medicine (IOM) www.iom.edu
- Joint Commission on Accreditation of Health Care Organizations (JCAHO) www.jcaho.org/index.htm
- National Patient Safety Foundation www.npsf.org
- Partnership for Patient Safety www.p4ps.org/frame.html
- Quality Health Care www.qualityhealthcare.org/ihi
- The Anesthesia Patient Safety Foundation www.gasnet.org/societies/apsf/
- The Institute of Healthcare Improvement www.ihi.org/
- The Leapfrog Group for Patient Safety www.leapfroggroup.org
- The National Quality Forum www.qualityforum.org
- The Quality Interagency Coordination Task Force (QuIC) www.quic.gov/index.htm
- VA National Center for Patient Safety www.patientsafety.gov