Patient Safety Bulletin Number 1

Patient Safety Bulletin Number 1: Eliminating Wrong Site Surgery

A Joint Statement of the American Academy of Ophthalmology , the
American Society of Ophthalmic Registered Nurses and the
American Association of Eye and Ear Hospitals

Purpose and Background for Patient Safety Bulletins

In 1999, The Institute of Medicine (IOM) of the National Academy of Sciences, issued its report, To Err is Human: Building a Safer Health System.¹ The report brought increased national focus to issues regarding patient safety, stimulating public and private initiatives to tackle underlying systematic errors in health care delivery. The IOM outlined five major goals: establish a national focus for leadership and knowledge, identify and learn from errors, pass legislation to protect a voluntary reporting system, set performance standards and expectations for safety, and implement safety systems in health care organizations. This report also recommended the establishment of a national focus for leadership and knowledge.

In 1999, the National Patient Safety Foundation approved an Agenda for Research and Development in Patient Safety. The National Patient Safety Foundation’s agenda defines patient safety as " the avoidance, prevention and improvement of adverse outcomes or injuries stemming from the processes of health care. Safety emerges from the interaction of the system’s components; it does not reside in a person, device or department. Improving safety depends on learning how safety emerges from interactions of the components. Patient safety is a subset of health care quality."²

The American Academy of Ophthalmology, representing over 95% of practicing ophthalmologists in the United States, is committed to promoting high-quality eye care and its continuous improvement. The AAO supports the IOM’s goal to reduce medical errors and to improve safety of health care. The AAO also supports the National Patient Safety Foundation’s mission to improve health care safety by studying how errors occur and implementing safeguards. To cultivate a climate of learning about incidents and how to implement systems that will advance patient safety, the Academy is launching this small series of Patient Safety Bulletins to increase the visibility of patient safety and to inform ophthalmologists of systematic practices that can prevent errors from occurring.

The Academy is committed to improving patient care through its ongoing quality of care activities. These include the evidence-based development and dissemination of clinical practice guidelines, ophthalmic technology assessments, and complementary therapy assessments, collection of outcomes and performance measures, and development of a standard clinical reference terminology and digital imaging standards to improve access to timely and comprehensive information for medical decisionmaking. The American Society of Ophthalmic Registered Nurses (ASORN) and the American Association of Eye and Ear Hospitals (AAEEH) are collaborative partners with the Academy’s commitment to quality patient care and its ongoing quality of care activities. ASORN is a society of registered nurses whose mission is to foster excellence in ophthalmic patient care and to support the ophthalmic team through individual development, education, and evidence-based practice. AAEEH is composed of domestic and international institutions, which are dedicated to quality medicine, research, education and surgical excellence.

Wrong-Site Surgery: Definition of the Problem

Wrong-site surgery is a problem that occurs across surgical specialties, and is usually caused by a breakdown of the system or lack of a system to verify the site of surgery. In research performed by the Physician Insurers Association of America for 1985-1986, there were a total of 331 closed claims for wrong-site surgery.³ The Joint Commission on Accreditation of Healthcare Organizations initiated their review of sentinel events in 1997 (defined as an unexpected occurrence involving death or serious physical or

psychological injury, or the risk thereof), and found that wrong-site surgery is frequently one of the top ten most reported medical errors that cause patient injury.⁴ The JCAHO’s analysis found that it was most common among orthopedic surgeries, second most common among urological surgeries and third most common among neurosurgical procedures. There are no documented claims rates for ophthalmology, but anecdotal reports suggest that these errors also occur on a rare basis. Although this occurs on a rare basis, the consequences could be visually devastating, and thus, measures should be taken to eliminate the possibility of wrong-site surgery.

Contributing Factors to the Problem:

In 1998, the Joint Commission reviewed 15 cases related to wrong-site surgery.⁵ The three areas where failure occurred included communication with the patient and among members of the surgical team, preoperative assessment of the patient, and the procedures used to verify the operative site. In the area of communication failures, patients did not participate in identifying the surgical site in the informed consent process or in marking the surgical site. There was also failure in communication among the surgical team, either because some members of the team were not included in the process of verifying the site of surgery or because the surgeon was solely responsible, and other members felt that they couldn’t point out an error.

In the area of preoperative assessment, the common problem was the failure to review the medical record in the immediate preoperative period. Flaws in the procedures for verification of the operative site included the following:

lack of a formal procedure or protocol
lack of a final check while in the operating room
lack of oral communications
lack of medical record information or imaging studies in the operating room
lack of a checklist to assure that everything had been performed

Factors believed to contribute to increased risk of wrong-site surgery included:

involvement of more than one surgeon
performance of multiple procedures on the same patient
time pressures to complete the preoperative procedures more quickly
patient characteristics such as physical deformity or morbid obesity that might alter the usual set-up of equipment or positioning of patient

Ideas for Improving Patient Safety:

Wrong-site surgery is preventable with appropriate procedures for verification. Ideas for elimination of wrong-site surgery involve these common elements:

Commitment to development of a clear procedure to eliminate errors, albeit rare in occurrence
Availability of the patient’s relevant medical records in the operating room
Participation of the patient
Participation of the surgical team, not just the operating ophthalmologist
Marking of the operative eye
Documentation (or checklist) that criteria for verification of the operative site were met

The Joint Commission recommends the following strategies:

Clearly mark the operative site and involve the patient in the marking process to enhance the reliability of the process
Require an oral verification of the correct site in the operating room by each member of the surgical team
Develop a verification checklist that includes all documents referencing the intended operative procedure and site, including the medical record, X-rays and other imaging studies and their reports, the informed consent document, the operating room record, and the anesthesia record, and direct observation of the marked operative site on the patient.

The American Academy of Orthopaedic Surgeons (AAOS) and the American Association of Orthopaedic Surgeons recommends that the surgeon’s initials be placed on the operative site using a permanent marking pen and then the surgeon operate through or adjacent to the initials.⁶ The AAOS also recommends that the patient’s records be available in the operating facility.

University hospitals and ophthalmological departments have established formal procedures for marking and verification of operative sites for unilateral eye surgery. One example is at The Johns Hopkins University Wilmer Ophthalmological Institute.⁷ This procedure involves spelling out the operative eye (abbreviations are not acceptable) on the informed consent form, and matching the operative eye against the doctor’s orders for pre-operative medication or dilation, the patient’s ocular history and examination and patient response.

Prior to administration of treatment (i.e., dilation), the nurse asks the patient which eye is being operated and verifies the patient’s response on the operative site against the informed consent, physician’s orders and/or the ocular history and exam. For children or adults not competent to provide consent, verification of the operative eye is performed with the parent or responsible adult accompanying the patient. Prior to administering the anesthetic injection or sedation, the anesthesia staff/surgeon reviews the informed consent, orders and verifies the operative eye with the patient. The surgeon or assistant surgeon marks the skin adjacent to the operative eye with his/her initials (bilateral cases are exempt from marking, as are cases in which the decision to be operated upon is to be made during surgery after the patient has been sedated).

Prior to the incision, the surgeon reviews the informed consent, and ocular history and exam. Verification of the operative eye is documented by the nurse on the appropriate form. If there is any discrepancy at any point, the process is stopped. The attending surgeon must make the final determination and the discrepancy is then corrected prior to proceeding to the next procedure step. Even though the eye is marked, each step of the verification procedure is still followed through.

In cases of enucleation for intraocular tumor, the surgeon or assistant surgeon performs an additional verification of the operative eye by direct eye examination including a dilated fundus exam in the operating room, prior to surgery.

At a minimum, the following steps are suggested for ophthalmologists to minimize risks of wrong-site surgery, and to slow down and pay attention to the following:

asking the patient and surgical team prior to surgery
reviewing the ophthalmic history and exam in the operating room
marking next to the operative eye

If wrong-site surgery is being performed or has been performed, then the surgeon should act in the best interests of the patient, inform the patient and family, request their written consent, if they are not already sedated, to proceed to the correct site, and record this event in the medical chart. Discussion, actions and results should be documented in the patient’s medical record, and reported to the appropriate risk management staff and/or legal counsel, if appropriate.

SUGGESTIONS FOR A CHECKLIST TO VERIFY THE OPERATIVE EYE

PLEASE READ THIS DISCLAIMER:

These are suggested ideas for a checklist, however, they may not be appropriate, feasible or desirable in all settings and for all patients. This checklist should not be deemed inclusive of all proper methods to verify the operative eye, or exclusive of other protocols that are reasonable at obtaining the same results. The ultimate judgment regarding the utility and application of suggestions listed herein must be made by the operating surgeon (in collaboration with nursing and anesthesia staff) in light of all the circumstances presented by the patient, setting of care, and other factors.

The patient’s informed consent form describes the operative eye (e.g., right eye, left eye, abbreviations are not acceptable), and the patient understands which eye is being operated on and which procedure is being performed.

The ophthalmic history and exam are available in the operating room.

Prior to administration of eye drops or medication, the nurse asks the patient which eye is being operated on.

The patient’s response, the informed consent, the doctor’s orders for medication or dilation of the operative eye, and the ophthalmic history and exam all match for operative eye.

The surgeon/assistant surgeon marks the skin next to the operative eye with his/her initials.

Prior to administration of anesthetic injection or sedation, the anesthesia staff /surgeon verify the operative eye with the patient, informed consent and/or ophthalmic history and exam, and they all match.

Immediately prior to incision, the surgeon verifies the operative eye with the ophthalmic history and exam.

If there is any discrepancy among the patient’s response, the informed consent, the doctor’s orders, ophthalmic history and exam, the surgeon makes the final determination and the discrepancy is corrected before proceeding with the procedure.

Developed by the AAO Quality of Care Secretariat in collaboration with ASORN and AAEEH, March 2001

References:

Institute of Medicine: To Err is Human: Building a Safer Health System. National Academy Press, 1999, Washington DC.
National Patient Safety Foundation Research Agenda, 1999. Chicago Illinois.
American Academy of Orthopaedic Surgeons Report of the Task Force on Wrong-Site Surgery, September 1997, Revised February 1998
http://www.jcaho.org/sentinal/se_stats.html
Joint Commission on Accreditation of Healthcare Organizations: Sentinal Event Alert Issue Six, August 28, 1998.
Advisory Statement: Wrong-Site Surgery. American Academy of Orthopaedic Surgeons and American Association of Orthopaedic Surgeons, October 1997.
Verification and Marking of the Operative Eye, The Johns Hopkins Hospital Wilmer Ophthalmological Institute Interdisciplinary Clinical Practice Manual, revised August 2000.