Pennsylvania Patient Safety Advisory Still Not Seeing Clearly—A Second Look at Intraocular Lens Implant Events In the March 2005 issue of the Patient Safety Advisory, Figure. PA-PSRS Wrong Intraocular Lens Implant an article reviewed the Serious Events and Incidents Reports by Quarter reported through PA-PSRS regarding eye surgery. NUMBER Two distinct patterns were identified at that time: OF REPORTS (1) wrong-side surgery and (2) incorrect intraocular 10 lens (IOL) implants.1 This follow-up article looks at the frequency of incorrect IOL placement events since the inception of PA-PSRS to discuss the identified process 8 7 issues that may have contributed to the surgical error and the risk reduction strategies that are being imple- 6 mented to reduce the incidence of further events. 5 5 Since PA-PSRS began in June 2004 through Decem- 4 4 4 4 4 4 ber 2007, 48 cases involving implantation of the 3 wrong IOL have been reported. The number of these events has remained on average about 10% of all lens- 2 2 2 2 related events per year. In 32 of these events, patients 1 1 required a second procedure to implant the correct 0 IOL. Four of the patients did not require surgical Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 intervention, and reports of the remaining 12 cases 2004 2005 2006 2007 did not include this information (see Figure). REPORTS BY QUARTER Lessons Learned Cataract surgery patients, in most instances, are 5. OR staff members used information from the scheduled back-to-back. The patients are quite similar. wrong patient’s medical record. If staff skip steps in the verification of the IOL, surgi- 6. More than one lens was available in the OR. cal errors can result.2,3 7. The sequence of the scheduled patients was The doctor pulled the patient’s office chart and changed without corresponding changes to their the lens he would be using for the case. The doctor respective verification processes. checked the lens with the office chart. A 23.0 diopter lens was inserted. Postoperatively, the doctor realized Changes Going Forward he had pulled the wrong patient’s chart. The patient was to receive an 18.0 diopter lens. Additional sur- Events that result in implanting the wrong IOL can gery was necessary to remove the incorrect lens and be reduced by following strict policies of checking and implant the correct one. double-checking that the correct IOL is being used.4 The Joint Commission requires that the time-out per- Two patients were scheduled for cataract surgery. It formed immediately before starting the procedure will was decided to do the second patient first. The time-out include confirmation that the correct implant is ready was proper, and the proper patient, site, and surgery for use.5 The American Association of Ophthalmolo- were done. However, the lens implant for the first gists (AAO) has made suggestions to reduce instances patient scheduled was implanted in the second patient. of wrong IOL implants consistent with the guidance In the reports, the facilities identified several issues provided by the Joint Commission’s Universal Proto- that led to implanting the wrong IOL. The event data col for Preventing Wrong Site, Wrong Procedure and shows that the verification process is central in the Wrong Person Surgery™.6 These suggestions focus on majority of the reports. Issues identified included the the importance for the surgeon and OR personnel following: to develop good and consistent communication pro- cesses surrounding the verification of the IOL before 1. The physician or his or her office staff gave infor- implantation.1 AAO’s suggestions were reprinted mation from the wrong patient’s office chart in the aforementioned March 2005 Advisory article regarding the lens to be used. (http://www.psa.state.pa.us/psa/lib/psa/advisories/ 2. The surgeon/resident/other team members were v2n1march2005/vol_2-1-march-05-article_f-eye_ inattentive during the time-out. surgery.pdf). 3. The surgeon’s office record was not available in After implanting the wrong IOL, one Pennsylvania the operating room (OR) to review during the facility took specific steps to reduce the risk of this time-out. error recurring. The facility conducted a root-cause analysis that showed that the staff had multiple 4. The nurse picked up the wrong lens. inconsistent processes for verifying the IOL before Page 106 REPRINTED ARTICLE - ©2008 Pennsylvania Patient Safety Authority Vol. 5, No. 3—September 2008 Pennsylvania Patient Safety Advisory implantation. The facility standardized on a single may assist healthcare facilities in evaluating processes process with which all staff was to comply. The facility and preventing adverse events. Reducing the inci- has found that implementing and following a consis- dence of wrong IOL implantation is a team effort. tent process has been effective in reducing the risk of The importance of developing a verification process implanting the wrong IOL. The implemented process within a facility that is followed by the entire surgical is as follows: team is crucial in reducing these surgical errors. ■ The surgeon sends the office chart, which includes Notes the A-scan, to the OR before the surgery. 1. Pennsylvania Patient Safety Reporting System. Focus- ■ During the preoperative visit on the day of surgery, ing on eye surgery. PA PSRS Patient Saf Advis 2005 Mar; the circulating nurse verifies that the A-scan is 3(1):12-4. in the record and is the correct scan for patient 2. Ronge LJ. Human error during cataract surgery: right undergoing the procedure. patient, wrong lens. EyeNet Magazine [online]. 2006 ■ Immediately before the surgery, the surgeon visits Mar [cited 2008 Jan 17]. Available from Internet: http:// the patient, reviews the A-scan, selects the lens, www.aao.org/aao/publications/eyenet/200603/ and hands the lens to the circulating nurse. Pre- index.cfm. selection of the lens has been eliminated because 3. Jin GJ, Crandall AS, Jones JJ. Intraocular lens exchange a change in schedule may lead to the wrong lens due to incorrect lens power. Ophthalmology 2007 Mar; being set up for the wrong patient. 114(3):417-24. ■ Once in the room, the time-out is performed with 4. Laber D. Intraocular lenses: incorrect power calculations the entire OR team. The patient, procedure, site, analyzed. EyeWorld [magazine online]. 2006 Aug [cited and lens are verified by the surgeon and the scrub 2008 Jan 17]. Available from Internet: http://www. nurse. The staff has the patient’s office chart, surgi- eyeworld.org/article.php?sid=3310. cal medical record, lens, and lens box available to 5. Joint Commission. Implementation expectations review during the time-out. for the universal protocol for Preventing Wrong Site, ■ The circulating nurse and surgeon double-check Wrong Procedure And Wrong Person Surgery™ the IOL power together before beginning the [online]. 2003 [cited 2008 Jan 17]. Available from Inter- surgery. net: http://www.jointcommission.org/NR/rdonlyres/ DEC4A816-ED52-4C04-AF8C-FEBA74A732EA/0/ Other healthcare facilities in Pennsylvania include the up_guidelines.pdf. following steps in their verification process: 6. American Academy of Ophthalmology, American 1. Only the current surgical patient’s medical record Society of Ophthalmic Registered Nurses, American will be in the OR. Association of Eye and Ear Hospitals. Patient Safety Bul- 2. Only the current patient’s IOL will be in the letin. Minimizing wrong IOL placement [online]. 2005 room at the time of surgery. [cited 2008 Apr 4]. Available from Internet: http:// one.aao.org/CE/PracticeGuidelines/Patient_Content. 3. The time-out process will include the medical aspx?cid=38305f4c-4cb4-406a-953f-fc193cf2ade3. record from the physician’s office, with lens model and diopter clearly documented. 4. The surgeon will select and pull the lens and Reviewer Commentary: place it on the patient’s medical record before the At Wills Eye Hospital and also our ambulatory surgery center, we procedure and announce it to the nurse when have the doctors fill out a preferred lens form for each patient. The handing it into the sterile field. form is then faxed to the facility prior to surgery. The lens is selected by the nurse in the operating room. The lens is then verified the day Conclusion of surgery with the nurse and the doctor, and the doctor signs off that the correct lens has been picked and inserted. The IOL verification process begins in the physician’s office and ends with the correct lens being implanted. Michael L. Kay, MD The information gathered from these PA-PSRS events Wills Eye Hospital Vol. 5, No. 3—September 2008 REPRINTED ARTICLE - ©2008 Pennsylvania Patient Safety Authority Page 107 PENNSYLVANIA PATIENT SAFETY ADVISORY This article is reprinted from the Pennsylvania Patient Safety Advisory, Vol. 5, No. 3—September 2008. The Advisory is a publication of the Pennsylvania Patient Safety Authority, produced by ECRI Institute and ISMP under contract to the Authority as part of the Pennsylvania Patient Safety Reporting System (PA-PSRS). Copyright 2008 by the Pennsylvania Patient Safety Authority. This publication may be reprinted and distributed without restriction, provided it is printed or distributed in its entirety and without alteration. Individual articles may be reprinted in their entirety and without alteration provided the source is clearly attributed. This publication is disseminated via e-mail. To subscribe, go to https://www.papsrs.state.pa.us/ Workflow/MailingListAddition.aspx. To see other articles or issues of the Advisory, visit our Web site at http://www.psa.state.pa.us. Click on “Advisories” in the left-hand menu bar. THE PENNSYLVANIA PATIENT SAFETY AUTHORITY AND ITS CONTRACTORS The Patient Safety Authority is an independent state agency created by Act 13 of 2002, the Medical Care Availability and Reduction of Error (“Mcare”) Act. Consistent with Act 13, ECRI Institute, as contractor for the PA-PSRS program, is issuing this publication to advise medical facilities of immediate changes that can be instituted to reduce Serious Events and Incidents. For more information about the PA-PSRS program or the Patient Safety Authority, see the An Independent Agency of the Commonwealth of Pennsylvania Authority’s Web site at www.psa.state.pa.us. ECRI Institute, a nonprofit organization, dedicates itself to bringing the discipline of applied scientific research in healthcare to uncover the best approaches to improving patient care. As pioneers in this science for nearly 40 years, ECRI Institute marries experience and independence with the objectivity of evidence-based research. More than 5,000 healthcare organizations worldwide rely on ECRI Institute’s expertise in patient safety improvement, risk and quality management, and healthcare processes, devices, procedures and drug technology. The Institute for Safe Medication Practices (ISMP) is an independent, nonprofit organization dedicated solely to medication error prevention and safe medication use. ISMP provides recommendations for the safe use of medications to the healthcare community including healthcare professionals, government agencies, accrediting organizations, and consumers. ISMP’s efforts are built on a nonpunitive approach and systems-based solutions.