Patient Safety Advisory Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 2, No. 1 (March 2005) Produced by ECRI & ISMP under contract to the Pennsylvania Patient Safety Authority Focusing on Eye Surgery T wo distinct patterns emerge from a number of Serious Events and Incidents reported to PA- PSRS involving eye surgery: wrong side surgery and would still be visible after draping, which is an ele- ment of the guidance on site marking published by the Joint Commission on Accreditation of Healthcare problems with intraocular lens (IOL) implants. Organizations (JCAHO).1 Just beyond the eye’s me- dial or lateral angles might be a suitable alternative in While marking the surgical site has received much some cases. Another alternative could be to mark the attention as a promising safety practice, marking the eyelid of the operative eye, and to verify the presence eye—by virtue of its unique anatomy—may present a of the surgical mark on the right or left side when ap- problem for clinicians. Any mark placed near or plying lid clamps. The lid clamps could then be a around the eye may be obscured by surgical drapes proxy for the surgical mark. and may not be visible during a pre-procedure time out. The scrub nurse (who made the initial surgical mark) was not present during the operative site verification. Problems associated with intraocular lenses reported We can only conjecture whether the scrub nurse to PA-PSRS concern the implantation of a different might have caught this error had she been present, lens than the clinical team intended. IOLs may vary but a possible systems solution to this problem would by size, power and type. After reviewing case studies include having all team members present for a pre- of several reports, we discuss protocols that may help procedure time out. Another preventive measure to promote positive outcomes. might include making the surgeon responsible for making the surgical mark. The American Association Case Studies in Wrong-Side Procedures of Ophthalmologists (AAO) suggests that “the sur- Case #1—In this well documented report, a pa- geon/assistant surgeon marks the skin next to the tient undergoing surgery was asked to identify the operative eye with his/her initials.”2 JCAHO’s Univer- operative site, which the scrub nurse marked with sal Protocol, which has been endorsed by AAO and an “X” above the eye. A physician finished the the American Society of Ophthalmic Registered surgical prep and draped the site. Several mem- Nurses (ASORN), also specifies that the person per- bers of the surgical team verified the operative forming the procedure be responsible for site mark- site, and all sources of information were consis- ing.1 Yet, a June 2004 survey conducted by ASORN tent regarding the correct side for surgery. As the found that 58% of respondents from 216 sites re- procedure progressed team members believed ported that markings are being performed by RNs, they were operating on the correct eye. Intra- and only 22% reported that markings are being per- operative and postoperative documentation listed formed by physicians.3 the correct eye as having surgery. However, when the patient arrived in the PACU, the wrong Case #2—A patient having cataract surgery veri- eye was draining and surgically tender. fied the side for surgery with a nurse. The operat- ing room schedule, the permit, and the history Several elements of this case may have contributed and physical were in agreement with the patient. to this error. First, the use of an “X” as the surgical The nurse proceeded to mark the site for surgery mark is nonspecific. It could indicate the surgical site, but could easily be misinterpreted as a warning indi- cating the non-operative site. In a follow-up contact, This article is reprinted from the PA-PSRS Patient Safety Advisory, Vol. 2, No. 1—March 2005. The Advisory is a publication of the Pennsylvania Patient the Patient Safety Officer at this facility stated that Safety Authority, produced by ECRI & ISMP under contract to the Authority as their policy is to use the surgeon’s initials as the surgi- part of the Pennsylvania Patient Safety Reporting System (PA-PSRS). cal mark, consistent with guidance from other organi- zations.1 Copyright 2005 by the Patient Safety Authority. This publication may be re- printed and distributed without restriction, provided it is printed or distributed in its entirety and without alteration. Individual articles may be reprinted in their As stated previously, the surgical mark was obscured entirety and without alteration provided the source is clearly attributed. after the operative site was draped. The mark was To see other articles or issues of the Advisory, visit our web site at placed above the eye rather than in a location that www.psa.state.pa.us. Click on “Advisories” in the left-hand menu bar. ©2005 Pennsylvania Patient Safety Authority Page 1 Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 2, No. 1 (March 2005) Focusing on Eye Surgery (Continued) and dilated the eye. A physician administering a Patient Safety Advisory. Your ophthalmology local anesthetic placed the needle in the wrong The hallmarks of this staff and surgeons will eye. The nurse stopped the physician just before protocol are pre- the anesthetic was administered. Thereafter, the operative verification, want to know if your procedure proceeded correctly. marking the operative facility changes IOL site, and conducting a vendor. Variations in The report of this case does not mention a final time time out immediately the A-constant across out before beginning the procedure, and the surgical prior to beginning the different manufactur- mark may also have been obscured in this case. We procedure. The AAO has previously reported on the JCAHO Universal Protocol developed the following ers’ lenses may invali- for Preventing Wrong Site, Wrong Procedure, Wrong guidance, consistent date their calculations Person Surgery1 in the September 2004 PA-PSRS with the Universal Proto- for the correct diopter col: for the patient. Table 1. Suggestions for Minimizing Wrong IOL Implantation • Prior to administra- tion of anesthetic injection or sedation, the anes- 1. The ophthalmic history and exam and form that contains thesia staff/surgeon verifying the operative eye keratometry and axial length, primary and alternate lens/es with the patient, informed consent and/or the oph- for each patient are available in the operating room. thalmic history and exam, and confirming that 2. The surgeon/assistant surgeon selects the primary and alter- they all match. nate IOL/s before the start of the case. The surgeon verifies • Immediately prior to incision, the surgeon verify- the IOL number, diopter, optic, A constant, and length ing the operative eye with the ophthalmic history against the appropriate form or documentation and/or patient and exam. medical record. 3. When the surgeon requests the IOL, the circulating nurse • In the event of any discrepancy among the pa- shows the IOL box to the surgeon and verbally states the tient’s response, the informed consent, the doc- IOL model number and lens power and the surgeon ac- tor’s order, and the ophthalmic history and exam, knowledges the communication. the surgeon making the final determination and correcting the discrepancy before proceeding with 4. The circulating nurse then repeats this procedure with the the procedure. scrub nurse/technician (i.e., shows the IOL box and verbally states the model number and lens power). • Developing a checklist for verification that all 5. The scrub nurse/technician verbally states the model number documents are congruous and that all parties in- and lens power as he/she passes the lens to the surgeon for volved, including the patient, agree on the loca- implantation. tion of surgery.2 6. The surgeon performs visual inspection of the IOL under the In any complex environment, the potential always microscope for appropriateness and any lens defect or de- exists for human error. Patient safety protocols, such posit. as site marking and the time out, do not necessarily 7. If there is a discrepancy the surgeon reviews the ophthalmic reduce the rate of human error. Rather, they are history and exam and/or designated institute form. mechanisms by which we aim to make human error more observable and by which we build redundancy 8. The circulating nurse puts the IOL labels on the IOL card, into the system, hopefully mitigating the conse- operative record/patient chart right after the surgeon im- quences of errors by catching them before they reach plants the IOL. the patient. 9. Have good communications among the surgeon/assistant surgeon and operating room personnel, and check the lens Intraocular Lens (IOL) Problems power against the medical record in the operating room. PA-PSRS has received several reports in which the wrong intraocular lens was implanted in the patient’s 10. The correct lens should be in the operating room prior to eye. Half of the reports indicate that the patient re- sedation/anesthesia. turned to the OR for implantation of the correct lens. Source: American Association of Ophthalmologists. Reprinted In one case the patient was satisfied with the level of with permission. correction obtained even with the incorrect lens. One report refers to the physician’s selection of the incor- rect lens from a cart. Page 2 ©2005 Pennsylvania Patient Safety Authority Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 2, No. 1 (March 2005) Focusing on Eye Surgery (Continued) The magnitude of the problem is evident from a re- Universal protocol for preventing wrong site, wrong procedure, wrong person surgery [online]. 2003 Jul 18 [Cited 12 Nov 2004]. view of a decade of claims. The Ophthalmic Mutual Available from Internet: http://www.jcaho.org/ Insurance Company reviewed 168 claims which oc- accredited+organizations/patient+safety/universal+protocol/ curred from 1987 to 1997. Cataract procedures repre- wss_universal+protocol.htm. sented 33% of all closed claims during this period, 2. American Association of Ophthalmologists. Eliminating wrong and IOL cases were the largest group in the sample.4 site surgery, patient safety bulletin 1 [online]. [Cited 10 Nov 2004.] Causative factors identified with implanting the wrong Available from Internet: http://www.aao.org/education/library/safety/ site.cfm. IOL include: use of an outdated IOL formula for the 3. American Society of Ophthalmic Registered Nurses. ASORN patient, incorrect biometry or keratotomy readings, Quick Question #6, [online] June 2004. [Cited 10 Nov 2004.] Avail- mistakes in entering data into an IOL calculation pro- able from Internet: http://webeye.ophth.uiowa.edu/asorn/QQ/ gram, incorrect IOL labeling or packaging, and mis- QQ06.htm. takes in providing the IOL during surgery.5 4. Brick DC. Risk management lessons from a review of 168 cata- ract surgery claims. OMIC Publication Archives, Digest, [online]. Summer 1997, 1-9. [Cited 21 Feb 2005] Available from Internet: Different formulas can be used to determine the cor- http://www.omic.com/resources/risk_man/deskref/clinical/41.cfm. rect IOL, and each formula includes a variable known 5. American Association of Ophthalmologists. Minimizing wrong as a “lens constant.” A widely used formula uses the IOL placement, patient safety bulletin number 2 [online]. [Cited 10 “A-constant,” which is dependent on the specifics of Nov 2004.] Available from Internet: http://www.aao.org/aao/ the IOL design” and, as required by the FDA, is education/library/safety/iol.cfm. printed on the IOL packaging by the manufacturer.6,7 6. Schwiegerling J. Optics of intraocular lenses. Clinical Optics This A-constant is used in a string of interconnected [online]. [Cited 11 Mar 2005.] Available from Internet: http:// www.ophthalmic.hyperguides.com/tutorials/clinical/optics_lenses/ calculations to determine the best lens for each pa- tutorial.asp tient. A quick review of five companies’ products re- 7. Wallace B. Refractive cataract surgery. Clinical Optics [online]. vealed A-constants ranging from 114.2 to 119, with [Cited 11 Mar 2005.] Available from Internet: http:// different A-constants for the same lens diopter. www.ophthalmic.hyperguides.com/tutorials/cateracts/ refractive_cataract/tutorial.asp If your facility changes vendors or lens manufactur- 8. Gordon A. Telephone Conversation with: Monica Davis. 2005 March 4. ers, it would be helpful to notify all ophthalmologists so the calculations can be adjusted accordingly. Ide- ally, the surgeon would select the lens prior to enter- ing the operating room and note the change in ven- dor. However, this is often a delegated responsibility, and surgeons may unknowingly implant a different manufacturer’s lens, not recognizing that a formula change is necessary because of differences in the A- constant between different manufacturers’ products.8 Suggestions for IOL verification in the operating room advocated by the American Academy of Ophthalmol- ogy, the American Society of Ophthalmic Registered Nurses, and the American Association of Eye and Ear Hospitals are presented in Table 1.5 Notes 1. Joint Commission on Accreditation of Healthcare Organizations. ©2005 Pennsylvania Patient Safety Authority Page 3 Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 2, No. 1 (March 2005) An Independent Agency of the Commonwealth of Pennsylvania 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, as contractor for the PA-PSRS program, is issuing this newsletter 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 Authority’s website at www.psa.state.pa.us. ECRI is an independent, nonprofit health services research agency dedicated to improving the safety, efficacy and cost-effectiveness of healthcare. ECRI’s focus is healthcare technology, healthcare risk and quality management and healthcare environmental management. ECRI provides information services and technical assistance to more than 5,000 hospitals, healthcare organizations, ministries of health, government and planning agencies, and other organizations worldwide. 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 non-punitive approach and systems-based solutions. Page 4 ©2005 Pennsylvania Patient Safety Authority