Despite implementation of the Safe Surgical Checklist, a review of current literature and statistics from ASCs and hospitals across the country demonstrate wrong intraocular lens implants continue to happen. Further steps are needed to avoid these errors.
This is a common procedure performed in many ASCs. Multiple cases are usually performed back-to-back on the same day, in the same surgical suite, which increases the likelihood for errors. The correct lens is a specific calculation done before the patient arrives at the center. On the day of surgery, there is usually a cabinet full of lenses of several sizes and it is easy to grab the wrong box.
A study by Simon et al in 2007 analyzed both Ophthalmic Mutual Insurance Company data from a 1999 study and a New York State database of reports. These studies found that IOL implant errors were due to intraoperative errors including failure to check the lens specifications, a lack of procedure for verification of the correct lens, confusion of patient name or wrong chart, nursing staff change during surgery or damaged lens packaging.
After reviewing my company's policies and procedures and analyzing potential pitfalls, a threat was identified. There was no final verification the lens being opened on the sterile field matched the physician's order in the patient's chart. Errors that could result from this oversight would be included under the umbrella of "wrong site, wrong person and wrong procedure." These are surgical errors that are preventable and include implant choice or surgical confusion. In a preemptive move to avoid errors, Regent Surgical Health has changed our facilities' processes.
Regent centers are now implementing an additional step in the "Time Out" for IOL implant surgeries. We have expanded our policies and practices to include a very specific IOL Time Out that has been recommended by The American Academy of Ophthalmology. The centers are in the process of educating their staff and physicians and the expectation we have set is that this additional safety check will be completed for ,"Every IOL surgery, Every time, No exceptions, No Excuses." This is a Regent system-wide performance improvement project and the outcome data along with any near misses will be collected and shared among the centers (without patient or center identification) so we can all learn from each other.
There are literature and recommendations published by the AAO that specifically addresses this issue. Every center is unique so administration should work together with their surgeons to review their current practice and develop their own facility-specific policy and procedure. The following are helpful guidelines from the AAO for IOL verification:
American Academy of Ophthalmology Intraocular Lens Implant Guidelines 1
• The ophthalmic history and exam and form that contain keratometry and axial length, primary and alternate lens(es) for each patient are available in the operating room.
• If at all possible, there should only be one IOL measurement per eye on the form. If your computerized IOL measurement program allows, refrain from printing measurements for the left and right eyes on one form.
• The surgeon/assistant surgeon selects the primary and alternate IOLs before the start of the case. The surgeon verifies the IOL number, diopter, optic, A constant, and length against the IOL Calculation Report form or documentation and/or patient medical record.
• Before incision or when the surgeon requests the IOL, the circulating nurse shows the IOL box to the surgeon. The surgeon and circulating RN verify the IOL model, power and other calculation information, patient identification, and operative eye against the IOL Calculation Report as contained in the patient chart.
• The circulating nurse then repeats this procedure with the scrub nurse/technician (i.e. shows the IOL box and verbally states the model number and lens power).
• The scrub nurse/technician verbally states the model number and lens power as he/she passes the lens to the surgeon for implantation.
• The surgeon may elect to perform visual inspection of the IOL under the microscope for appropriateness and any lens defect or deposit.
• If there is a discrepancy, the surgeon reviews the IOL Calculation Report or ophthalmic history and exam and /or designated institute form.
• The circulating nurse puts the IOL labels on the IOL card, operative record/patient chart right after the surgeon implants the IOL. He or she documents the IOL verification procedure in the patient record.
Additional IOL implant processes Regent Surgical Health is having its centers focus on include:
1. The written order prior to day of surgery should include the surgical procedure, the operative eye, medications, and the IOL to be used.
2. If only one eye is to have surgery, the site must be marked by the surgeon before the patient enters the surgical suite. By placing a small dot on the outer aspect of the eye or cheek using a surgical marker, the team will be able to see the mark during the surgical prep and immediately before draping. I don’t recommend using tape to mark the correct eye as tape can fall off. Whatever process you use to mark the correct eye should be specific in the center's P&P and no exceptions should be made.
3. Time Out-The team along with the patient verify the proper eye is being prepped. All members of the surgical team actively participate in this. Any discrepancies or questions will result in a "Stop." It's important that the culture in the center enables the staff to speak up when they have a concern or question at any time.
4. Visual in the OR- Some form of written documentation available for the physician and the circulator that shows the patient’s name, the eye and the IOL power is visible in the OR. This can be written on the white board, an index card or a form.
Feel free to contact me for a copy of the Time Out form we're using at Regent Surgical Health centers or an example of an IOL-specific policy. We are all patient advocates and I am glad to share what I have learned over the years. I encourage all ASCs doing IOL implants to look at their current practice and consider adding an additional IOL verification "Time Out." Most ASC administrators likely assume this is part of the current time out, but the documented national data of wrong IOL implants shows this step is being missed.
Footnotes
1 American Academy of Ophthalmology, American Society of Ophthalmic Registered Nurses, American Association of Eye and Ear Hospitals. Minimizing wrong IOL placement: patient safety bulletin #2: 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. [cited 2008 January 28]; Available from: http://www.aao.org/education/statements/safety/iol.cfm
To contact Kathleen Bernicky, Director of Clinical Operations at Regent Surgical Health, please send emails to kbernicky@regentsurgicalhealth.com.
This is a common procedure performed in many ASCs. Multiple cases are usually performed back-to-back on the same day, in the same surgical suite, which increases the likelihood for errors. The correct lens is a specific calculation done before the patient arrives at the center. On the day of surgery, there is usually a cabinet full of lenses of several sizes and it is easy to grab the wrong box.
A study by Simon et al in 2007 analyzed both Ophthalmic Mutual Insurance Company data from a 1999 study and a New York State database of reports. These studies found that IOL implant errors were due to intraoperative errors including failure to check the lens specifications, a lack of procedure for verification of the correct lens, confusion of patient name or wrong chart, nursing staff change during surgery or damaged lens packaging.
After reviewing my company's policies and procedures and analyzing potential pitfalls, a threat was identified. There was no final verification the lens being opened on the sterile field matched the physician's order in the patient's chart. Errors that could result from this oversight would be included under the umbrella of "wrong site, wrong person and wrong procedure." These are surgical errors that are preventable and include implant choice or surgical confusion. In a preemptive move to avoid errors, Regent Surgical Health has changed our facilities' processes.
Regent centers are now implementing an additional step in the "Time Out" for IOL implant surgeries. We have expanded our policies and practices to include a very specific IOL Time Out that has been recommended by The American Academy of Ophthalmology. The centers are in the process of educating their staff and physicians and the expectation we have set is that this additional safety check will be completed for ,"Every IOL surgery, Every time, No exceptions, No Excuses." This is a Regent system-wide performance improvement project and the outcome data along with any near misses will be collected and shared among the centers (without patient or center identification) so we can all learn from each other.
There are literature and recommendations published by the AAO that specifically addresses this issue. Every center is unique so administration should work together with their surgeons to review their current practice and develop their own facility-specific policy and procedure. The following are helpful guidelines from the AAO for IOL verification:
American Academy of Ophthalmology Intraocular Lens Implant Guidelines 1
• The ophthalmic history and exam and form that contain keratometry and axial length, primary and alternate lens(es) for each patient are available in the operating room.
• If at all possible, there should only be one IOL measurement per eye on the form. If your computerized IOL measurement program allows, refrain from printing measurements for the left and right eyes on one form.
• The surgeon/assistant surgeon selects the primary and alternate IOLs before the start of the case. The surgeon verifies the IOL number, diopter, optic, A constant, and length against the IOL Calculation Report form or documentation and/or patient medical record.
• Before incision or when the surgeon requests the IOL, the circulating nurse shows the IOL box to the surgeon. The surgeon and circulating RN verify the IOL model, power and other calculation information, patient identification, and operative eye against the IOL Calculation Report as contained in the patient chart.
• The circulating nurse then repeats this procedure with the scrub nurse/technician (i.e. shows the IOL box and verbally states the model number and lens power).
• The scrub nurse/technician verbally states the model number and lens power as he/she passes the lens to the surgeon for implantation.
• The surgeon may elect to perform visual inspection of the IOL under the microscope for appropriateness and any lens defect or deposit.
• If there is a discrepancy, the surgeon reviews the IOL Calculation Report or ophthalmic history and exam and /or designated institute form.
• The circulating nurse puts the IOL labels on the IOL card, operative record/patient chart right after the surgeon implants the IOL. He or she documents the IOL verification procedure in the patient record.
Additional IOL implant processes Regent Surgical Health is having its centers focus on include:
1. The written order prior to day of surgery should include the surgical procedure, the operative eye, medications, and the IOL to be used.
2. If only one eye is to have surgery, the site must be marked by the surgeon before the patient enters the surgical suite. By placing a small dot on the outer aspect of the eye or cheek using a surgical marker, the team will be able to see the mark during the surgical prep and immediately before draping. I don’t recommend using tape to mark the correct eye as tape can fall off. Whatever process you use to mark the correct eye should be specific in the center's P&P and no exceptions should be made.
3. Time Out-The team along with the patient verify the proper eye is being prepped. All members of the surgical team actively participate in this. Any discrepancies or questions will result in a "Stop." It's important that the culture in the center enables the staff to speak up when they have a concern or question at any time.
4. Visual in the OR- Some form of written documentation available for the physician and the circulator that shows the patient’s name, the eye and the IOL power is visible in the OR. This can be written on the white board, an index card or a form.
Feel free to contact me for a copy of the Time Out form we're using at Regent Surgical Health centers or an example of an IOL-specific policy. We are all patient advocates and I am glad to share what I have learned over the years. I encourage all ASCs doing IOL implants to look at their current practice and consider adding an additional IOL verification "Time Out." Most ASC administrators likely assume this is part of the current time out, but the documented national data of wrong IOL implants shows this step is being missed.
Footnotes
1 American Academy of Ophthalmology, American Society of Ophthalmic Registered Nurses, American Association of Eye and Ear Hospitals. Minimizing wrong IOL placement: patient safety bulletin #2: 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. [cited 2008 January 28]; Available from: http://www.aao.org/education/statements/safety/iol.cfm
To contact Kathleen Bernicky, Director of Clinical Operations at Regent Surgical Health, please send emails to kbernicky@regentsurgicalhealth.com.
