Ophthalmic surgeons who do LASIK surgery are now frequently choosing to do the procedure on both eyes at the same time. This approach has apparently evolved to suit both patient and practice convenience. Simultaneous, bilateral procedures are not without risk, however, and the practitioner should proceed with patient safety and risk management in mind.

Minimizing error, complications, and liability rest on three fundamental issues: good informed consent, good pre-operative assessment of the patient, and appropriate equipment management.

Informed Consent

As a fully developed process, informed consent involves:

·         patient education about the proposed procedure

·         discussions with the patient to ascertain their understanding of the information, answering any questions they may have, and determining whether they agree to the proposed surgery

·         signing and witnessing of a clearly worded, comprehensive consent form

·         documentation in the patient’s record that this process took place

The presence of a signed consent form in the record is not, by itself, sufficient documentation. There should be a remark in the progress notes memorializing patient education, discussion, and any specifics which are important to that patient or to that procedure.

No physician wishes to scare their patient pre-operatively with dire news of possible serious complications during surgery or post-op, but patients who sue because of those same intra- or post-operative difficulties invariably say they were not aware that the complication could happen. It is not appropriate to minimize known risks and complications for the sake of patient ease of mind; and it is wise to document that you had a preoperative discussion of potential complications. Patients may not remember that conversation clearly when complications occur, making your note very important if a suit is filed. As an example: an ophthalmologist verbally advised a LASIK patient pre-operatively of potential risks; this information was not documented in the chart with any specificity. The patient suffered serious complications and significant vision loss. Postoperatively this patient only remembered the physician mentioning the possibility of dry eyes or the need for reading glasses.

When approaching consent for bilateral simultaneous LASIK, it is important that the patient understand they have an option to have their surgery on each eye in separate procedures (allowing time in between procedures for the first eye to heal).  They should not get the impression through marketing materials, educational resources, the pre-operative discussion, or the wording of the consent form that bilateral simultaneous procedures are the only way this surgery is done.

The consent process must include a review of the material risks of the procedure and clearly state that the risks could affect both eyes. It also should explain the risks and benefits of LASIK done on one eye at a time and the documentation reflect whether the patient chooses or does not choose this approach. Both the chart note and the consent form itself should document that the patient was fully informed of these options. The consent form should have a place for the patient to indicate whether they choose individual surgeries or a bilateral simultaneous procedure. There should be a place for them to initial their choice along with their signature on the full form.

Download a sample consent form here.

Pre-Operative Assessment of the Patient
A substantial number of post-operative complications of bilateral simultaneous LASIK surgery involved alleged inadequate pre-operative assessment, especially in taking and documenting crucial eye measurements. Whether measurement was done, the means used, and the care with which the determination was made were called into question during subsequent suits. To prevent surgical error and liability, the pre-operative assessment process used in each practice must include:

• a routine process for taking measurements,  done on every potential pre-operative LASIK patient
• routine documentation of the measurements done on every patient considering LASIK
• careful explanations of the measurement process for the patient, answers to their questions, and documentation of this discussion

Equipment Management
Early LASIK equipment-related cases often involved the use of microkeratome blades. As these blades are being replaced by lasers, they figure less prominently in LASIK suits. But improvements in technology do not guarantee a reduction in claims.

Cases resulted from interruptions in routine protocols. For example, a patient arrived early and asked to be moved ahead on the surgical schedule. The practice was able to accommodate this request, the move was made, and involved staff members were notified. However, the technician from the laser company who was setting up the machine failed to confirm patient ID, and planned surgical information as was required; information for the patient who was supposed to be there at that time, rather than the patient who had been moved up, was programmed into the machine.

In this, as in the majority of equipment-related cases, human error caused the complication. It is imperative that careful protocols be established, that those protocols be followed every time the procedure is done, and that there is documentation to substantiate adherence to protocol.

It is also imperative that practitioners be very familiar with the equipment before they use it with patients. Injuries from mishandled equipment occur as the result of inappropriate machine settings and simple misuse of a device.

Summary
Simultaneous bilateral LASIK procedures are now done with increasing frequency. Just because they are common, however, does not diminish their risk.

Patients must be informed that they have the right to have one eye done at a time. They must understand the risks and benefits of this approach as well as the risks and benefits of bilateral simultaneous LASIK. It is important that they understand that, in bilateral procedures, complications usually occur in both eyes.

To minimize error and liability, the physician and practice must have routine protocols which are followed every time and documented every time. This approach includes informed consent, pre-operative assessments, and equipment management.

With this approach, the physician and practice can exhibit good patient safety and risk management.