A guide to TQM in LASIK

The flow-chart (fig.48) outlines a best practise pattern to the decision making path in LASIK surgery and summarises the thesis for the interested ophthalmologist. The numbers cited in the flow-chart refer to information discussed in the previous chapters.

Refractive surgeries seem to be a rather quickly learned compared to other surgeries in ophthalmology. However, due to the fact that it must compete with harmless prosthetic "competition" highest standards are essential. Where as in usual "non-elective" surgery fair results still may justify the operation, Refractive Surgery must never decrease best corrected visual outcome after surgery. Besides best surgery, a perfect presurgical selection is of upper importance to obtain that all patients who have undergone surgery do not regret their decision.

A Total Quality System for LASIK has been built in the last chapter. After true patient oriented quality characteristics had been discussed, the patients "individual input" was analysed. Then realistic quality indicators were defined. Knowing the goals, the processes and potential quality of the clinic were analysed and newly designed. The flow-chart (fig.48) outlines a best practise pattern to qualify highest standard LASIK surgery.

Of course, there are many ways of how and at what stage decisions should be taken. However, a preferred practise pattern will be essential for Total Quality Management. Moreover, it gives ophthalmologists a quick overview about LASIK surgery and it is a good orientation to start a structured discussion on LASIK procedures.

A best practise pattern in any medical procedure should fulfil various requirements. The goals which a best practise pattern in LASIK surgery has to fulfil are listed below in accordance to their priorities. Specific goals to be especially mentioned are written below their general goal.

1. to minimise potential risk,
• to select only "good candidates"
2. to ensure best possible outcome (effective),
• to ensure best patient integration
3. to be efficient
• to be as simple as possible
• to select all "good candidates" for surgery
4. to provoke continuos improvement process
5. to provoke further investigation and research
Figure 47: Requirements of a Best Practise Pattern
The process of presurgical selection has been designed to fulfil these goals. The decision making has been developed into three major steps (fig.48). In the first two steps the patient is checked to ensure the absence of any clinical contra-indications, thereby most obvious contra-indications come first. This advance ensures that presurgical selection is cost efficient and kind to the patient.

 
Even at the early stage of appointment making some contra-indications can already been checked. However, here the information must be obtained in a very informal way and the patient must never be frightened by mentioning specific contra-indications. Only in the case the patient does not fulfil the requirements, the contra-indication should be mentioned and explained. For instance, asking the patient on the phone, whether he has got two eyes, will certainly not improve the integration of the patient. Instead all relevant information can be obtained by asking for the reason for his last ophthalmologic consultation. Even telling all patients that they must be above 18 years can generated undesired questions. Only if the patient's voice suggests an age below 18 years, the question might be asked. At this early stage it does not really matter, if obvious contra-indications have not been checked completely, if otherwise the patient might be lost. In this very early phase it is most important to motivate the patient to be willing to undergo the complete selection phase. During the first part of his first consultation nearly all possible contra-indications will be checked against the facts and the first set of necessary data for surgery is obtained. During the second part of the consultation, complete measurements for the LASIK surgery are being taken. Last information about the existence of very seldom contra-indications is also obtained. The big corneal measurement exists of traditional keratography, modern topography and cycloplegic vision examination. Although the traditional keratography is not essential, it helps to improve to find the individual visual center at surgery. Moreover, it verifies and identifies the processed data of modern topography. Pictures of modern topography can easily be exchanged, where as pictures of traditional topography still show the complete eye of the patient. After the cycloplegic vision examination the retina needs to be fully checked to ensure that there is no sign for retinal surgery during the first three months after LASIK surgery, as this surgery requires a healed/clear cornea. This examination is particularly important in high myopic patients who have a much higher possibility to suffer from a sudden tear of retina. The sequence of the described examinations should not be changed as only few sequences allow to take all necessary examinations on the same day.

After all possible contra-indications have been checked against the facts and complete clinical data has been obtained the question whether the potential quality of the patient allows full ablation can be answered. If the questions turns out to be positive the patient should be asked for scheduling the surgery. If the potential quality of the patient is limited he should then be asked about his subjective priorities of vision in the fields where his vision might be limited after full laser correction. Then the surgical parameters can be matched with his personal priorities. However, only if the scheduled outcome can fully meet the individual expectation surgery is to be scheduled.

During the first year after the surgery the patient should undergo four controls to ensure the success of surgery and improve the quality standards of the institution. The complete process of Refractive Surgery should be controlled by computer-assisted information management. Statistical process control is essential to point out any imperfections as early as possible and to reach or even improve quality goals. For some patients training of vision will ensure successful adaptation of their improved but changed vision.