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The basic idea of this work is to apply quality philosophies, proven successful in industry, to the medical service sector. Somehow, it seems surprising, how serious quality in car production is being taken, compared to quality aspects in surgery on human kind.
Refractive corneal surgery is a fairly young speciality of ophthalmology trying to eliminate the dependence on prostetic devices by surgery. In most cases the surgery is a selective choice by the patient, not to wear glasses or contact lenses in daily life. In some cases refractive corneal sur-gery can even improve best corrected vision.
Refractive corneal surgery might be the entrance door for wide application of Total Quality Man-agement (TQM) in medicine. In the majority of surgical procedures there exists no competition with non surgical alternatives and the urge for the survivial of a specific technique does not de-pend on quality control. There, the unspoken mentality is formed by the fact that the patient can only gain by the treatment. The job to obtain the ethical goal, securing best possible treatment in each patient, is not done.
However, the selective nature of refractive corneal surgery, standing in competition with success-ful prosthetic correction, makes quality aspects of major importance. In other words, if for any reason the surgery fails, the client has a lot to lose: quality of vision. This fact will help make surgeons open minded in applying overall quality control right from the beginning. For instance, open video control.
Refractive corneal surgery is an ambulant procedure and therefore by itself very patient friendly and cheap; no secondary costs for long accommodation are produced as the patient quickly re-covers in his home environment.
There are two long term ingredients for excellent refractive corneal surgery: scientific perfection and surgery's know-how, both of which must be reflected in the applied equipment and the surgi-cal process. The author selected the Barraquer clinic in Bogota as the study environment, as this clinic has the world's most profound and long term experience in refractive corneal surgery.
The application of Total Quality Management is in part process control. Generally the transfor-mation of prototype techniques into large scale production reveals unexpected difficulties. The major task of TQM is the improvement of the production process, not a scientific investigation of built theories. TQM at a high level requires experience with many and different patients to take into account unexpected difficulties. Patient numbers of a refactive surgeon in a typical European country range from zero to a hundred, only one technique is used, this will not allow the same potential, as the thirty year Barraquer experience with arround 15 000 cases covering nearly all refractive techniques on very different patients coming from all over the world.
The following chapter starts with an introduction into refractive corneal surgery. Experts in Re-fractive Surgery might not need to read this chapter, but for the unfamiliar reader, it will give new vocabulary and hopefully a "feeling" for what Refractive Surgery is about. It will be struc-tured but simple rather indepth, giving a short history and explaining the basic approaches and ideas of correcting vision. A comparison of the surgery outcome with system control will give a first set of criteria for evaluation of these techniques in practice. A systematic classification of refractive surgical techniques will give an overview of the roots which can be taken. Even for readers familiar with Refractive Surgery the classifcation will be interesting, as the techniques are classified by their intention of change, instead of similarities in surgery. Laser insitu keratomil-eusis will be explained from various points of view. The first chapter ends with an outlook of potential market size giving an idea of the possible impact in the near future. The US and Ger-man markets for refractive corneal surgery will analysed briefly.
The third chapter explains the basic ideas of quality philosophies coming from industry. The dif-ferent quality definitions even from various countries are discussed. Then tasks of Total Quality Management in the medical service sector and in refractive corneal surgery are analysed. Typical challenges of quality management are pointed out. Instruments and tools proofed successfully in industry are briefly introduced to win the battle of introducing Total Quality Management in the medical service sector.
The fourth chapter deals with the specific nature of services. Different service-oriented quality models are discussed. A pragmatic development of the common Model of Donabedian into the Model of Meyer is outlined. It is the change from rigid structure quality to potential quality of the institution. Even more, the potential quality of the patient is added. Both potential qualities come together to perform a unique process quality which will determine the final quality of the patient. The principal types of organising any production process are introduced each form is then dis-cussed for organising a service.
The fifth chapter builds a practical procedure of how to apply TQM in Refractive Surgery. Straight goals are set. The type of quality model is selected and criteria's for the quality indica-tors are defined.
Chapter six is the realisation of the total quality approach in LASIK surgery. It starts off with the discussion of true quality characteristics in LASIK surgery, asking for the wishes of the patients first. After the motivation of the patients and their complaints are analysed, functions and re-quirements about Refractive Surgery are derived and systematically defined. Then the structure follows strictly the selected Model of quality for medical services:
• the potential quality of the patient is analysed, in particular the eye profiles in regard to the LASIK surgery. The typical bottlenecks in the anatomy of the eye are worked out for myopic and hyperopic patients.
• the outcome quality is defined and an individual matchment scheme about individual priorities is developed. Clinical quality indicators and subjective patient quality indicators are defined to be able to measure the outcome with standard means.
• now knowing the goals, the whole process of service is analysed and newly designed to ensure that potential quality becomes outcome quality.
• now even more knowing the whole process the patient has to go through, it is much easier looking out for the real potential qualities of a clinic doing LASIK surgery: focus is the "bot-tleneck" equipment which determines today's quality of outcome and the management of staff. The experience of the surgeon is discussed in detail. A training scheme for future LASIK sur-geons is developed.
The seventh chapter presents a flow chart about the steps and the decision making in LASIK sur-gery. It somewhat gives a round up of the thesis for the ophthalmologist interested to perform LASIK surgery. The flow chart is taking advantage of the long Barraquer experience and of Total Quality Management. The thesis will end with a brief outlook.
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