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5. Building a Procedure for TQM in LASIK

This 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 indicators are defined.

5.1 Terminology

In respect to time and function, quality management can be divided into three fields. Quality planning, quality control1 and quality assurance.2 For direct industry purposes there even exist more detailed definitions, guiding the necessary actions to achieve standardised quality management. However, many of these specific quality procedures only apply to industrial production and make no sense in medical care. In this thesis we will develop our own procedure model for introducing quality management in Refractive Corneal Surgery. The main intention will be to find the best process from the first contact with the patient until his last check up after surgery.

For better understanding the mentioned quality terms will be explained in brief in accordance to German quality standards
[DIN87p.5, Dan93p.47].

Quality planning:
This is the selection, classification, and weighting of the quality characteristics and their indicators. Quality planning lays down the allowed limits in respect to what is recognised to be OK.

Quality control:
The operational techniques and activities that are used to fulfil requirements for quality. In practice quality control is the construction of a quality system which allows the given quality goals in quality planning to be reached. Further more, it is the continual questioning and improvement of the quality system.

Quality assurance (inspection):
All those planned and systematic actions necessary to provide adequate confidence that a product or service will satisfy the given requirements for quality.

This chapter will be part of quality planning. To be more accurate, it will be one step before setting the quality indicators. It will develop the adequate perspective, guiding the path of quality application, in order to be aware of what will be really important. Avoiding that quality management becomes an end in itself.

5.2 Goals of TQM in Refractive Corneal Surgery

Until recently, Refractive Corneal Surgery has been greatly limited by the technology available. All the used procedures have had their limitations. Refractive Surgery has been innovated by technology pushes. Patients, have seldomly been asked what they really wanted when undertaking Refractive Surgery. It seems that they have just been happy to be one of the few, who could afford to take advantage of Refractive Surgery, typically for technology pushed services.

Quality characteristics in Refractive Surgery have been a 'good deal of guesswork' of ophthalmologic authorities and been limited through used technology in measuring it. For instance, the Snellen test3 gives an idea of what individual vision is about. However, it can not be the only reference when applying a selective surgery on the eye, even when best correction can be reached with prosthetic devices. What happens with night vision after surgery, which is not measured with the Snellen test? Will it be the same?

With the introduction of laser technology, Refractive Corneal Surgery has become much easier to handle than with the former technologies. The direct surgical risks are lowered, so that from that point of view Refractive Surgery can easily become a normal public surgery. However, applying this surgery on a macroeconomic scale, it must not only be driven by a technology pushed attitude or applied without taking all the individual needs and circumstances into account. Even more, traditional substitute characteristics must be questioned and checked against the facts.

True quality characteristics should be studied. In accordance to Ishikawa, in the beginning of building a quality system, quality characteristics of vision must be expressed in the words of the patient, not in the language of physicians or in technical terms. Quality analyses quality deployment! Knowing the real wishes of the patient when asking for Refractive Surgery helps avoiding surprises after the surgery.

Moreover, the parameters of the surgery can be set into account to his individual situation, his typical working conditions etc. Of course, expressed patient wishes must also be expressed by clinical quality indicators. In the case of Refractive Surgery the author suggests a double strategy: building a set of pure subjective patient satisfaction indicators and a set of derived objective clinical quality indicators.

Satisfaction indicators
The satisfaction indicators will serve on two fields. Firstly, getting the surgery in best accordance to the wishes and expectations of the patient. Moreover, by including the patient in the decision making, motivation will increase and the potential quality of the patient will grow. Adequate application and best distribution of the surgery in respect to patients' wishes will help to satisfy more patients. Secondly, the satisfaction indicators will serve the long range perspective. They will lead the path into the future of Refractive Surgery, serving as a control function to the clinical quality indicators and indicating further needs for technological progress.

However, it must be guaranteed that the satisfaction indicators are defined completely independently of the (actual) technology standards, demonstrating that the true quality goals are free of technical stuck thinking, allowing an easy change to other technologies in the future.

Clinical quality indicators
And what is the second set, the clinical quality indicators, still good for? Well, only measuring the satisfaction of the patients will bear many disadvantages maintaining and improving the quality. The satisfaction of undemanding patients will always tend to be higher than of extremely demanding patients. Comparing solely happiness indices could lead to the belief, that in countries with low demanding patients the overall quality is higher, although in fact it is only a reflection of cultural differences. The logical consequence would be that demanding patients lower the quality.

In fact the opposite is the case, only high demanding patients force further improvement. The clinical quality indicators have many important functions which can not be achieved by the satisfaction indicators: comparability of results, comparability of surgeons' skills, self control of the surgeon , motivation to the surgeons to lower variety in results, and allow statistical quality control.

Once the clinical quality indicators which best reflect the patient's needs are set, their quality can be quantified in four levels: quality target, quality standard, inspection criterion, assured quality level; illustrated in the third part of the picture. The goal of statistical quality control is to lower the 'distance' between the target and the assured quality level. Similar are the already mentioned terms: quality of conformance and the quality of design. As quality of conformance is raised closer to the quality of design, cost will usually come down, and as complaints decrease, reputation will grow. In medicine, they often speak of the ABNA principle. It stands for achievable but not achieved benefits, illustrating the same situation. Comparing the three approaches shows that the ABNA principle is most rudimentary, somewhat revealing the level of quality care in medical care.

The goal of Total Quality Management in Refractive Corneal Surgery will be to meet the expectations of each patient, and to gradually lower the distance between the quality standard and the quality target to offer the highest possible vision satisfaction. Total Quality Management may even improve achievable quality by revealing unsolved problems, however it should not be confused with scientific investigation. Total Quality Management in Refractive Surgery means that everybody who has been operated on will achieve best possible results with the best adjustment to his personal situation.

5.3 Selecting the Quality Model

Applying Total Quality Management to a special case in ambulant medical care, one has to take into account the nature of the service to be successful. In Chapter four the nature of service was thoroughly discussed in respect to quality, and three models of service have been explained. Originally only the Model of Donabedian was designed for the medical service sector. The advantage of this model is that it is kept most simple. However, the Model of Donabedian seems rather misleading and uncompleted. Improving the structure is not a quality in itself, easily misleading to inefficient resource investment. The influence of the patient on the quality is not represented in the model at all. Grönroos is aware of the individual perception of each customer in his model, including the effect of the image on the judgement of a given service. Nevertheless, he also does not include the patient in the process, but only as a passive observing object. For our focus on process analysis the image has been overemphasised in this model, too.

The Model of Meyer seems most adequate in respect to applying Total Quality Management to Refractive Surgery. The potential quality of the patient in this surgery is of great importance. Firstly, each patient has got his individual refractive error, this error and the overall condition of his eye determine the achievable quality of his vision after surgery. Secondly, besides the diagnostic results, the patient is actively influencing the results during surgery. The surgery is ambulant and at one stage, the patient must centre his eyes, looking into an infra-red laser light. Depending on his co-operation, the result will be perfect or fair. Another advantage of the Model of Meyer is the upward compatibility with the Model of Donabedian commonly applied in medical care.

5.4 Criteria's for Quality Indicators

Quality indicators can easily become an inefficient end in itself, if they are not built systematically. Criteria's help to select only the relevant indicators.
5.4.1 Keep It Simple and Stupid (KISS)

Implementing any new process, changing the perspective, and changing culture will cause prepossession and opponents. Final acceptance will depend on whether, the new replacement makes things easier. The period of transition must be kept as short as possible. The new goals and their tools must be clearly defined and kept as simple as possible. Selecting a huge amount of quality indicators might be very successful in theory but in practice the project will most likely get stuck of work overload. When selecting quality indicators first principle will be to select as few as possible but as many as necessary to get the best practical success.

5.4.2 Known Influence to Outcome

The clinical (substitute!) quality indicators should not only represent the true patient quality characteristics in respect to the actual technique, but also be able to be improved in the future. For instance, if good night vision is a true patient's quality characteristic, there will be various clinical substitute quality indicators. Good night vision affected by the diameter of the optical zone treated, therefore the diameter will be a good clinical substitute for good night vision. Centration of the optical zone will also strongly influence the excellence of night vision and could represent a second clinical quality indicator in respect to good night vision.

5.5 Precision and the Risk of Faults

Once the clinical quality indicators have been selected, the aim of TQM will be to reduce the risk of faults to its theoretical minimum and to increase the precision of each output variable to its maximum, this is to say to decrease the range of tolerance at the highest level. The process will then be analysed starting at the target and going backwards. Actions necessary to manifest these goals will be looked for and a new process will be developed in a top down approach. In this procedure, the principles of the Failure Mode and Effect Analysis (FMEA) explained in Chapter 3 will be taken into account.

5.6 Integration of the Patient

In analogy to industrial process analysis, the patient will be seen as the process carrier. However, in contrast to industrial process analysis the process carrier is of active nature, influencing the process and even experiencing the process as discussed in Chapter.

5.7 Practical Procedure

1.The procedure will be divided into the following steps: 1. analysis of true patient quality characteristics; 2. analysis and modelling the potential quality of the patient; 3. defining the outcome quality; 4. analysis and design of the process quality; 5. analysing the potential quality of the clinic. 6. Finally, a best practise pattern of LASIK surgery will be presented.

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