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3. Quality

Trust me,
I'm a doctor, isn't good enough.
We have to become more accountable.
Dr. Richard P. Mills

This chapter will explain the Total Quality Management philosophy. It will start with basic quality definitions coming from the industrial field, then enlarge the definitions that it applies to medical care. Tasks of quality policy, its purpose, goals and hints as to how to implement a quality system will be explained. The quality model for LASIK will be derived rather from the upper quality philosophies than from specific quality procedure norms applied for industry as the ISO 9000. In the author's point of view, it does not make sense to apply these derived norms to medical service and see what is going to happen. Instead, in the next chapter the specific nature of services is discussed and common quality models for services are introduced. Later on a specific quality model for ambulant surgery is built and applied to LASIK in Refractive Surgery.

3.1 Understanding Quality Definitions

There is a lot of confusion when talking about quality. Every author uses his own definition of quality and in discussions about quality improvements participants are not aware that everyone has his own view on how to handle quality. Moreover, cultural differences not only change the quantity of quality and the range of its indicators, but its meaning as a whole. It seems to be that the common German understanding sticks more to hard quality aspects, let's say producing the best no matter what it will cost and not caring about the emotional customers' satisfaction. The American understanding strongly involves the customers' wishes in its quality definition reflected by the importance of product research. The Japanese quality understanding also involves the customer, but statistical control is added which is to cut costs in the long run, and bring highly reliable products at reasonable prices.

Looking closer to the formal definition of quality by country's standardising institutes partly reflects the above observation.

3.1.1 German Quality Definition

The German DIN55350 defines quality:

"The entirety of properties and attributes of a product or service, relate to the suitability to fulfil given requirements."1

Although the definition makes the link to given requirements, it does not answer the question who will determine these requirements; will it be the selling company, their engineers, a person of unquestioned formal authority (in our case the ophthalmologist) or will it be the person who will live with the service or product respectively?

3.1.2 Japanese Quality Definitions

The Japanese JIS terminology standard Z8101-1981 defines quality control as:

A system of methods for the cost effective provision of goods or services whose quality is fit for the purchaser's requirements.
[Ish90p.1]
This understanding of quality includes the cost aspect and gives the answer of who decides on the requirements: it's neither the engineer nor a person of special authority, but solely the client.

Ishikawa even goes a further:

The quality that people will buy with satisfaction.
[Ish90p.16].

In order to fulfil this definition he recommends the following five attitudes [Ish90p.17ff]:

1. The four aspects of quality:
Q(quality): quality characteristics in their narrow sense.
Performance, purity, strength, dimensions, tolerance, reliability, etc..
C(cost): characteristics related to cost and price; cost control and profit control
D(delivery): characteristics related to quantities and lead times (quantity control)
S(service): problems arising after products have been shipped; product characteristics
requiring follow up.

2. Complaints:
There exist three manners to react to complaints: Old style companies often ignored complaints with the mentality that the client was lucky enough to be one of the rare owners of their unique product. Secondly, a company can start outside action- satisfying the customer on actual claims for compensation by free replacement, money compensation, etc.; the reaction is measured by speed and sincerity. Thirdly, a company can take internal action of actual claims and moreover of complaints unaccompanied by claims. The latter approach uses the vital and cheap information of its customers to improve its products. Recurrence prevention will lead to higher backward-looking qualities2 and the practical hints from their customers which are taken care of will raise the forward-looking qualities3.

3. The Deming Cycle:
The idea of this quality control cycle is really to utilise all the information gained during the life cycle of a product in its phase of planning and (re)design in order to guarantee built-in quality. As the picture illustrates, The Deming Cycle is like a forward moving wheel passing through the phases of design, production, marketing and after-sales service, then market surveys and taking care of all the experience gained for the next round. It needs to be mentioned that the effectiveness of the quality control cycle is determined by the weakest step like the strength of chain is determined by its weakest link.

4. The next process is your customer:
Fulfilling quality philosophies within in the company, Ishikawa recommends strongly that the following process in production must always be seen as a customer, e.g. taking all the responsibility that the work is properly done and will not cause any foreseen trouble in the following processes.

5. Quality control = Business management:
This wants to say that quality control is not a narrow tool which can be mutually implemented into a company in order to improve some specific aspects, but a means to improve the health and character of the company as a whole. For this it needs to be mentioned that quality control must be comprehensive to be effective.

J. M. Juaran differs between two types of quality, one called the quality of design which is the level of quality a company plans to achieve, and the other named quality of conformance which is the difference between the actual quality and its designed quality. Most people don't realise that for the latter, costs usually fall when the quality of conformance is raised due to defective decrease and productivity growth [Ish90p.34].

Taguchi is even convinced that overall costs are cut by decreasing the allowed tolerance rate demonstrated by his quality function L=D2xC, where L stands for lost profits, D for the deviation from the target and the C for the cost needed for production with no deviation. He reminds us that this is no natural law itself but an approximating formula which needs to be strongly respected [TC90p.38].

3.1.3 Meyers Definition of Quality

The German author Meyer suggests that quality must be interpreted widely:

It's also the sum of all the subjectively true judged beneficial expectations. All the additional kinds of gains, subjective opinions, ..., and the emotions, the belief, the judgements of the market partners. The two together, the group of the provable, and the group of the subjectively for true judged beneficial expectations determine the whole gain structure of a product or a service4.
[MM87p.187].
In the following we will assume quality in this widely broad definition as default, reference to other definitions will be explicitly mentioned.

3.1.4 Total Quality Management (TQM)

There are various understandings on Total Quality Management. However, here quality will be understood in the broad sense of Meyer. The Concept of Total Quality Control in the understanding of Ishikawa gives a structure of how to employ quality in a organisation successfully. Exchanging the term control into management takes the German reader into account. Germans confuse control with checking and supervision. Moreover, the term management demonstrates the challenge to act flexible, that is to say according to the situation. The situation is always determined by the interests of the customer. These are the true quality characteristic’s. Before employing any unquestioned quality standard true quality characteristics must therefore be found. The term total underlines the full commitment to quality management. Total Quality Management can never be successful, if it is done half-hearted. The term total also requires a top down approach starting with the true quality characteristics defined by the customer, before defining technical (substitute!) quality characteristics

3.2 Tasks of Total Quality Management (TQM)

Instead of directly applying a rigid quality scheme the real tasks of quality are to be discussed. Three questions must be answered: What for? How to employ it ? Which tools are useful?
3.2.1 Purpose of Total Quality Management

The purpose of Total Quality Management is outlined in medical service and in Refractive Surgery in particular.
3.2.1.1 In Medical Service

Surgery is an art,
which needs to be learned
science and technology
only gives the set up.

Cutting the cost explosion seems to be the major topic when western politicians are talking about the medical service sector. At first glance cutting costs seem to lower the quality of service. However, the academic medical community itself even abuses this argument to keep the status quo. For the average patient it seems logical that cutting cost will lower the service's quality. The result is that more and more awful, and often unneeded, diagnostic examination are given to patients, while time left for a personal diagnosis is minimised to a couple of minutes. Medical care is not only becoming less efficient, it is even becoming less effective as more patients cannot be cured by subscribing more drugs or pushing them from one machine's inversion to another.

The misleading myth is that costs can only be cut if quality is lowered. The opposite is true, but not wished for by the physician because it means significant change and induces a different attitude towards their patients. However, in the author's point of view it makes more sense to talk about improving the quality of health service, and the question of cost will be solved automatically.

Somehow, physicians are often seduced to believe that by buying the ultimate improvements in technology will make them significantly better physicians. It seems to be much easier to buy the latest technology than to be a really skilled doctor. It's true that technology is essential but training is even more important. Patients often seem to ask for the latest technology rather than asking the doctor to show his personal certified learning curve.

Quality can be measured on a macroeconomic scale by adding all the outcomes of people needing treatment. The best distribution and equal service for everyone is therefore of major importance and a must for macroeconomic quality approaches. Offering the best quality to only a few makes no sense. Although this will not be a topic of this work, it needs to be kept in mind, that any discrimination within medical services will reduce a country's medical quality.

Quality is strongly reflected by an individual patient's satisfaction and by the standards of results achieved. The developed quality approach in chapter six follows this double strategy of comparing outcome measurement with individual satisfaction measurement.

The major task of Total Quality Management is to assure that quality of conformance and quality of design are almost identical. Daily achieved quality must meet the possible quality.

However, its seems that the reality is far cry from this ideal. The KAP phenomenon describes this deficit. K stands for knowledge, A for attitude and P for practice. It seems to be very human, allowing for ease and laziness in confronting change to new achievements.

What are the reasons that knowledge is not implemented in daily practice?

Comparing the medical care situation with the western car industry, radical reorganisation in the car industry happened because significant outside pressure allowed knowledge implementation. If there is no essential need, nearly all reorganisation programmes have no effect. The built in importance for stability in organisations never gives a real chance for radical changes in 'good times'.

Medical care systems will only change, when there is a real fear from outside that the system is in real danger. Competitive structures could bring this necessary fear.

In the author's mind there are three major elements hindering the needed change: the abuse of ethics, the status of physicians, and under age treatment of the patient. It seems contradictory, but the noble ethic to save and to help every person in need, means that health care is seen as a gift never to be questioned, rather than a right to receive the best health care available. Many physicians behave like “gods” themselves, although they are only the service men for health. The high status of a physician in countries like Germany, practically forbids critic and control, and so the needed feedback for continuous improvement does not exist. Patients are often treated as under age, although patient motivation is an essential task of any physician. Long waiting lists give a good impression but in reality they are only a poor sign of bad distribution. Why are famous surgeons not motivated to serve as multiplying factors in training other physicians? It seems to be that internal rivalry and formal structures of responsibility hinder flow of information, training and the continuous improvement process. Maybe, the fear of being judged causes physicians to cover any information which might otherwise lead to improvements in quality and help prevent risks in the future. This pressure due to absence of patients and that communication between institutions are missing, hinders even more, quality in health care.

Future medical care needs to be managed around the patient. Physicians and clinic managers need to consider the patient's view-point. Instead of merely satisfying the wishes of the bosses, it is the patient who needs to be satisfied. The process the patient from entering the institution until leaving it needs to be optimised: short and pleasant stays, procedures which guarantee minimised risk of false treatment and best possible results. Well managed motivation structures using everyone's wish for respect, and team structures are vital for reaching highest quality.

3.2.1.2 In Refractive Corneal Surgery

After surgery:
driving at night
on German's autobahn
getting backlighted of
a BMW's light
will it still be safe?

Refractive Surgery is a fairly new field in medicine. Until a couple of years it was not taken very seriously due to missing tools and more important problems in other fields of ophthalmology. With recent developments and laser surgery, correcting ametropia might become as normal as getting rid of wisdom teeth and wearing brackets. Refractive Surgery is somewhere settled between needed surgery and cosmetic medicine. In many cases Refractive Surgery is an elective alternative to glasses or contact lenses. Whereas in essential medicine total quality 'can be a luxury', in Refractive Surgery it will be a market must: patients will not risk their vision for rather minor benefits.

If the individual has sufficient money and the country's ophthalmologic infrastructure allow good practical correction, the patient will take his best corrected vision as reference. In highly developed countries it will therefore be more difficult to persuade anybody to undergo surgical intervention whereas in third world countries poor patients will be pleased for any correction of the uncorrected vision to make gains in actual vision, as there is no money for optimal glasses or contact lenses.

Refractive Surgery in western countries, especially if the health insurance company does not pay for the surgery, will not harmonise with usual ophthalmologic practice. The elective nature of treating one's eye will not be possible within the five minute attendance of the patient. Information and education of the patient and the patient's selection process will be completely underestimated.

However, if total quality is strictly applied and there are no surgical or long time risks, Refractive Surgery will have a great impact and become one of the most common interventions.

If Refractive Surgery becomes a common intervention there will be another reason for TQM. It must be guaranteed that vision even in difficult circumstances is not damaged as a result of not wearing glasses. For instance, if the number of car accidents were to rise due to problems with driving at night, the intervention could not be allowed.

Applying quality control in Refractive Surgery will also meet the recommendation of the Joint Commission on Accreditation of Health Care Organisations (JCAHO, 1988) as it will be of high volume and high risk which are vital components to being identified as a tracer situation. The two major musts to be identified as a tracer situation.

3.2.2 Spots of Quality Management

Danger, obstacles and facilitators of employing quality in organisations are discussed.

3.2.2.1 Danger

What you have to watch out for!

closing up the market
Applying quality management brings the danger that side-effects are taken advantage of. If quality is not taken seriously, interest groups involved can use quality standards as better freecards for closing up the market, freezing their beneficial status quo with means of 'quality assurance'. Allowing Refractive Surgery to be done by ophthalmologists would be rather a 'political decision', whereas strict training programmes and the selection of only the best skilled surgeons would be quality management. Both approaches lead to discrimination, although in the second its only a result and not an unspoken aim.

scientist's dogma
If quality indicators are set by authorities, and are not evaluated through 'democratic' patient research and questionnaires then they are probably not representative. The set of quality indicators will either be to small or will not correlate to the satisfaction of the patients. In this case, quality management will present a danger, and might become an end in itself. Techniques which bring best results in typical clinical testing, but bring poor vision results at night, will not be questioned or even discovered at the time. Optimising the surgeries outcome to undesired targets will not be for the benefit of the patient. It produces additional procedures leading to patient discomfort and additional costs.

lowering risk by lowering goals
Lowering the risk of unsuccessful surgery might be achieved by simplifying the surgery. However, in some circumstances this -lowering responsibility- might lower the outcome of successful surgery. Lowering the risk potential by lowering precision might be a solution. However, combined with other interests this could lead off from the best track to minor results in the future. Missing training programs and the lack of skilled surgeons for the LASIK procedure could lead to further support for PRK instead of bettering the LASIK procedure.

avoid inflexibility
Traditional Quality Assurance can lead to inflexibility towards a changing situation hindering necessary change. Moreover, if TQM is applied superficially it only might cement inefficient procedures with time consuming testing procedures.

excess automatisation
Quality assurance realised through excess automatisation lowering flexible response and necessary identification of the personal will lead to lacking motivation and do anything but TQM. Abusing automatisation in the beginning of change might only 'cement' inefficient structures.

3.2.2.2 Obstacles

What you need to overcome!
confrontation with change
Implementing TQM to raise quality and lower costs, calls for a radical change in the organisation of medical care and of daily unquestioned procedures. The biggest challenge will be to convince all the staff to question and adjust their routines. Changing their daily targets to totally different targets will induce a lot of friction. Imagine Moslems to eat meat from one day to the other. Accepted norms of good and bad which are never questioned will have to be changed. The confrontations towards necessary change can be put into classes.

1.A staff member who will lose formal power
1.A staff member who does not understand the overall need for change
1.A staff member who sees the overall need, but does not realise its daily consequences
1.A staff member who has difficulties in forgetting former procedures

The first two groups are rather specific but the latter more or less cover every staff member. It can be said that older staff and more specialist staff, practising only a few procedures, tend to have more problems confronting change than younger or less specialised staff. Of course, procedures one has done for years are hard to forget, even more so if this means giving up one's own experience and giving the competitive advantage to others.

status of physicians
Physicians generally assume a high social position, as they are saving lives and our health. However, in some countries this position is boosted through government official privilege and missing financial dependence from their patients. It is not to be questioned that physicians possess a status of special dignity. However, this status may not lead to taboo criticism and practically forbid needed feedback structures for the continuous improvement process. Formal positions may not allow a physician to do what they do best, due to the system's inflexibility. Introducing TQM in medical care will question the typical hierarchical structures of physicians in clinics. Physicians of all positions will be confronted with internal feedback channels and with outside feedback from their patients.

thinking functionally
Taylorism has strongly influenced organisation in medical care. Structuring tasks with identical functions together makes sense as specialisation leads to higher efficiency. However, following this principle without questioning can lead to a very splitted process regarding the patient. Patients' time is then taken for granted. Today's information technology even more reduced the need for splitting patients journey into many stations. It is then still possible that patients only do their fully individual clinic journey without producing disorder or logistic problems. Taylor's principle of putting tasks with the same function into the same organisational division still makes sense if applied in second priority, patients interest must come first.

teamwork versus internal competition
TQM relies strongly on teamwork structures and takes advantage of group pressure. Individual competition or privileges not of beneficial outcome to the group, will be sanctioned by group pressure. However, good working teams rely on good communication between all members and the communication abilities of physicians are often rather poor. In addition, the lack of rationality and emotional gambling are to overcome when changing from competition to teamwork inside the institution.

progress is not linear, nor is it smooth
The organisational friction caused through the change will probably lower quality and raise costs in the beginning. It might take time the until real profits of the change to TQM can be seen. For every three steps forward, there may be one or two back. For almost any change and certainly for radical change, the learning process results in negative progress toward the goals before turnaround occurs and positive progress is made [AS94p.33]. Opposition can easily abuse this situation forcing a return to the former status quo.

3.2.2.3 Facilitators

Facilitators of implementing TQM in institutions make the usual obstacles look smaller and help to overcome them without getting caught by some of the risks mentioned above. These basically handle the human aspects of an organisation. The facilitators give a first set for developing a strategy of actual implementation and a realistic vision.

outside pressure: change or die
A crisis due to growing outside pressure will certainly help to overcome internal friction when implementing TQM. Groups of opposition will be easily unified to stand the threat from outside. Sometimes the outside pressure is not realised or seen by the members. Confronting its members with the outside pressure will then be the first thing to do to facilitate the needed change. However, sometimes, as in medical care, there seems to be no urgent threat. Simulation of outside pressure can then help. Often its even enough to point out a successful competitor. Members than compare themselves to the competitor.

leadership
Intention of change, introducing TQM, must be promoted by the highest leaders of the institution. Staff members must be shown that TQM is of major importance. Identifying a charismatic leader of the institution with TQM will help to motivate all staff members.teaching and workshops
Informing all members what the purpose of TQM's is, will be essential. Once staff have understood the concept and need of TQM, typical situations confronting change should be outlined. Small supervised workshops can than be a good solution to finding the best local process.

motivation
Involving staff in decision making will help making friends with TQM. Moreover, localised knowledge will bring better results than giving orders from above which do not suit the situation. Local staff know their own situation best. Applauding early progress will close the circle for further motivation and improvement.

the right step at the best time
Handling the different obstacles to change, and the different classes of staff opposition needs a well planed and flexible strategy. All steps from the introduction to final the implementation need to be well thought out. The order and timing of each is of upper most importance. Many obstacles can be surpassed intelligently or even changed into 'supporting friends', but it can also easily happen that obstacles are provoked to join together to form walls which are difficult to overcome.

KISS: keep it simple and stupid
Changing rules and changing habits cost everybody additional energy. Nobody is willing to change his habits to more difficult procedures. The new procedures already have the disadvantage that they are unfamiliar, and this by itself makes them more complicated than the old ones. However, if staff can see that after a short period of time, everything will be easier and even more fun, then they might expend the additional energy needed to change to the better. New tasks which seem too complicated for daily procedure will not survive the introduction. They even might become symbols of the unwanted change. Some procedures might seem complicated in the beginning and yet very simple after a period of time. It is particularly important that the explanation and teaching of these procedures is good and kept easy, so as to shorten the dangerous time of friction and learning. New procedures must be easier than the old ones and they must be explained well to overcome the critical time of getting used to them.

3.2.3 Methods for Realisation

The focus of TQM is on process engineering to greatly improve quality and satisfaction of the client. Implementing TQM means starting at the clients' wishes and going backwards to the business process. This approach will guarantee the lowest rate of expensive surprises, higher quality standards, lower costs and it will automatically keep the focus on the essential: serving the client.

In the last decade their have been many concepts for restructuring organisations like 'just in time' or cutting middle management. TQM includes many of these partial concepts implicitly, but in TQM they are not a goal in itself. Newer concepts such as reengineering or continuous improvement process have much in common with TQM. They all focus on the client and on process optimisation/rethinking. Reengineering is rather an Anglo-American radical approach whereas the Japanese continuous improvement (CIP) process refers to small improvements on a day to day basis. Reengineering and CIP can be used as excellent methods for the implementation of TQM. However, they can not be used at the same time. The order is essential. Reengineering will help to find and select the new track and CIP will help to follow this new track. Doing CIP before doing Reengineering is like smoothing the wrong track. Computer Integrated Manufacturing (CIM) further improve quality. Once the quality standards are set CIM's Computer Added Quality (CAQ) is useful to assure the standards.



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