PDF Leitlinien - ein Instrument zur Qualitätssicherung im Total Quality Management (German Edition)

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Please refer to the corresponding guideline chapters for a detailed justification and statement [ 3 ]. The general quality parameters for endoscopic examinations are summarised in table 1 [ 3 ]. The German guideline mainly foregoes indicating defined cut-off values, particularly for quality parameters that are generally accepted, legally claimed, and logical evidence level III; expert opinion even without any study-based evidence. A documented indication is required for an endoscopic examination or intervention to be performed. Adequate indications exist if a diagnostic or therapeutic consequence results from the examination or if a therapeutic procedure has primarily been considered.

Individual indications can be found in disease-specific guidelines and in the recommendations of the German Society for Gastroenterology, Digestive and Metabolic Diseases DGVS [ 6 ] and other professional societies [ 7 ].

A punishable offence and civil liability can only be omitted if the patient has provided an effective consent. For patients to be able to effectively consent to an intervention while respecting their freedom to make own decisions, they must be informed in detail about the risks related to the medical intervention and be able to consider the principles of the case law [ 8 ]. The central function of the informed consent is, therefore, to explain the form, meaning, course, and consequences of a planned intervention to the patient and to document this accordingly.

Patients must be informed in a timely manner so that they can decide on their own whether the intervention should be performed [ 3 ] chapter 3. In , a multicentre study was performed worldwide and examined the efficacy of this WHO checklist [ 10 ]. The WHO checklists were used for 3, patients before the surgery and for 3, patients after the surgery. The complications occurring within a time window of 30 days after the OP were used as an indicator. Using the WHO checklist, it was possible to achieve significant reductions in severe complications, infections, lethality, and mortality in these patients.

This can also be transferred to endoscopic interventions, for which the preparation of the patient should also be done by applying a standardised risk assessment identifying the patient's risks related to the intervention and sedation. The rate of infections with multidrug-resistant pathogens is increasing worldwide.

In particular, the increase in resistant intestinal pathogens needs to be mentioned multi-resistant Gram-negative MRGN pathogens. Thus, a moderate, evidence-based use of antibiotics is also required for prophylaxis. On the other hand, the administration of an antibiotic AB prophylaxis decreases morbidity and mortality for targeted indications and is a measurable parameter.

The current guideline [ 3 ] chapter 3. This also applies for a bridging and renewed administration of the medication. The procedure should also be documented. The current guideline also provides concrete recommendations for the handling of new oral anticoagulants NOAK [ 3 ] chapter 3. The team time out verification process done immediately before starting the procedure is a useful instrument to prevent an adverse event and complications, and to enable a smooth, target-oriented intervention [ 9 , 10 ]. Directly before the endoscopic intervention, details of the patient's risk, preparation, and intervention are queried in a summarised form and documented.

The US guidelines on the sedation and care record also mention the team time out as an additional review instrument beyond the pre-endoscopic risk assessment [ 15 , 16 ]. Image documentation needs to be standardised and patient-related. Furthermore, the image documents should be stored according to the legal requirements and, if applicable, should be submitted to the competent self-governing bodies for quality control reasons [ 18 ]. The time recording of the examination and intervention process includes the time spent for the intervention itself and the time spent on the corresponding preparation and follow-up.

The input of time and personnel for each endoscopic intervention should also be shown [ 3 ] chapter 2.

This has already become a self-evident fact in the surgical field and it is an important basis for adequate imbursement. The time recording programs used should preferably be equipped with a time stamp function time-based record. The German S3 guideline on sedation [ 6 ] recommends documenting specific parameters in a structured way before the transfer or discharge of the patients. Corresponding checklists objectively ensure reproducible processes and further support patient safety. The completeness of the documentation of medical data is based on the one hand on legal implications [ 19 , 20 ], but is also the basis for a quality control [ 21 ].

The documentation of the complete treatment process should include the following aspects:. Another important quality attribute is the set of recommendations regarding the follow-up with information on monitoring, transition to a normal diet, possible continuation of anticoagulants, and the further proceeding.

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The documentation of the instruments and materials used and an identification of the disposable material used via barcodes must be performed according to the standard. This ensures a traceable documentation of the materials with respect to the hygiene requirements [ 3 ] chapter 6; [ 22 , 23 , 24 ] and the withdrawal modalities. The documentation of intra-procedural complications is an important quality attribute for the intensity of the monitoring and further therapy of the patient, if applicable.

The documentation of the frequency of specific intervention-specific complications intra- and post-procedural is another quality parameter. To document valid data, an active follow-up of the patient may be required, in particular regarding the documentation of late complications e. Examples for intervention-specific complications are stated in chapter 4 of the guideline [ 3 ] under the individual procedures. A complete oesophagogastroscopy includes the evaluation of the oesophagus starting from the upper oesophagus sphincter up to the duodenum part II and is a quality attribute [ 25 ].

Most of the studies on the diagnostic work up of pre-malignant lesions in the upper gastrointestinal tract investigated the additional use of contrast enhancement and magnification compared to SD standard white light or HD high definition endoscopy. Studies using HD endoscopy failed to show a significant benefit for additional chromoendoscopy real or virtually in the detection of dysplasia in squamous cell carcinoma and Barrett's oesophagus [ 26 , 27 , 28 , 29 ].

The current ESGE guideline does not classify the white light endoscopy SD as sufficiently exact in differentiating and diagnosing pre-neoplasm conditions and lesions Helicobacter pylori HP gastritis, atrophic gastritis, intestinal metaplasia ; thus, the use of the best available endoscopy technique and the collection of sampling biopsies in the endoscopic monitoring are requested for patients with a precancerous condition [ 3 ] chapter 4.

Endoscopically suspect lesions include changes of the mucous membrane caused by inflammations, ulcers, tumours, and infections.

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The diagnostic and monitoring of precancerous conditions relates to Barret's oesophagus but also to the atropic gastritis with or without intestinal metaplasia [ 30 , 31 ]. In these cases, the recommendations for the indication and sampling of endoscopic biopsies refer to the current guidelines of the professional society [ 6 ]. Antibiotic Prophylaxis in Acute Variceal Bleeding: The administration of an antibiotic prophylaxis in acute variceal bleeding significantly reduces morbidity and, therefore, should be performed [ 3 ] chapter 3.

A significant improvement of the initial bleeding control and 5-day haemostasis has been proved for the administration of vasopressin analogues in cases of acute variceal haemorrhage [ 3 ] chapter 4. Endoscopic band ligation should preferably be performed in acute oesophageal haemorrhage as the first-choice procedure. Furthermore, band ligation is the first-choice procedure in the endoscopic primary and secondary prophylaxis of oesophageal variceal bleeding [ 3 ] chapter 4. The endoscopic band ligation treatment should be periodically performed until eradication.

Subsequently, regular endoscopic controls should be undertaken and, if applicable, a renewed ligation therapy if recurrent varices are found. Complete eradication of oesophageal varices with band ligation every weeks is achieved after sessions [ 3 ] chapter 4. If acute ulcer bleeding is suspected, therapy with PPI should be administered immediately, independent of the time of the endoscopy. The Cochrane meta-analysis [ 35 ] shows the benefits of this procedure with regards to the rate for bleeding stigmata and the number of the required therapeutic interventions [ 3 ] chapter 4.

Total Quality Management TQM

Several meta-analyses and a Cochrane analysis [ 36 , 37 , 38 , 39 , 40 ] dealing with the endoscopic therapy of peptic ulcer bleeding revealed that the combination with a second haemostasis procedure haemoclip or thermal procedure is superior to the injection therapy alone with regards to the recurrent bleeding rate and the requirement to perform surgery [ 3 ] chapter 4. In light of the data from a Cochrane analysis [ 41 ] and a meta-analysis [ 42 ,] a high-dose PPI therapy cannot generally be recommended for each case of peptic ulcer bleeding, but it seems to be justified if a high-risk bleeding stigmata is present.

If the HP test was not already performed during the acute endoscopy, the report should recommended it be done [ 3 ] chapter 4. The Boston Bowel Preparation Scale is the most frequently used validated score [ 43 , 44 ]. The quality of the preparation needs to be documented not only for legal reasons.


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If a bowel is badly prepared, the need for repetition of the colonoscopy has to be discussed with the patient. If the adenoma detection rate is taken as the main surrogate parameter for the outcome quality of the colonoscopy as few not-detected carcinomas as possible [ 47 , 48 ,] this justifies the recommendation that a repeat colonoscopy is necessary in cases of bad bowel preparation [ 3 ] chapter 4. A Canadian database evaluation of 1, interval carcinomas revealed that endoscopists with a high caecal rate and those with a higher polypectomy rate related to account data detected significantly fewer interval carcinomas and this in an almost linear correlation [ 49 ].

With respect to the withdrawal time, several larger studies showed a positive influence of longer withdrawal times on the adenoma detection rate. Despite being high-level publications, it should be stated that these studies were possibly post-hoc analyses and not prospectively planned studies as there was no prospective time measurement, e. For this reason, only negative colonoscopies with no polyp findings requiring a biopsy or resection have been used for the documentation of the withdrawal time [ 3 ] chapter 4. A correlation of the adenoma detection rate ADR, rate for patients with at least 1 adenoma is plausible despite the limitations of the present studies.

Analysis of the literature shows, in a model calculation for interval carcinomas, a mean rate of 0. In contrast, de novo carcinomas not having been detected nor resulting from non-detected carcinomas are evaluated as very rare [ 51 ]. It should be explicitly stated that the ADR as a quality parameter is only established for prophylactic colonoscopies, and, thus, it cannot be correlated directly to the diagnostic colonoscopy. According to the available data, symptoms such as abdominal pain partly termed irritable colon , diarrhoea, and, in particular, constipation show a more or less similar ADR as that of the prophylactic colonoscopy [ 3 ] chapter 4.

The completeness of the polypectomy should be controlled endoscopically. In this case, the suggested follow-up intervals are given in the recommendations of the DGVS guidelines on colorectal carcinoma [ 6 , 7 ]. In the case of a piecemeal resection, biopsies from macroscopically normal scar areas should also be performed during the first endoscopic follow-up.

Resected lesions should be sent for histological examination and the localisation should be indicated. If this is not possible in single cases, this should be documented in the report.

General Quality Parameters

The histological evaluation of resected polyps should be considered as standard with regard to the current standard of knowledge. Up to now, this policy is limited to polyps of less than 5 mm for risk assessment reasons. These considerations are based on several studies of endoscopic differential diagnosis using pit patterns and a virtual chromo-endoscopy, with normally very good results [ 56 , 57 , 58 ]. The uncertainty in differential diagnostic between hyperplastic polyps and sessile serrated adenomas complicates the topic, in particular, with regards to the prognostic meaning.

Therefore, the guideline recommends sending resected lesions for histological examination indicating also the localisation. The rectal application of mg diclofenac or indomethacin before and after ERCP with papillotomy is well proved for the prophylaxis of a post-ERCP pancreatitis PEP and should be applied as standard [ 3 ] chapter 4. Documentation of the Fluoroscopy Time and Dose: A large meta-analysis analysing more than 8, publications regarding quality criteria for ERCP included 52 qualitatively adequate prospective and retrospective studies [ 64 ].

The cumulative success rate for bile duct cannulation was A pre-cut was applied in Employee-related measuring of quality 1.

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Quality Management is of utmost important for every company, hotel business etc.. Quality Management, short QM. QM stands for everything that should develop into a positive direction. This is the main reason why I would like to work on that issue. The article gives an outline of my visionary view of Quality Management referring to the hotel business. Generally, quality management is a leadership task. The objectives of quality management in hotel business are to be derived from superior business targets such as profit, profitability and safeguarding of competitive advantages.

The targets of quality management may be subordinated to marketing objectives. In order to realize marketing-oriented targets it is necessary for the hotel respectively the restaurant to have information about guest-relevant criteria of service performance quality and its valuation. Information must therefore be assessed internally as well as externally and transposed into quality standards of guest service. The different perception of quality characteristics by the guests and by the staff members makes the formulation of requirements on the quality of a service company more difficult.

In hotel business quality can be broken down into 5 evaluable categories, which can be assigned to specific fields in hotel and restaurant service performance. The five dimensions of quality in hotel and restaurant business can be seen as follows:. However, the requirements on service depend on the target group that often is not homogeneous. Therefore, requirements often cannot be formulated generally. The planning and reaching of a superior quality level - seen from the view of a customer or a guest - is therefore a complex optimization challenge in business practice.

Numerous features of quality must be chosen, classified and weighed. Hence result single requirements that have to be made concrete in order to fulfil specific guest desires. Looking ahead we should always have prevention of mistakes in our mind, because this is the best way towards quality improvement. Customer-orientated quality of service performance is if there is an agreement of service with a benefit in mind, which is subjectively seen by the guest.

In order to prove in how far the service provided is due to the quality standards required there usually various objective and subjective methods are applied. A generally favoured objective method in hotel and restaurant business is that a test customer anonymously consumes the service offered. This method is applied for example by testing persons of various restaurant and hotel guide-books.

Then the results are published in relevant magazines. The observation by experts as another objective method has got a disadvantage: the persons involved often are informed in advance, they do not behave as normal customers and staff members; the expert often judges as an expert and does not take into account the emotional view of a real customer. The feature-oriented subjective measuring generally consists of a homogeneously structured questionnaire.

Thus, the questioned person judges standardized situations by means of a scale. This method, however, is not able to take into account the key experiences, which eventually have arisen during the service process and which particularly are recognized as quality relevant by the guest. In order to assess also such events, in business practice therefore only more complex, result- orientated methods can be applied for example making interviews to make the whole service performance process visible together with the customer.

By means of quality audit service performance quality is not evaluated directly, but objectives, structures and processes, which are related to them.