QUALITY MANAGEMENT IN HEALTHCARE A EUROPEAN CHALLENGE THE GERMAN EXPERIENCE AMBULATORY SURGERY - HYGIENE FRAMEWORK CONDITION

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1 Cercetãri Experimentale & Medico-Chirurgicale Anul XIV Nr.2-3/2007 Pag Cercetari ) experimentale & medico-chirurgicale QUALITY MANAGEMENT IN HEALTHCARE A EUROPEAN CHALLENGE THE GERMAN EXPERIENCE AMBULATORY SURGERY - HYGIENE FRAMEWORK CONDITION Jacky Reydelet M.D. SUMMARY: Ambulatory surgery means all the operations where the patients spend the night before and after surgical procedures in a non-medical environment (IAAS - International Association for Ambulatory Surgery Venice April 1999). Quality management consists in prospective strategies for improving the quality. It is necessary to have a standard frame of management. There are a few important German laws, in convergence with European laws that try to make a standard and common basis for Ambulatory Medicine (Trilateral contract AOP, German Infection Control Act IfSG, Medical Device Directive MPG, Medical Device User Edict MPBetreibV, Quality management guideline for office based physicians and of the rules of Employers Liability Insurance Association). 1 - Kornwestheim Surgical Clinic, Germany INTRODUCTION The interest in quality management in health care is not only characteristic for our generation. In the early years of the Stone Age (Neolithic) B.C., our forerunners had unambiguously established an empirical system of quality in surgical procedures. The assessment of survival evidence after trepanation (building of callus) in different locations in Europe gave us the opportunity to appreciate the quality of intra- and postoperative care of our forerunners and to create a retrospective benchmarking of these first steps of ambulatory surgery. In general, quality assurance measures aim at maintaining standards agreed upon, quality management consists in prospective strategies for improving quality. In health systems quality strategies aim at optimizing the process of providing health care by identifying inadequate delivery of care and ultimately at influencing in a positive way the population s morbidity and mortality. The progress in medical care, the evolution of different systems in quality insurance, the globalisation and the integration of the countries in the constitution of Key Words: ambulatory surgery, quality management health impact assessment (HIA), hygene control policy. the European Union required a management standard frame. The first step of convention was made 5 years ago starting with the 1786/2002/CE decision (OJ L 271/ of October 9, 2002). The starting point in understanding the logic behind applying health impact assessment (HIA) within the EU is represented by the examining of the legal base of its activities. The Treaty of Rome (March 25, 1957 signed by Benelux, France, Italy, Luxemburg, the Netherlands, West Germany) stipulates, in Article 152, A high level of human health protection shall be ensured in the definition and implementation of all community policies and activities. This obligation is unique in terms of introducing a basic requirement considering possible health implications of measures and actions. Since this decision was made, the Community programme on public health has emphasised the developing of HIA work by supporting work on criteria and methods, such as guidelines and checklists, running pilot projects and fostering joint actions with other Community policies. National guidelines have to be in accordance with the target of the EC regarding above Correspondence to: Jacky Reydelet M.D., Langestr. 4-6, D Kornwestheim, Germany. 115

2 mentioned decision. The current period of convergence is running till December 31, The new members of the EC have to accept the rules and have to modify the national legislation in accordance with the EC decision. The parliament of Romania e.g. deliberated upon these changes during the 28/565 session from November 2, 2006, few weeks before Romania s integration in the EC. Since October 9, 2002 the evolution of German health legislation has observed as accurately as possible the EC decision. Important efforts were made for the optimizing of protection against infections, epidemic as well as nosocomials disease and for the setting of hygiene framework QUALITY FRAMEWORK FOR AMBULATORY SURGERY IN GERMANY German ambulatory surgery is currently predominant in free standing units - FSU (US ambulatory surgery centres ASC) with an average ratio FSU / Hospital of 75% / 25%. The legislation concerning FSU organisation accreditation quality management changed in 1994 according to the Treaty of Rome (1957) and the Treaty of European Union, TEU (Maastricht Treaty) signed in February 7, Ambulatory surgery is defined as the operations and procedures where the patient spends the night before and after a surgical procedure in a non-medical environment (International Association for Ambulatory Surgery - IAAS - Venice April 1999). Here, the court ruling is more restrictive and states: A surgical procedure is deemed ambulatory only within the meaning of Section 115 b SGB V (Book V of the German code of Social Law) if the patient spends neither the night before nor the night after the procedure in hospital. The Trilateral contract ( ) Since 1994 in order to qualify for a managerial position in ambulatory surgery, surgeons and anaesthetists have been asked of the Association of State Health Insurance Physicians/State Hospital Association of permission (trilateral contract mandatory declaration Section 3 - presently AOP that regulates ambulatory surgery in the hospital, contract - Extended Federal Arbitration Board Meeting of August 17, 2006 quality assurance agreement as per Section 115 b SGB V agreement on quality assurance measures for ambulatory surgery and ward-replacement procedures, including the necessary anaesthetics pursuant to Section 115 b (1) Clause 1 No. 3 SGB V - Section 3 mandatory declaration). The German Infection Control Act (IfSG) ( ) Hygiene aims at preventing infections, and in particular, in the medical environment at preventing nosocomial infections. The coming out of the German Infection Control Act (IfSG) on January 1, 2001 marked a milestone for the Federal Ministry for Health and Social Security (BMGS) in terms of regulating framework conditions governing hygiene, and of adapting them to the European regulations. Based on IfSG Section 36(1-2) all medical practitioners establishments are de facto obliged to implement these framework conditions. Office-based medical practitioners are required to formulate an infection control policy. Furthermore, from January 1, 2006 onwards this infection control policy must be integrated into the medical practices quality management system (Book V of the German Code of Social Law (SGB V) Section 135 a (2) - resolution adopted by the joint committee on October 8, 2005 Quality management guideline regulating contract physician service provision ). The Medical Device (MD) Directive (German MPG) and the Medical Device User Edict (MPBetreibV) ( ) T( ) The Medical Device Directive (Council Directive 93/42/EEC of June 14, 1993) concerning medical devices (OJ No L 169/1 of ) is intended to harmonize the laws relating to medical devices within the European Union. The MD Directive 1993 was modified and came into force on January 1, The Directive was reviewed in 2007 based on the edict from November 28, Physicians have to respect both, the directive and the edict especially the regulations referring to reprocessing of re-usable medical devices and employment protection (both according with the recommendation of the Robert Koch Institute RKI and the rules of the Employer s Liability Insurance Association - Berufsgenossenschaften). The aim of standardized reprocessing is to provide medical devices (MD) which are safe to use in terms of hygienic state and function. Quality assurance in reprocessing protects both patients and medical staff from the risk of infection and preserves the serviceability of medical devices. The cleaning, disinfection and sterilisation procedures must be validated. The procedures are applied to the processing of medical devices which have to be sterile or 116

3 with a low microbial burden upon usage. The successful completion of these procedures has to be well documented and archived. The Quality management guideline for office based physicians ( ) Office-based medical practitioners are required to organize a management of hygiene (IfSG ). Furthermore, from January 1, 2006 onwards this must be integrated into the medical practices quality management system (Book V of the German Code of Social Law (SGB V) Section 135 a (2) - Quality management guideline regulating contract physician service provision. The rules of Employers Liability Insurance Association The rules complete the complex system of our framework and regulate the protection of employees during workstation activities. PROBLEMATIC ISSUES On the1 of January 2001 the public health offices were appointed as supervising authorities pursuant to Section 36 of the Infection Control Act (IfSG). Some offices took their duties very seriously shortly after the act came into force. Thus, they distributed information material to ambulatory surgeons/anaesthetists and organised training courses and advisory sessions and provided specific information (mail shots were sent out to physicians; public health office staff participated in quality circles run by different specialist societies; questionnaires were sent out to medical practitioners; compilation of a harmonised Figure 1. Dispersion of German specialistic practitioners in 2005 infection control policy) and then supervising activities were initiated. Others had a different approach. Obstacles to harmonization of regulations include implementation of IfSG at regional level, the role of federalism - of lobbyism and of corporations, the weak economic situation as well as the Administrative Structure Reform Act (Werwaltungsstrukturreformgesetz) that came into force on the 1 of January, CURRENT RESULTS AND COMMENTS Methodology The Frankfurt Municipal Health Office placed e.g. a specimen infection control policy for medical practitioners establishments on the internet in April From March 2002 onwards, i.e. after the coming into force of the German Medical Devices Act (MPG), the Medical Devices User Edict (MPBetreibV) and the recommendations of the Robert Koch Institute (Hygiene requirements for reprocessing medical devices - Federal Health Gazette BGB 1 44, Nov. 200l: ), important measures were taken in order to initiate investigation of the practices that engaged in ambulatory surgery (99 FSU). A similar approach was taken in Erfurt where 41 practices were inspected between October 2001 and June 2003 and in Munich and Nürnberg regions where 31 establishments, 12 practices and 19 small clinics were inspected in Analysis (figures 1-6) The review of these systematic approaches shows discrepancies between the desired and actual state and CITY SPECIALITY PRACTICES CITY SPECIALITY PRACTICES Erfurt Surgery 11 München Small centre < 10 beds 19 Erfurt Urology 8 München ASC-practices 12 Erfurt Orthopedy 1 Vechta Internist / GP 12 Erfurt Ophtalmology 2 Vechta Dentist 11 Erfurt Dermatology 2 Vechta Gynecology 4 Erfurt ENT 2 Vechta ENT 3 Erfurt Max. facial surg. 4 Vechta Surgery 4 Frankfurt ASC 5 Vechta Dermatology 2 Frankfurt Single practice 67 Vechta Urology 2 Frankfurt Cooperation FSU 27 Vechta Pneumology 1 Total 199 practices (0.23% of all) : specialistic practitioners 117

4 Figure 2. Schedule for Hygiene - Infection control policy - Hygiene plan CITY CORRECT INSUFFICIENT NONE Erfurt 9? 32 Frankfurt München 21? 10 Vechta??? Figure 3. Rooms - Separation between Procedure / Investigation City Correct Insufficient None Erfurt??? Frankfurt 99 0 München Vechta?? Generally the architecture is in concordance with the recommendation of the Robert Koch Institute RKI Figure 4. Maintenance of MD Re-conditioning Instruments - Reconditioning 50% Insufficient City Correct Insufficient Erfurt Frankfurt München Vechta Figure 5. Maintenance of MD instrument cleaning equipment City Cleaning machine Manual cleaning and disinfection Erfurt?? Frankfurt 1 98 München Vechta 4 35 Precision: A cleaning machine is not asked especially in the German framework and by the way, it is expensive Figure (6) Hand hygiene - 37% Insufficient City Correct Insufficient Erfurt Frankfurt München 22 9 Vechta Precision: a correct hand hygiene is not expensive and it is mandatory the shortcomings in the service providers efforts to implement the legally mandated framework conditions for hygiene. Better results are to be expected in view of the fact that all ambulatory surgeons acknowledged the obligations that are set out in Agreement on quality assurance measures for ambulatory surgery and ward-replacement procedures pursuant to Section 15 of the contract as per Section 115b (1) SGB V linked to the trilateral contract (1994, 2004 and now 2006) and they pledged themselves they would comply with the conditions stipulated by the Association of State Health Insurance Physicians (KV). There are manifold reasons for the present situation: lack of basic knowledge of hygiene as far as the medical practitioners and their staff are concerned and of Quality management (Verpflichtung zur Qualitätssicherung) according to quality management system (Book V of the German Code of Social Law - (SGB V) Section 135 a (2) - resolution adopted by the joint committee on October 8, 2005 Quality management guideline regulating contract physician service provision ). lack of time and financial resources to implement the frame work conditions; failure of the executive of the self-administrative bodies (KV) (SGB V Section quality check in individual cases, trilateral contract 1 994/AOP contract quality assurance measures for ambulatory surgery, section 8 and 9 of the Federal and State Commission, quality assurance for ambulatory surgery); failure of the executive of certain supervisory authorities to discharge their duties IfSG Section 36, Section 16, Section 73 - MPG Section 25, Section 26). 118

5 Assessment of professional policies It is obvious that some FSU are having difficulties in implementing a management of quality and particularly, the hygiene framework conditions. Joint efforts should be made by medical practitioners, self-administrative bodies and supervisory authorities in order to organize and improve the present situation. The current remuneration does not reward good performances. Financial incentives are not available and there is no support for our efforts. We are called upon to invoke our ethics in times of pecuniary hardships. Unfortunately, patients know nothing about these prevailing circumstances and they could only trust the good reputation of healthcare service providers. The healthcare sector needs a ranking system, similar to the one established by Michelin Guide. As long as the executive continues to stagnate and as long as the remuneration system disregards the quality of FSU services, there will be no significant changes in the medical practices. INSPECTION (2003/2005) OUTCOMES CONTROLLING - CURRENT RESULTS AND COMMENTS Hygiene control policy unavailable till 50% Lack of respect of the Trilateral contract (AOP), of the German Infection Control Act (IfSG), of the Medical Device Directive (MPG) and of the Medical Device User Edict (MPBetreibV), of the Quality management guideline for office based physicians and of the rules of Employers Liability Insurance Association. 119