The principles of quality assurance: report on a WHO meeting, Barcelona, 17–19 May 1983

t:J'~;,'f World Health Organization -/.. ~ Regional Office for Europe ~ ~ Copenhagen ~ ~ I t EURO Reports and Studies 94 The principles of quality assurance Report on a WHO meeting Barcelona 17-19 May 1983 ICP/ SPM 044 ISBN 92 890 1260 9 © Wo rld Hea lth Orga ni za tion 1985 Publica tio ns of the World Hea lth Orga ni za tio n enj oy co pyright pro tectio n in accorda nce with th e prov isio ns of Pro toco l 2 of the Universa l Copyri ght Co nven- ti o n. Fo r rights of reproducti o n o r tra nsla tio n, in part o r in 1010. o f publica ti ons iss ued by th e WHO Regio nal Office fo r Euro pe a pplica tion sho uld be made to th e Regio nal Office fo r Europe, Scherfi gsvej 8, DK-2 100 Copenh age n 0 , Denma rk . T he Regio na l Offi ce we lco mes such appli cations. T he designa ti ons empl oyed a nd the prese nta ti o n of the materia l in this pu bli- ca tio n do no t impl y the express ion of a ny opin io n whatsoeve r o n the pa rt of th e Sec reta ri a t of th e Wo rld Hea lth Orga niza ti on co nce rnin g th e lega l status of any co untry, territo ry, cit y o r a rea o r of its a uth orities, o r co nce rning th e de limita ti on of its frontiers o r bounda ries. The menti o n of specifi c co mpanies o r of certa in manu fac turers ' products does no t impl y that they a re end o rsed o r reco mm ended by th e Wo rld Hea lth Orga ni z- a ti o n in preference to o th ers of a simila r na ture th a t a re no t menti o ned . Erro rs and o miss ions exce pted , the names of proprieta ry products a re distin guished by initi a l ca pit a l lett ers. The views ex pressed in this publicati on a re those of the part ici pa nts in the meeting and do not necessa rily represent the decisions o r the sta ted po licy of the World Health Orga ni za ti on. PRI NTED IN DEN MARK ISSN 0250-8710 CONTENTS Page Introduction Scope a nd purpose Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Why is quality assurance needed? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Professiona l motives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Socia l motives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Pragmatic motives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 What are the objectives of quality assurance? . . . . . . . . . . . . . . . . . . . . 4 Public accountability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Ma nageria l improvement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Facilitate adoption of innovat ions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 How can quality assurance best be introduced at the national and local level? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Consider fin ancial a nd legal incentives and disincentives . . . . . . . . . . . . . . . . 7 Devel op public support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Stimulate p rofessional curiosity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Train students . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Develop suppo rting materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Develop suppo rt a mo ng insti tutional administrators 9 Consider development of legis lation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 What activities should be included in a national quality assurance programme? . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Monito ring of care II Assessment of problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Level of o peration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Education of health professio nals 13 Resea rch and development in qualit y assurance . . . . . . . . . . . . . . . . . . . . . . IS Informatio n systems development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IS Ho w can quality of services, if found defective , be improved? . . . . . . 16 Consider rewa rd systems 16 Be aware of habit patterns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Avoid punitive strategies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I 7 Use met hods of o rganizationa l cha nge . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Conclusions and recommendatio ns 19 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Annex I. Participants 23 Summaries in French, German and Russian . . . . . . . . . . . . . . . . . . . . . 25 I TRODUCTIO The Wo rking Group o n the Principles o f Qua lity Assurance was convened by the WHO Regio na l Office for Europe and met from 17 to 19 May I 983 a t the H osp it a l de la Santa C reu i Sant Pa u, Barcelona, Spain. The 18 participants and 6 observers included physicians as we ll as indi vid uals with professional backgrounds in nursing, economics , biostatistics and hosp ita l adm ini st ration. In addition, th ere were severa l government hea lth officia ls, medical educators and public hea lth educators . Mr Lluis Bohigas, Head of the Service of Hea lth Ca re Planning, Ca ta lan Ministry of Hea lth was elected Chairman and Dr William J essee ac ted as Rap- porteur. The li st of participants is given in Annex 1. Scope and purpose Starting from th e assumption that quality ass ura nce is a relatively new but highly des irab le co ncep t in the Euro pea n Membe r States of WHO , the Working Group was charged wi th the responsibility of sugges tin g a strategy for presenting quality assurance to national health au th orities, health professionals, the sc ient ific community, and the consumers of health se rvices. The Group a tt empted to analyse and answer th e fo ll owing questions: why is quality assurance needed; what a re its objec ti ves; how can it be bes t int rod uced a t the na ti o na l and loca l leve l; what ac ti viti es sho uld be included in a na tio na l quality ass urance progra mm e; a nd how can the qualit y of serv ices, if fou nd defective, be improved? The rec- o mm enda ti o ns the Workin g Group made sho uld facilitate the ultima te objec tive of deve lo ping comprehensive syste ms for quality ass urance as a n essential component of the hea lth ca re d elivery sys tem. BACKGROUND Alth ough the World Health Assembly and the Regional Committee have passed no resolutions explicity menti o ning qua lit y ass urance, WHO's mandate to consider qua lit y- related issues is clear. Qua lit y of ca re is implic it in the WHO Constitution, in the Sixth a nd Seve nth General Prog ra mmes of Wo rk , a nd in the man y recommendati o ns pertaining to the es ta bli shm ent of no rm s and s ta ndards, a nd to health se rvices eva luation. There is a lso clea rl y a growi ng interes t in quality assurance a mo ng the Member States, both in Europe and in ot her areas. The c urre nt WHO co nce rn with quality assurance is a natural and logical ex tension of revious ac ti viti es tha t have renec ted thi s implicit mandate. The vario us repo rt s and recommendati ons of wo rking groups conve ned by the Regio na l Offi ce co nta in increasingly frequent references to the eva lua ti on of the quality o f hea lth se rvices a nd th e effec ti ve use o f ava il a ble reso urces. Early in the evo luti o n of WHO, th e no ti o n prevailed tha t eve ry individual was entit led to th e best th a t medicine could offer. Gradually, howeve r, a mo re resource- and cos t-o ri e nted view has emerged emphasizing cost-effec ti ve ness as well a abso lute standards of quality. The WHO Regional Office for Europe has assumed a position of leadership in at tempting to facilitate the efforts of the Member Sta tes to develop their own approaches to q ua lit y assu rance in th eir health care sys tems. Earlier WHO ac ti vities that have addressed thi s issue have in- cluded the publicati on of a book on qua lit y assurance ( I) and the co- ~ponsorship of a symposium on health ca re quality assurance method- ology in Utrecht. Netherlands, from 18 to 20 October 1982. The present Worki ng Group is a logical extensio n of these ear li er act iviti es. This report is int ended to st imula te fur ther the interest of the Euro pean Member States a nd to faci litate co mmunica ti o n a mo ng workers in quality ass ura nce. Despite the intense level of interest in quality ass urance, the top ic remains a novel and often nebulous concept for most European health professionals. A lth ough there is an abundance of American literature on qua lit y ass urance methods, the approaches used a re often so specific to th e American health se rvices system that their transla ti on to the va ri o us sys tems in Europe is difficult or impossib le. Accordingly, th e Workin g Gro up a tt empted to draw prim a ril y on the ex periences of ten Europea n countri es, while not igno ring lesso ns from the American expe ri ence, to develop princip les for the evoluti o n of improved quality ass urance ac ti v- ities in Europe. 2 WHY IS QUA LITY ASSU RANC E NEEDED? The answers to thi s questi o n a re fundamental to establishing the ra ti o na le for quality assurance ac tiviti es in the health care sys tems of WHO Member States. The answers will vary, however, accord ing to the audience that poses the question. There see m to be three separate sets o f motives that require attention, a nd that individua ll y a nd collec tively answer the question of "why?". Professional motives Profess iona l motives for quality assura nce a re of key importance in mo- ti va ting hea lth care practitio ners to beco me involved in quality assurance activities. One of the elements of professio na lism is the desire to be self-correc ting and se lf-regula ting. In addi ti o n, altruistic motives for m a n important part of the profess iona l ethi cs of all the hea lth ca re professions. Accordingly, qua lity assurance can be see n as a n important means fo r hea lth ca re practiti o ners to identify their deficiencies a nd , therefore, their educational needs. Similarly, participation in quality assurance ac ti vities ca n create a n environ ment of professiona l cha llenge and resul t in growth for hea lth ca re professionals. The active participation of health care pro- fessionals in programmes to improve the quality of services can be an important mechanism for anal ys ing and explaining differences in patterns of practice and results of care . These differences in performance can stimulate the intellectual curiosity of health care professionals, and be a first step towards im proving their performance. Social motives A seco nd mo tive for quality ass ura nce ac ti vi ti es is the need to be acco un- ta ble to soc iety fo r the funds spent to purchase hea lth se rvices. An equally important soc ial motivat io n is to ensure the safe ty of the public, a nd to protec t the public from care that is ina pp ro priate, suboptimal, or ha rm- ful. A growing bod y of evidence see ms to indicate th a t the incide nce of iatrogenesis is substantial in western nati o ns, poss ibly as a consequence of the rapid expansion o f tec hno logy (2,3). Accordingly, quality ass ura nce programmes must be developed so that the ri sks inheren t in modern medical practice can be identified a nd controlled , thus max imizing the benefits to patients, while ensuring that unnecessa ry risks a re avo ided . Some have even suggested that the terms "efficiency" and "effectiveness" of care might be substituted for "quality" of care to indica te the im- portance of evaluating not only the results achieved, but also the efficient 3 allocation of financial resources in achieving those results. This, too, forms a rationale for the development of quality assurance systems to assure social accountability. Pragmatic motives Finally, a set of pragmatic motives related to the proliferation of infor- mation and to the possibility that patients may either be denied avai lab le services or injured by excessive or inappropriate services, makes it essential that quality assurance programmes be developed to reduce patient suffer- ing. It is amply consistent with the mission of health care, and with the definition of health contained in the WHO Constitution , to have pro- grammes designed to identify problems and continually to advance the performance of health care systems. This objective of quality assurance programmes can be achieved only with the active involvement of health professionals and the continuous support of health care delivery sys tems. The Working Group felt that a major objective of quality assurance activities was to avoid adverse impacts on physical , mental and socia l wellbeing. WHO could assist by promoting an international comparison of methods in this rapidly developing field. This coordination of infor- mation and dissemination of results from the various Member States could help ensure that mistakes are not repeated and that lessons learned are shared. In addition, the involvement of WHO could formalize the interest in quality evaluation and quality improvement that has often been stimu- lated only by isolated individuals. One important prerequisite for the further development of quality assurance activities throughout Europe will be the development of a critical mass of interested health professionals and policy-makers in each of the Member States. In this, the support a nd involvement of WHO will be critical. Finally, the improvement of health care data , especially infor- mation used in planning, will be an important side-effect of greater in- volvement in quality assurance activities and permit health planning to proceed from a more accurate information base. WHAT ARE THE OBJECTIVES OF QUALITY ASSURANCE? In attempting to define the objectives of quality assurance programmes, it is important that a consensus should be reached at the outset about what is to be defined as "quality". Although there is extensive literature on ap- proaches to a definition of quality in health services ( 4), a general con- sensus has not yet emerged among health professionals regarding an 4 appropriate operational definiti o n . This has handica pped effo rts to de- velop effective qualit y assurance progra mmes, as individual efforts have produced personal definitions that are often inco mpa tibl e with o ne another. Four pa rticular components must be addressed in a ny effort to deve lo p an effec tive sta tement of th e objec ti ves o r co ntent of quality ass urance activiti es: professional performa nce (technical qua lit y); resource use (efficiency); ri sk management (the ri sk of injury or illness associated with the services provided ); pa ti ent sa tisfactio n with the serv ices provided. Inco rpora ting these four eleme nts, o ne might then a tt em pt to define the object ives of a quality assurance programme as: to ass ure that each pa tient receives such a mix of diagnostic and therapeu ti c hea lth services as is most lik ely to produce the optimal achievable health ca re o utco me fo r tha t pa tient , cons isten t wi th th e sta te of th e a rt of medical sc ience, a nd with biological fac to rs such as th e patient's age, illness , co nco mitan t secondary diagnoses, compli a nce with the treatmen t regimen , and o th er related factors ; with the minimal expe nditure o f resources necessary to ac- co mplish this result ; at the lowest ac hievab le ri sk of add iti o na l injury or disa bility as a conseq uence o f the trea tment ; and with ma xi ma l pa tient sa tis- faction with the process of ca re. his/her interac ti o n with the hea lth care sys tem , and the results o btained. While an individual qualit y assurance act1v1ty need not necessarily address a ll four components of thi s definition , it is important that the overall quality assurance programmes mounted by institutions or coun- tries give equal cons ideration to the importance of each. Exclusive atten- tion to on ly one of these four components cou ld lead to invalid conclusions about the quality of service and to faulty programme or policy decisions about the allocation of resources or future directions for the health care delivery sys tem . Public accountability One of the principal objectives of quality assurance programmes is to provide a mechanism for the public accountability of the health services delivery system, since substantial proportions of all health se rvices are currently financed from public sources. In every European Member State, it is critical that quality ass urance activity should provide objective evi- dence that funds are being spent both efficient ly and effective ly. In this 5 sense, quality assurance act ivities can focus on both the efficacy and the efficiency of the care provided, to validate the concerns of the public about the expenditure of resources, as well as to improve the o perational efficacy and efficiency of the services provided. Managerial improvement Public accountability leads to a second important objective of quality assurance programmes: their use as a managerial tool for problem solving in health care organ izations. Although considerable jargon has grown up in the quality assurance field, it remains fundamentally a simple process of identifying and solving problems. Accordingly , as part of the managerial process in institutions or multi-institutional systems, one of the principal objectives of quality assurance must be to identify the problems that affect any of the four components of quality noted above (technical quality , efficiency, risk, or patient satisfaction); to assess the nature of those problems and attempt to identify the causes; and finally to faci lit ate effective managerial actions to reduce or eliminate the problems so ident- ified . In this context , it is clear that quality assurance activities cannot be isolated from the line management functions of health care institutions and organizations. Ideally, quality assurance should be incorporated as an integral management component at each level of o rganizational function. In particular , it is vital that each clinical department within a health care institution or organization consider quality assurance as part of its general responsibil ities, rather than as a merely academic exercise removed from the everyday provis ion of clinica l health services. Facilitate adoption of innovations A third objective of quality assurance programmes is to facilitate the process of inn ovation in health services delivery. Through the process of eva luating the performance of health care professionals and bringing them together to discuss appropriate criteria for assessing the processes and outcomes of health care, innovations (such as technological advances) can be brought to their attention and more rapidly dissem inated and incor- porated into practice. Similarly, innovations in the organization, admin- istration, and operation of health care facilities and organizations may be propagated through the evaluat ion of the impact of such activities on patient care outcome , efficiency, risk and satisfaction. Quality assurance activities can fac il itate the exchange of information within and among health disciplines. By using the patient as the unit of analysis, the success of the health care system in achieving the four content components and the various roles and responsibi lities of the members of the health care team can be more clearly 6 identified and their interac ti o ns to improve hea lth ca n be fac ilit a ted . Bringin g a bo ut a clear understa nding o f the ro les o ft he va ri o us di sc iplin es in achiev ing o ptima l hea lth ca re a nd the co ntributi o ns th ey ca n ma ke ca n be a c ritical step towards mo re co mprehe nsive a nd effec ti ve hea lth se rvices. HOW C AN QUALITY ASSURANC E BEST BE INTRODU CE D AT TH E NATION A L AND LOCAL LEVE L? Th e imple menta ti o n o f qua lit y a sura nce p rog ra mm es in o rga ni za ti o ns o r th ro ugho ut hea lth ca re syste ms is a n inn ova ti o n tha t is s ubject to a va ri e ty o f types a nd so urces of res is ta nce . Acco rdingly, it is ex tre mely impo rt a nt tha t ca reful tho ug ht be give n to the s trat egy a nd tac ti cs to be used to fac ilit a te the d eve lo pm ent o f such act iviti es a t the na ti o na l leve l. th e loca l leve l, a nd within pa rti c ul a r in stituti o ns. Beca use o f the di ve rs it y o f th e o rga ni za ti o na l models to be fo und a mo ng the hea lth ca re d eli ve ry sys tems o f Euro pe, no s in gle a pp roac h to the int roductio n o f qua lit y ass ura nce ac ti viti es sho uld be proposed. Ra the r, eac h co untry must move fo rwa rd g rad ua ll y, recogni zing the po liti ca l a nd p rofess io na l se nsiti viti es invo lved in eva lua ting hea lth ca re q ua lit y a nd ma kin g reco mmenda tio ns fo r c ha nge . Consider financial and legal incentives and disincentives As pa rt of thi s g radua l p rocess, it must be recogni zed tha t a m o ng ma ny p ro fess io na ls there is a fea r tha t a n ex pli cit de finiti o n o f sta nda rds fo r hea lth se rvi ces may lea d to litiga ti o n if they a re no t met. T he ex peri ence in Europe to d a te has no t , ho weve r, a pp roac hed tha t o f the Unit ed Sta tes in thi s rega rd . Furthe r , the diffe re nt a pp roac hes to fin a nc ing hea lth se rvices mean that the ro le o f fin a ncia l ince nti ves will vary fr o m co untr y to co un- try. This, the n, requires tha t the spec ifi cs o f the fin a ncing sys te m sho uld a lso be ta ken into acco unt in a ny a pproac h to the deve lo pment o f fin a ncia l incentives fo r qua lit y ass ura nce ac ti viti es. Develop public support For man y health profess io nal s, th ere is c urrentl y littl e rewa rd in th e ac ti ve pursuit of quality a ssura nce activiti es. F o r thi s reaso n, it may be impo rta nt to mobilize external pressure fr o m consumers o r go ve rnments o r to identify other approaches to internal mo tivati o n, in o rder to stimula te practi- ti o ners to beco me actively invo lved in qua lit y a ssurance activiti es . It must 7 be recognized, however, that there are risk s inherent in moving quality assurance out of the professional arena and into the political arena. Specifically , introducing the elements of government and consumer pressure may result in a substan ti al loss of profess ional autonomy and in the development of so lutions to qualit y problem s that may not be con- sistent with the expectations o r desires of professio nal groups. Legislati o n to stimulate the involvement of physicians or other health practitioners in quality assurance may have the unplanned o pposite effect of decreasing their willingness to participate in these activi ti es in a mean- ingful fashion. This has bee n the experience in the United States with the Professional Standards Review Organisa ti o n's progra mme. Conversely, however , legislative effo rt s have, in so me instan ces, stimulated initiall y reluctant hea lth professio na ls to become involved, leading to ex tremely productive quality ass urance ac ti vity. Stimulate professional curiosity In the professional arena, o ne of the mos t valuab le strategies to in vo lve hea lth ca re practitioners in effective qualit y assura nce ac ti vities is to show them the differences in performance and in patient care results o r ou t- comes. For exa mpl e, so me of the differences in practice patterns identified through the Bava ri an Perinatal Project (5) have stimulated the curios ity of the practiti oners involved to learn more abou t why th ose differences occ ur and what is the impac t of practice differences o n the o utcome of pa tient ca re. For thi s reason , data syste ms may be useful in demonstrating such differences, to th e ex tent tha t the y a ll ow the presenta ti o n of prac titi o ner- specific o r inst ituti o n-specific data o n process or o utcome. Train students Another important strategy in the profess iona l realm is to teach the specifics of quality assurance methods and the responsibility of health professionals for qualit y assurance at every level of their educat ion. There is a great need for effective educatio na l progra mmes to be developed for medical students, nursing students, and students of the va ri o us other health di sc iplines, a nd to include the phil osoph y, knowledge, and sk ill s of quality assurance activities. In a dditio n, these students shou ld be encour- aged ea rl y in their educatio nal development to participate in the delivery of care a nd in the joint eva lua ti o n of their own performa nce. Since pro- fessional educa tio n consists in large part ofa process of role modelling , it will be critical for the educa ti o nal instituti o ns themselves to begin to participate actively in qua lit y ass urance so that students in tra ining can see the importance of these ac tiviti es to th e practitioners o n whom they model themselves . 8 Develop supporting materials To support these efforts, as well as to stimulate the further development of expertise in quality assurance methods among practising health care pro- fessionals, publications and other materials on quality assurance need to be developed in each of the Member States. Such publications should be developed for at least four types of audience, each of which requires different types of information. For the public, informational and pro- motional materials need to be developed to improve their understanding of the need for quality assurance, its potential and its limitations. For health policy-makers and financiers, this information should be expanded with additional material on the social motives behind quality assurance and its role as a means of improving the cost-effectivene s of health services. Health professionals will require materials to stimulate their professional curios ity and to develop positive attitudes towards quality assurance, as we ll as more technical materials on specific methods for identifying prob- lems in the quality of care, analysing them and solving them. Finally, educators and students will require somewhat different materials, in- cluding guidance on the integration of teaching of quality assurance skills and attitudes into the curricula of various health professional education programmes. Develop support among institutional administrators Institutional administrators can play an important role in the stimu lation of quality assurance activities by placing a high priority on such efforts in their interna l budgeting. The allocation of funds to quality assurance programmes highlights their importance to the institution, and can pro- vide a strong incentive to professionals to become actively involved . In add ition, it must be recognized that quality assurance in institutions is an importa nt managerial process that can assist line department managers in identifying and resolving problems in the process of patient ca re. In this perspective, it may be seen that institutional administrators can play an important role in stimulating the development of other effective quality ass urance activities. Towards this end , effective information systems and information management within institu tions are a lso of considerable im- portance. Such information systems must be planned to include the capa- bility of developing quality ass urance data and reproducing these data as reports which are of maximum utility in the quality assurance process. Consider development of legislation Some countries may wish to consider the possibility of legislation to stim ulate both quality assurance activities and the evaluation of specific 9 health services programmes. In addition to authorizing legislation, it is critica l that adequate financial support be provided for quality assurance act ivities. The designation of a specific proportion of the national health se rvices budget to eva luative or quality ass urance activities is also a strategy worth considering. In the development of such a national strategy, how- ever, it will be important to emphasize the limitations of quality assurance at its current state of development. Over the sho rt term suc h activities a re not likely to improve the ge nera l state of health of the population, to reduce health care costs, or to produce major changes in the health care system. They can, however, result in substantial local changes in patterns of care with resultant favourable impacts on both the process of health care and its results. Over the longer term, these apparently small changes may result in substantial health and econom ic benefits. Regardless of the approach taken towards implementation of quality assurance activities, both the ethical and legal responsibi lity for the quality of serv ices continues to rest primarily with the owners or operators of health care institutions. Whether these owners or operators are private or public entiti es, they must assume the responsibility of assuring their pa- tients that the serv ices they provide meet acceptable standards of qua li ty. For this reason , an appropriate strategy for implementation could be an external system of review and evaluation in the public sector, superimposed on internal systems of review and evaluation , that are professionally o rganized and run within each health care institution or organization. Such an approach wou ld meet the twin objectives of professional accept- ability and public accountability. WHAT ACTIVITIES SHOULD BE INCLUDED IN A NATIONAL QUALITY ASSURANCE PROGRAMME? As to specific act ivities that should be included in actua l quality assurance programmes, the consensus seems to be that a pluralistic approach is essential. The current state of the art of quality assurance is such that no single approach can be recommended for all types of faci lit y or a ll types of health care delivery system. In many instances , the selection ofa particu- lar method will depend on the political environment, the level of oper- ation and complexity of the institution or organization, the sophistication of the health care professionals involved in the quality assurance process, and a variety of other environmental factors. It is possible , however, to identify a set of important characteristics of any particula r method or activity included in an operat ional quality assurance programme. In any 10 such program me. the presence of three components o f pro blem-so lving (monitoring. assess ment and improvement ) ,,·ill be cri ti ca l. Monitoring of care The fir st of t hese is a sys tem fort he continu o us monitoring of patient care so as to identi fy po tential problems tha t require in terve ntio n . A variety of a lternative methods for identifying such problems has been di scussed in the literature (6) . These alternative approaches to monitoring ma y be class ifi ed into five generic types as follows. Variation from the norm Approaches usin g thi s method a re based on th e assumption that care tha t depa rt s from the norm (mean) is different a nd ma y be indicative of a poss ib le prob lem in qua lit y. It must be emp hasized , however , tha t thi s method does no t take account of the fact tha t the norm may represe nt either suboptima l o r superio r ca re, nor does it allow fo r the possibility tha t departures from the no rm may in fact be better than care tha t is normative. For thi s reaso n. g rea t ca re is required in the interpretati on o f statistica l in fo rmatio n. Criteria-referenced screening This me thod o f identifying problems bases the defi ni tio n of po tential pro blems o n a departure fro m exp li cit definitions of desired processes o r o utcomes of care. Such exp li ci t definitions or criteria a rc deve lo ped by pee r professionals in advance a nd the actua l care provided is then co mpared with these exp li ci t cri teri a. Departures from crit eria are identified as po tenti a l p rob lems req uiring further assessmen t and poss ible int erventi on. Mu/tifactorial indices This rather co mplex meth od invo lves the development of indices o f qua lity. which may combine bo th norma ti ve a nd crit eria-referenced in fo rm ation. While there is so me available literature o n the devel o pment o f multi- factorial indices o f quality , th e meth od is complex a nd the use o f thi s approach in o pera tio na l programmes, as o pposed to research p ro- gra mm es, has been quit e limited . Small group methods Sin ce the hea lth profess io na ls in vo lved in the provisio n o f health services a re gene ra ll y in the best po ition to be able to ident ify problems in patien t 11 care, the use of struct ured sma ll groups to elicit such informati on a nd determine priorities fo r intervention can be very va luable . Such methods as the no minal gro up technique (6) have proved va luabl e in identifying problems in the qualit y of ca re even in the absence of either no rmative or criteria-referenced d a ta. Surveys Formal surveys of hea lth workers, including physicia ns, nurses and o ther hea lth profess io nals, have proved to be effective mechanisms for identify- ing quality of care issues. In addition, surveys of patient s can be very valuable in identifying problems both in technical qua lit y and in patient sa ti sfactio n. In a ny a pproac h to problem identifi catio n, it will be importa nt for the subjects of qua lit y ass ura nce activiti es to be iss ues in which qualitative improvement is likely. Further, subj ects that a re highl y preva lent, tha t require high resources, a nd in which there is good professio na l consensus abo ut the approp ri a te process or o ut come tend to be most productive as the focus of quality assurance activities . Assessment of problems The second key co mpo nent of problem-solving tha t must be included in a national quality ass ura nce p rogra mm e is the assessment of actua l o r suspected prob lems identified th ro ugh the monit o rin g p rocess. Ma ny assessme nt met hods have been deve loped and a rather la rge lit era ture has grown up expla inin g them (7) . They share, however, a common depen- dence o n the use of ex plicitly written criteria to defin e acce ptable or expected performa nce a nd to se rve as a po int o f reference in co mparing the actual care provided. Assessment meth ods may be based o n a va riety of da ta sou rces, as well. So me of these data sources will be patient reco rds, but increas ingly such methods as direct observa ti o n, interviews and co mputerized pa ti ent in fo r- mation sys tems are becoming of va lue in conducting assess men t studies. Regardless of the method se lected , o r the data sources employed, the result o f the assessment must be a clear unders tanding o f whether or not there is in fact a probl em a nd what the causes o f th at problem are. Thi s then ca n serve as the foc us for the third essent ial fun cti o n, improvement in the q ua lit y of services. Thi s third co mpo nent is di scussed in greater detail o n pp . 16- 19. 12 LHel of operation It may be l)f rnluc in dc,·cloping the specific acti, ·itics to be included in an ,ipcra ti onal quality assurance programme tn cnnsidcr a three-dimensional matrix defining the functi o m. content. and Ic,·el nf npcra tinn ,1 f quality assurance 11·i1hin th e health care s~stcm. Such a matri, defines -18 discrete cells. which any countr~ ·s health care deli, ·cr~ ,~stem muq be cnnccrncd 11·ith in dc,-cloping cffecti,·~· qualit~ ;1ss ura11 cc acti,·itic,. A, depicted in Fig. I, the functions of quality assurance ( nwnit oring. a"cssmcnt and improvement) arc first superimposed 011 the four content areas (pro- fessional performance. res o urce use. risk . and patient satisl'action). lach of t hesc eel Is may then be seen as c .xis tin g at one n f the four Ic,-cls o f organization of the health care dcli, ·cry system (self-care. primary care. secondary care and tcrtiar~ care). In making an i11\'cnt o r~ o f the ap- proaches to be taken in a nati o nal health care system for imprnving health care quality. it 11·ill be critical for each of the 48 ce lls tu be carefully rnnsidercd . and for appropriate activities to be dc,-cl o pcd in each. For instance . this matrix stimu la tes one to ask questi o n, such as: 11·hat ac- tiviti es in a nati onal health system ha,-e been de,-cloped for monitoring professional performance at the secondary care lc\'cl: or 11·hat acti, ·itics nr mechanisms exist for imprO\·ing the use of resources at the tertiary care lc,·el'1 Questions of such a specific nature arc more readily addressed within the context of the social and po litical en,·ironment in a na ti o nal health care sys tem than are mo re global iss ues s uch as ho w quality i, maintained. Acco rdingly. such a matrix may be of great value in facilitat ing th e development of a spec ifi c mixture o f quality ass urance activities in a national health programme. In addition to the various opera tiona l activities defined by the matrix in Fig. I, in order for a national quality assura nce programme to be success- ful three o ther categories of activity arc essential : educa ti on. research and development, a nd informatio n systems. Education of health professionals One of the major difficulties that has handicapped the de ve lopment and dissemination o f qualit y assurance programmes has been the lack of ed ucatio n among health care professionals and hea lth care students in the na ture , objec tives, and methods of health care quality assurance. U nless thi s deficiency is remedied , effo rt s to develop quality assurance pro- gra mmes will continue to be ha ndicapped. Accordingl y, a key component of any national effort to devel o p effective quality a ss urance activities will be the d evelopment of curriculum and training activities for health care students a t a ll levels of their education, as well as the development of continuing educa ti on programmes in quality assurance for practitioners cur rentl y providing services. 13 1- z w 1- z 8 Fig . 1. Three-dimensional matrix illustrating the components of an operational national quality assurance system Professional performance Resource use Risk Secondary care Patient satisfaction 0~ Primary care ~"' ~ 0'1/" 0~ o'< ,., .... ,.,~ 'v FUNCTIONS 14 In addition, educational strategies for the public and for political figures in every country will be the key to developing the type of public and government support necessary for quality assurance initiatives to survive. Currently, the public in most countries has unrealistic expectations of the capability of medical care to cure illness. For quality assurance initiatives to begin to have some impact , it will be essential for the public to gain a better understanding of the limitations of medical care, of their responsi- bilities for their own health , and of the need for continuous evaluation and improvement in the services provided by health care institutions as a mechanism for maximizing efficacy and efficiency. Similarly, key political figures in every country must better understand the importance of quality assurance and evaluation activities if the resources necessary for these activities are to be forthcoming. Research and development in quality assurance In a similar fashion, it will be critical that resources for research and development programmes on quality assurance be routinely included in the health budgets of every country. The designation of a specific per- centage of the national health budget for research and development in evaluation and quality control is a reasonable approach towards im- proving the quality of services and developing more effective programmes for their delivery in a particular sociopolitical environment. If improve- ments are, indeed, to be made in the quality of health services, it will be essential for adequate research to be conducted into the development of more efficient and effective mechanisms than are currently available for quality assurance. While some of the methods that have been used to date have been effective, others have been relatively ineffective. It is only through careful research and evaluation into such complex issues that better means of identifying and resolving problems in the quality of care may be developed. Information systems development Finally, as an important component of the development of quality assur- ance systems, it will be critical for countries to develop information sys- tems that provide the kinds of data that are critical to quality assurance. Unfortunately, most information systems that have been developed for use in health care organizations or systems are not sufficiently specific or comprehensive to be of value in quality assurance . Many of them are oriented strictly towards productivity or financial information, and omit many of the clinical data that are of key importance in quality assurance. Further, even among those that do include clinical information, there are often high rates of error in data collection, and difficulties in linking 15 patient-specific data across levels of care. If these problems can be resolved, it will greatly facilitate the use of health information systems as a quality assurance tool, as well as providing a tremendously valuable resource for research into more effective means of health care delivery. HOW CAN QUALITY OF SERVICES, IF FOUND DEFECTIVE, BE IMPROVED? The third and final functional component of a national quality assurance system is the improvement of health care. If this component is missing, or underdeveloped, then energy and resources devoted to the first two func- tions will have been wasted. Unfortunately, improvement in services is often the most difficult of these three functions to perform. Because health care is a complex undertaking, often conducted in institutions of substan- tial organizational complexity, by autonomous professionals, and involv- ing scientifically complex activities, it may be exceedingly difficult to produce change. Nonetheless, change can be effected through the use of principles of individual and o rganizational behaviour. One of the major barriers, at present, to effect ive improvement is the lack of an attitude among health professionals and health care organizations that is receptive to the in- itiatives for change that grow out of quality assurance programmes. This problem has been discussed earlier (pp. 3 and 6-7). If this problem can be effectively addressed through education at every level of the health man- power development process, it will be a major step towards improving the efficacy of a variety of quality improvement activities throughout the health care system. Consider reward systems Individual health care practitioners resist efforts to modify their be- haviour for a variety of reasons . One of the most important is related to the reward systems that operate in particular health care deli very systems. Accordingly , if efforts at improvement are to be effective, it will be essen- tial to consider the economic and other incentives in the de livery system that may influence the behaviour of practitioners. It will be futile to attempt to make changes that run contrary to economic incentives, unless there are substantial economic or political sanctions ava ilable. Since most Western European countries probably prefer not to use such sa nctions, it will be critical that economic motivations or other reward systems are identified. 16 Be aware of habit patterns In addition , it must be kept in mind that the behaviour of health care practitioners is often conditioned by a long and complex set o f behavioural st imuli that have produced a set of conditioned responses to particular clinical situations. If these habitual responses are subopt imal, they may pose particularly difficult obstacles to efforts to produce change. Most adults, however, can be motivated to change even the most complex of behaviour patterns if they can see it to be in their best interests. Health professionals, in addition, may often be motivated by discovering that a new pattern of behaviour is in the best interest of their patients. Pro- fessional altruism is an important positive force in the improvement of the quality of care and must be recognized and used wherever possible. A void punitive strategies One of the major failings in many initiatives to improve quality, however, has been the use of punitive approaches that immediately provoke defen- sive responses among practitioners. Human nature dictates that when the professional performance of an individual is attacked, he or she wi ll defend the status quo. Accordingly, it will be critical that effective mechanisms be developed for bringing to the attention of practitioners those areas in which improvements can be made, in such a way that they do not feel that it is necessary to defend their current behaviour. Experience has shown that person-to-person discussions are much more effective in this regard than are written communications, which tend to become officious and to con- note official sanction . Further information on individual strategies for change shou ld be developed through effective research programmes as part of the research and development initiatives discussed on pp. I 0-16. Use methods of organizational change Within health care organizations, initiatives for change may often be met with a variety of organizational strategies for resistance . An extensive literature on organizational change (8) can be a valuable resource in improving the efficacy of institutional quality assurance initiatives. The larger and more complex the organization , the more successful it tends to be in resisting change. Quality assurance, however , must be seen as an agent of institutional change, if it is to be effective. Accordingly, insti- tutional quality assurance programme staff will need to develop extensive ski ll s in the identification of the causes of resistance to change in organ- izations, and in strategies and tactics of organizational change. Four categories of strategy for change have been identified in the literature (9) . These include re-education, facilitation, persuasion and power. 17 Re-education Re-education is the process by which the organization and its members learn new and, hopefully , better ways of doing things . This a pproach is based on the principle that reasonable individuals will react reasonably when they are given information that allows them to conclude that change is appropriate. In this capacity, it is critical that the information be presented in a non-threatening fashion. Hence, the availability of infor- mation systems for quality assurance will be a key component. Facilitation Facilitative strategies are those that attempt to assist the organization in changing itse lf. These include a variety of methods developed by social scientists, including organizational psychologists, such as team building, conflict resolution , consensus building, and other small group methods for facilitating the process of organizational change. Persuasion Persuasion strategies will rely on the ability of a respected member of the organization , or an o utside r of influence, to stimulate consideration of a new or different approach to organizational performance. This mechanism is most effective early in the process of change and requires that other methods be available to continue to solidify the process once change has begun. Power Strategies for change based o n power are often used in o rganizations, but have severa l undesirable characteristics. Power is an external motive for change, and often produces surface compliance with initiatives fo r change, while stimulating deeper resistance to long-lasting change. Power can se rve as a successful external motivator, but must be supplanted by an- other mechanism for solidifying and internalizing the new behaviour thus created. Nonetheless , the exercise of effective power strategies for change by those who have power within the organization, or the power to affect the organization from outside, can be extremely va luable mechanisms for initiating the process of change. In the area of improvement, there is also a clear need for additional research so that more cost-effective means may be found for facilitating improvements in care. Many of these improvements may involve the very 18 nature of health services in the developed countries, parti cularl y o ur current reliance on curative medicine and sophisticated techn o logy. It may well be demonstrated tha t one of the most effective mechanisms available for quality improvement would be to stimulate greater reli a nce o n the prevention of illness a nd on the personal and individual respo nsibilit y o f the public for its own health. In any event, there will continue to be a need for effective mechanisms for identifying and solving patient care problems; accordingly, the need for quality assurance in health care will persist. CONCLUSIONS AND RECOMMENDATIONS WHO must play a leading role in facilitating the development , promotion, and implementation of effective mechanisms for quality assurance in the European Member States. Although the nature of the specific activities to be conducted by each country will vary with its social, political and professional situation, seven major principles can be enumerated to serve as guidelines for WHO and the European Member States in working towards an effective and efficient approach to quality assurance in health care. I. The methods employed must lead to the identification and resolution o f problems in the provision of healt h se rvices and to the identification of opportunities for improvement in health care, so as to have positive effects o n the physical, mental and social wellbeing of patients. 2. Quality assurance act ivities should include consideration of efficiency and risk, as well as effectiveness, in order to promote ca re that achieves optimal benefits, at minimal cost, with minim al risk of further injury or disability . 3. Consideration must be given to developing programmes that encom- pass the emotional and social aspects of health care quality, as well as the scientific and technical aspects. 4. Quality assurance activities must be integrated into the direct clinical and institutional management functions of hea lth professionals and health care institutions, rather than separated or isolated from those activities. Accordingly, quality ass urance should become an opera tio na l responsi- bility of line management personnel , both clinical and administrative, at all levels of health care. Adequate resources and support to facilitate and coordinate quality assurance activities should be provided by the admin- istration of each health care organization. 19 5. The appropriate locus of quality assurance ac ti vities extends across every o rgan iza tional level in hea lth care, from the individual interaction between patient a nd provider through instituti ona l subunit s, institutions and regions, to countries. 6. All health profess ions have a public obligat ion to participate in quality assurance activities. Because the provision of health services requires the coordinated efforts of a variety of health disciplines , evaluation and im- provement of the quality of health services should also be performed through interdisciplinary coordination of the professionals involved in care. 7. Because health care is a rapidly changing field, and health care quality assurance methods are still in a period of experimentation and develop- ment , any approach chosen for quality assurance in the Member States should mainta in the flexibility to change as the state of the art of quality assurance continues to evolve. These principles should provide important signposts for the develop- ment of quality assurance activities at the national level. In order to faci litate the further development and implementation of qualit y assur- a nce programmes consistent with these principles, the Wo rking Group made the following recommendations. I . A comprehensive plan should be developed and implemented for the co llection and dissemination of information on quality assurance methods, activities, and results in the Member States. The development of informational , motivational and technical publications on quality as- surance should be included in this plan for such audiences as the public, health policy-makers, health professionals, health services financiers , and educators . 2. Organizations of health professionals in the Member States should be encouraged to plan and implement programmes to increase the motivation of their members to be actively involved in quality assurance activities. 3. Each Member State should , as a component o f it s national health plan , defi ne the orga nizati on(s) responsible for quality assurance activities and establish mechanisms for assuring the public that those responsibilities a re met. 4. Member States should be encouraged to allocate a percentage of their financial resources for hea lth se rvices to quality assurance research , de- ve lopment , ed ucation, a nd implementation. 20 5. Educational institutions in the Member States sho uld devel o p pro- grammes for training all hea lth care students in qualit y assurance, such that the attitudes, skill s a nd knowledge necessa ry fo r effective qualit y control are developed in each individual. In addition, a ppropria te post- graduate o r continuing educatio n programmes sho uldJ!e d eve lo ped to . . J . . foster these attitudes, skill s, a nd kn owledge among pra ct1 s1ng hea lth professio nals. 6 . Where necessary and appropriate, Member States should devel op legislatio n to implement the reco mmendations o utlined a bove. The Working Group recognized tha t the principles a nd reco mmen- da ti o ns it had enumera ted we re a mbitio us. It was further recogni zed tha t effo rts to implement these recommendations must of necessity be gradual a nd tha t th e a reas of emphas is will va ry a mo ng the Membe r States. No netheless, the Wo rking Group felt that the principles and reco mmen- da ti o ns should se rve as a lo ng-ra nge framework within which WHO a nd its individua l Member States co uld work towa rds th e ultima te o bj ec ti ve of a co mprehe nsive system for quality ass ura nce as a n esse nti a l co mpo nent of the hea lth care delive ry system. The Wo rking Group co ncluded th a t as hea lth pro fess io nal s, hea lth care ins tituti o ns, gove rnments and the edu- cational system work toget her towards thi s goa l, the p ubli c they se rve will benefit fro m effec ti ve, efficient health services that maximize the oppor- tunit y for each indi vidua l to enjoy good hea lth . R EFE R ENCES I. Vuori, H.V. Quality assurance of health services. Copenhage n, WHO Regional Office for Europe, 1982 (Public Health in Europe, No. 16) . 2. Mc Lamb, J.T. & Huntley, R.R . The haza rds o f hosp ita li za ti o n. Southern medical journal, 60: 469-4 72 ( 196 7). 3. Steel, K. et al. Ia troge ni c illness o n a ge nera l medica l service a t a University H ospital. Nell' England journal of medicine, 304: 638-642 ( 1981 ). 4. Donabedian, A. The definition of quality and approaches to its assess- ment. Ann Arbor, Hea lth Administration Press, 1980. 5. Selbmann, H.K. et al. Co mpariso n of hospita ls support ing quality ass urance. Methods of information in medicine, 21: 75-80 ( 1982). 6. Jessee, W.F. Identifying health care quality problems: a practical manual. C hapel Hill , Departme nt o f Hea lth Po li cy a nd Admini stra ti o n, 1982 (HPAA Monogra ph , No. 8). 21 7. Vanagunas, A. Quality assessment: alternate approaches. Quality re- view bulletin, 5(2): 7-10 ( 1979). 8. Jessee, W.F. Approaches to improving the quality of health care: organizational change. Quality review bulletin, 7(7): 13-18 ( 1981 ). 9. Zaltman, G. & Duncan, R. Strategies for planned change. New York, John Wiley, 1977. 22 Annex I PARTICIPANTS Temporary advisers Mr L. Bohigas, Chief, Department of Health Care Planning, Catalan Regional Health Authority , Department of Health and Social Assistance, Directorate-General of Health , Barcelona, Spain (Chairman) Dr J . Heyr_man, Minderbroedstraat 17, Leuven, Belgium Dr W.F. Jessee, Associate Professor of Health Policy and Adminis- tration , The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA (Rapporteur) Dr D. Jolly, Director, Programme of Public Assistance in Paris, France Dr A. Net i Castel, Medical Director, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain Mrs R.M. Pelkonen, Kopolantie, Suonenjoki, Finland Dr F. Perraro, Emergency Internal Medicine Department, General Hospital, Udine, Italy Dr E. Reerink, Executive Director, National Institute for Quality Assurance in Hospitals, Utrecht, Netherlands Professor P. Reizenstein, Department of Haematology, Karolinska Institute, Stockholm, Sweden Dr P. de Schouwer, Secretary-General, Ministry of Public Health and Family Affairs, Division of International Relations, Brussels, Belgium Professor H.K. Selbmann, Ludwig-Maximilians University, Institute for Medical Data Processing, Department of Statistics and Bio- mathematics, Munich, Federal Republic of Germany 23 Dr M.G. Sheldon, Department of Community Health, University of Nottingham Medical School, United Kingdom Professor M. Simo nic , Zelemgak 43 , Zagreb, Yugoslavia Dr R. Sunol , Quality Assurance Coordinator, Hospital de la Santa Creu i Sant Pau , Barcelona, Spain Mr J. Wyn Owen , Director, Health Services Development Group, United Medical Enterprises Ltd ., London, United Kingdom Representatives of other organizations International Council of Nurses Dr J . Nadal , Executive Adviser for Teaching and Research, Ministry of Health and Consumer Affairs , Madrid, Spain Ms M.T. Piulachs, Director of the Department of Teaching and Re- search, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain Observers Dr J .L. Ausin, Health Inspection Department, Barcelona, Spain Dr J .L. Lancho , Sub-Director General of Health Evaluation, Ministry of Health and Consumer Affairs , Madrid, Spain Mrs C. Netzel , Director of Nursing, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain Dr H. Pardell, Head oflnternal Medicine Department, Hospital "Creu Roja", Barcelona, Spain Dr J. Ramos Sarasa, Sub-Director of Functional Arrangements, Min- istry of Health and Consumer Affairs , Madrid, Spain Mrs M. Shanahan , Director. Department of Publications, Joint Com- mission on Accreditation of Hospitals, Chicago, IL, USA WHO Regional Office for Europe Dr H. Vuori , Regional Officer for Primary Health Care 24 RESUME Introduction Les quinze membres du groupe de travail sur !es principes de !'assurance de la qualite et !es quatre observateurs presents etaient notamment des medecins, des fonctionnaires d 'administration sanitaire, des enseignants en medecine et des enseignants en sante publique representant des domaines professionnels divers (soins infirmiers , sciences economiques , biostatistiques et administra- tion hospitaliere) . Ils venaient des pays suivants : Republique federale d'Alle- magne, Belgique , Espagne , Etats-Unis , Finlande, France , Halie, Pays-Bas, Royaume-Uni , Suede et Yougoslavie . Partant de l'hypothese selon laquelle I'assurance de la qualite est un concept nouveau mais qu 'iJ est souhaitable de mettre en reuvre dans les Etats Membres de la Region europeenne de !'OMS, le groupe de travail devait suggerer comment presenter ce concept aux autorites sanitaires, aux professionnels de la sante, a la communaute scientifique et aux consomma- teurs de services de sante. II a essaye d'analyser et d'apporter une repon se aux questions suivantes : pourquoi !'assurance de la qualite est-elle necessaire? quels sont ses objectifs ? quel est le meilleur moyen de l'introduire aux niveaux national et local ? quelles activites doit comporter un programme d'assurance de la qualite ? comment ameliorer la qualite des services dans le cas ou ceux- ci sont consideres non satisfaisants ? Information de base Bien que ni I 'Assemblee mondiale de la sante ni le Comite regional n'aient adopte de resolutions mentionnant explic itement !'assurance de la qualite , l'origine de ce concept apparaft clairement : la qualite figure implicitement dans la Constitution de l'OMS , dans les sixieme et septieme programmes generaux de travail et dans de nombreuses recommandations concernant la fixation de normes et de criteres ainsi que l'evaluation des services de sante . II est egalement clair que l'interet pour !'assurance de la qualite est de plus en plus net dans Jes Eta ts Membres. 25 L'interet que !'OMS porte actuellement a cette question decoule naturellement et logiquement de ses activites anterieures qui ont reflete ce mandat implicite. Si !'on rcgarde les rapports et recommandations des groupes de travail reunis par le Bureau regional , on s'apen;oit en effet que le concept de !'assurance de la qua!ite apparait de plus en plus frequemment au cours des discussions sur !'evaluation des services de sante et !'utilisation efficace des ressources disponibles . Themes de discussions et conclusions Le groupe a essaye de definir plus clairement Jes caracteristiques souhaitables des programmes d'assurance de la qualite dont la necessite ne fait plus de doute. Comme dans le cas des procedes industriels. il est essentiel d'integrer a tout systeme de prestations des mecanismes efficaces d'evaluation et d'ame- lioration des soins de sante . Devant la complexite et la technicite croissantes des systemes de services de sante des pays developpes d'Europe et d'autres regions du monde, les anciennes methodes (telles que la certification du personnel et d'institut ions) ne permettent plus de contr61er de maniere satis- faisante la qualite des soins . Il faut done elaborer de nouveaux mecanismes et methodes pour garantir la responsabilite des professionnels de la sante et des institutions de soins a l'egard du public qu'il s servent . Le groupe de travail a conclu que !'OMS devrait montrer la voie a suivre pour faciliter la conception , la promotion et !'application de mecanismes efficaces d'assurance de la qualite dans Jes Etats Membres de la Region euro- peenne . Bien que la nature des differentes activites que realiseront les divers Etats sera fonction du contexte social, politique et professionnel , le groupe de travail a fixe sept grands principes directeurs qui devront permettre a !'OMS et aux Etats Membres de la Region europeenne d'aborder avec effica- cite et efficience la mise en place d'activites d'assurance de la qualite des soins de san te . 1. Les me th odes u tilisees doivent con du ire a !'identification et a la solu- tion des problemes poses par la fourniture de services de sante et a !'identifi- cation des possibilites d'amelioration des soins pour accroitre le bien-etre physique , mental et social des patients. 2 . L'assurance de la qualite ne doit pas etre seulement efficiente, mais egalement efficace et tenir compte des risques , c'est-a-dire deboucher sur des soins d'une qualite optimale , pour un c011t minimum et qui reduisent au minimum les risques d'aggravation des traumatismes ou des handicaps. 3 . II faut che rcher a elaborer des programmes qui tiennent compte, outre des aspects scientifiques et techniques, des aspects sociaux et affectifs de la qualite des soins de sante . 26 4. Les activites d'assurance de la qualite ne doivent pas etre isolees ou separees des fonctions cliniques et de gestion des professionnels et des insti- tutions de sante mais y etre directement integrees. L'assurance de la qualite doit done dependre du personnel charge de la gestion des soins comme de !'administration, a tous !es niveaux , y compris au niveau des soins de sante primaires et des institutions. Le responsable de chaque organisation presta- taire de soins de sante devrait fournir Jes ressources et l'appui necessaires pour faciliter et coordonner !es activites d'assurance de la qualite . 5. L'assurance de la qualite doit englober tous !es niveaux des soins de sante, depuis la relation entre le patient individuel et le prestataire de soins jusqu'au niveau de !'institution, de la region et de la nation. 6 . Toutes Jes professions de sante ont !'obligation, vis-a-vis du public, de participer aux activites d'assurance de la qualite. La fourniture de services de sante supposant Jes efforts coordonnes de diverses professions de sante, !'eva- luation et !'amelioration de la qualite de ces services doivent egalement etre le resultat d'une cooperation interdisciplinaire des professionnels concernes. 7. Etant donne que Jes soins de sante sont un domaine en evolution rapide et que !es methodes d'assurance de la qualite des soins sont encore au stade de !'experimentation et du developpement , toute approche choisie par !es Etats Membres doit etre suffisamment souple pour pouvoir etre modifiee et amelioree . Recommandations Afin de faciliter !'elaboration et !'application de programmes d'assurance de la qualite conformes a ces principes, le groupe de travail a formule !es recommandations suivantes : 1. L'OMS devrait elaborer et mettre en reuvre un plan general de col!ecte et de diffusion d'informations sur les activites d'assurance de la qualite, Jes methodes utilisees et !es resultats obtenus par Jes Etats Membres. Ce plan devrait egalement inclure la preparation de publications techniques, d'information et d'encouragement a !'application de !'assurance de la qualite et destinees aux responsables de la sante publique , aux professionnels de la sante, aux financiers des services de sante et aux enseignants en soins de sante . 2. Les organisations professionnelles sanitaires desEtats Membres devraient etre encouragees a concevoir et a mettre en reuvre des programmes destines a motiver davantage leurs membres a prendre une part active a !'assurance de la qualite. 27 3 . Chaque Etat Membre devrait , dans le cadre de son plan sanitaire natio- nal, definir la ou Jes organisations responsables des activites d'as urance de la qualite et mettre en place des mecanismes a fin de montrer au public qu 'il s'est acquitte de ses responsabilites. 4. Il faudrait encourager Jes Etats Membres a affecter une part de leurs ressources financieres a la recherche et au developpement de services d'assu- rance de la qualite , a )'application de ces services et a leur enseignement. 5 . Les centres d'enseignement des Etats Membres devraient definir des programmes de fonna tion des etudiants de tou tes professions sanitaires a !'assurance de la qualite afin que chacun ait Jes attitudes , Jes competences et Jes connaissances necessaires a un contr6le efficace de la qualite. De plus , ii faudrait mettre en place des programmes appropries de formation pennanente pour pennettre aux professionnels de la sante deja en activite d'acquerir ces attitudes , competences et connaissances. 6. Si cela est a la fois necessaire et possible, Jes Etats Membres devraient elaborer une legislation pour mettre en reuvre Jes recommandations exposees ci-dessus. 28 ZUSAMMENF ASSUNG Einleitung Die fonfzehn Teilnehmer und vier Beobachter der obigen Arbeitsgruppe um- faBten mehrere Arzte, Beamte des Gesundheitswesens sowie Lehrkrafte aus dem medizinischen Bereich und dem offentlichen Gesundheitswesen; an Fachbereichen waren vertreten : Krankenpflege, Wirtschaft , Biostatistik und Krankenhausverwaltung. Die Teilnehmer kamen aus den Llndem Belgien, Bundesrepublik Deutschland, Finnland, Frankreich, ltalien, Jugoslawien , Nie- derlande, Schweden, Spanien, USA und Vereinigtes Konigreich. Ausgehend von der Annahrne, daB Qualitatssicherung ein neues, anstre- benswertes Konzept der europaischen Mitgliedstaaten der WGO ist, wurde die Arbeitsgruppe beauftragt, eine Strategie for die Einfohrung dieser Disziplin bei Gesundheitsbehorden, Gesundheitsfachkraften, in wissenschaftlichen Kreisen und bei den Empfangem von Gesundheitsleistungen zu entwerfen. Die Arbeitsgruppe bemtihte sich um die Untersuchung und Beantwortung nachstehender Fragen: Warum benotigt man die Qualitatssicherung? Welches sind ihre Ziele? Wie kann sie am besten auf nationaler und lokaler Ebene eingefohrt werden? Welche Tatigkeiten soil ein reelles Qualitatssicherungsprogramm um- fassen? Wie kann die Qualitat der Dienstleistungen, falls sie nicht zufrieden- stellend ist, verbessert werden? Allgemeines Obwohl die Weltgesundheitsversammlung und das Regionalkomitee keine Re- solutionen iiber die Qualitatssicherung als solche verabschiedet haben, liegt trotzdem eine klare Aufgabenstellung vor: Die Forderung nach Qualitat ist implizit in der WGO-Verfassung, dem Sechsten und Siebenten Allgemeinen Arbeitsprogramm und in den zahlreichen Empfehlungen enthalten, die sich auf die Erstellung von Normen und Standards und die Bewertung der gesund- heitlichen Dienstleistungen beziehen. AuBerdem nimmt offensichtlich das In- teresse der Mitgliedstaaten an der Qualitlitssicherung zu. 29 Das gegenwartige Engagement der WGO bezUglich der Qualitiitssicherung ergibt sich automatisch aus frUheren Tatigkeiten, die implizit die genannte Aufgabenstellung enthalten. Bei Durchsicht der Berichte und Empfehlungen im Zusammenhang mit Arbeitsgruppentagungen , die vom Regionalburo veran- staltet worden sind, stoBt man bei Behandlung der Evaluierung der Gesund- heitsleistungen und bei der Besprechung einer effektiven Nutzung der vorhan- denen Ressourcen in zunehmendem MaBe auf Fragen der Qualitiit. Besprechungsthemen und Schluf.)folgerungen Die Arbeitsgruppe bemUhte sich um eine klarere Festlegung der Merkmale, die ein Qualitatssicherungsprograrnm haben sollte. DaB Qualitiitssicherung beno- tigt wird , steht fest . Wie bei industriellen Prozessen werden auch bei der Lei- stungserbringung im Gesundheitssektor effektive Mechanismen zur Beurtei- lung und Verbesserung der Gesundheitsversorgung absolut benotigt. In dem MaBe, wie die Komplexitat und technologische Verfeinerung des Gesund- heitsdienstes in den lndustrielandem Europas und anderen Bereichen der Welt zunehmen, werden frUhere Praktiken der Qualitatskontrolle (z.B. Zulassungs- bestimmungen for Personal und Institutionen) Uberholt und konnen dem Zweck der Qualitatskontrolle nicht mehr gerecht werden. Es mUssen also neue Methoden und Verfahren der Qualitatssicherung eingeftihrt werden, damit die Gesundheitsberufe und die Institutionen der Gesundheitsversorgung ihre Pflicht gegenUber der Offentlichkeit erflillen konnen. Die Arbeitsgruppe kam zu dem Ergebnis, daB die WGO hinsichtlich der Ausarbeitung, Forderung und Umsetzung effektiver Mechanismen der Qua- litatssicherung in den europaischen Mitgliedstaaten eine ftihrende Rolle Uber- nehmen solle. Auch wenn die spezifischen Aktivitaten jedes Landes entspre- chend den sozialen, politischen und beruflichen Gegebenheiten von denen anderer Lander abweichen werden, sollten nach Meinung der Arbeitsgruppe hinsichtlich eines effektiven und effizienten Ansatzes for die Qualitatssiche- rung for die WGO und ihre europaischen Mitgliedstaaten sieben Grundsatze gel ten: 1. Die anzuwendenden Methoden mUssen bewirken, daB die Probleme beim Leistungsangebot identifiziert und gelost und die Moglichkeiten einer Verbes- serung der Gesundheitsversorgung erkannt werden ; auf diese Weise wird das korperliche, geistig-psychische und soziale Befinden der Patienten positiv beeinfluBt. 2. Bei der Anwendung der Qualitatssicherung mUssen auch Effizienz, Risi- ken und Effektivitiit beriicksichtigt werden, darnit bei minimalen Kosten und der geringstmoglichen Gefahr weiterer Gesundheitsschaden oder einer Behin- derung ein optimaler Nutzen erzielt wird. 30 3. Bei der Ausarbeitung der Programme ist darauf zu achten, daB auch die emotionellen und sozialen Aspekte der Versorgungsqualitat sowie die wissen- schaftlich-technischen Aspekte mit einbezogen werden. 4. Die Quaiitatssicherung muB in die direkten klinischen und institutionel- len Managementfunktionen der Gesundheitsfachkrafte und Versorgungsein- richtungen eingebaut und darf nicht von ihnen abgetrennt werden. Dement- sprechend sollte die Qualitatssicherung in den betrieblichen Verantwor- tungsbereich des klinischen und administrativen Managementpersonals auf alien Stufen der Gesundheitsversorgung fallen - dies sowohl in der Primarver- sorgung als auch im Bereich der institutionellen Betreuung. Die Verwaltung jeder Gesundheitsversorgungsstelle sollte for ausreichende Ressourcen sorgen und die Tatigkeiten der Qualitatssicherung erleichtern bzw. koordinieren. 5. Der Anwendungsbereich der Qualitatssicherung erstreckt sich auf alle or- ganisatorischen Ebenen des Versorgungswesens und erfaBt den gesarnten Bereich von der Wechselbeziehung zwischen Einzelpatient und Leistungser- bringer bis hin zu institutionellen Teilbereichen, Institutionen, Regionen und Staatsebene. 6. Alie Gesundheitsprofessionen unterliegen einer offentlichen Verpflich- tung zur Anwendung von QuaiitatssicherungsmaBstaben. Da die Erbringung von Gesundheitsversorgungsleistungen den konzertierten Einsatz verschiede- ner Gesundheitsdisziplinen voraussetzt, sollte auch die Evaluierung und Qua- litatssteigerung hinsichtlich der Gesundheitsgi.iter im Rahmen einer interdis- ziplinaren Zusammenarbeit der entsprechenden Fachbereiche erfolgen. 7. Da die Gesundheitsversorgung einer laufenden Anderung unterliegt und sich die Quaiitatssicherungsmethoden noch im Stadium der Entwicklung be- finden, sollte man beim Einschlagen eines bestimmten Weges zur Durchfoh- rung der Qualitatssicherung in einem Mitg]iedstaat eine gewisse Flexibilitat bewahren, darnit man sich dem jeweiligen Entwicklungsstand dieses Fach- gebiets anpassen kann. Empfehlungen Um die Ausarbeitung und Umsetzung von Qualitatssicherungsprogrammen gemaf!. diesen Prinzipien zu ermoglichen, empfiehlt die Arbeitsgruppe fol- gendes: 1. Die WGO sollte einen umfassenden Plan zur Erfassung und Verbreitung von Informationen iiber Methoden, Tatigkeiten und Ergebnisse der Qualitats- sicherung in den Mitgliedstaaten ausarbeiten und verwirklichen. Der Plan soll- te auch die Erstellung von informatorischen, motivierenden und technischen Schriften beriicksichtigen, die an Entscheidungstrager des Gesundheitswesens, Gesundheitsfachk.rafte, Stellen der Gesundheitsverwaltung und Lehrkrafte zu verteilen sind. 31 2. Die Verbande der Gesundheitsfachkrafte in den Mitgliedstaaten sollten ihre Mitglieder zur Mitarbeit an Qualitatssicherungsprojekten anregen. 3. Jeder Mitgliedstaat sollte im Rahmen seines nationalen Gesundheitsplans die Stelle ( oder Stellen) festlegen, die fur die Qualitiitssicherung zustandig ist (sind) und Verfahren entwickeln, damit die C>ffentlichkeit iiberzeugt sein kann, daB man seiner Verantwortung nachgekomrnen ist. 4 . Die Mitgliedstaaten sollten dazu angehalten werden, einen gewissen Teil des Gesundheitshaushalts for die Forschung, Entwicklung, Unterweisung und praktische Durchfohrung der Qualitiitssicherung abzuzweigen. 5. Die Lehranstalten der einzelnen Lander sollten in ihren Ausbildungsplan auch die Qualitatssicherung aufnehrnen, damit der einzelne sich die richtige Haltung, das entsprechende Konnen und Wissen aneignen kann, um eine ef- fektive Qualitatssicherung zu ermoglichen. Um den praktizierenden Gesund- heitsfachkraften die entsprechende Haltung, das Konnen und Wissen beizu- bringen, sollte man auBerdem nachuniversitare Kurse und Fortbildungspro- gramme einrichten. 6. Gegebenenfalls sollten die Mitgliedstaaten gesetzliche Vorschriften zur Verwirklichung der obigen Empfehlungen erlassen. 32 PE3DME BBe.IleHHe B COBe!llaIDrn Pa(X)t1eH rpyrnn,i no npHHUH11aM oOecnet1eHHR Ka'lecTBa rtpHHRIDI yt1aCTHe 15 yt{aCTHHJ<OB H 4 HaOnio,IlaTenR c rtJX)(t,eccHOHa.llbHOO OPHeHTauHeH B oOnaCTH cec'I'PHHCKOro .nena, 3KOHOMHKH, OHOCTaTHCTHKH H (X}JlbtnNHOro oOc.nymiBaHHR. Cpe.nH HHX OYJ1H Bpa'IH, paOo'I'HHKH o¢HUHa.JlbHl>IX opraHOB 3.IlpaBOOXpa- HeHHR, npertO,llaBaTeJIH Me.IlHUHHCKHX Hay}( H oO!neCTBeHHoro 3,IlpaBOOXpaHeHHR. Ha COBe!llaHHH OblJIH npe,IlCTaBJleHY BeJlbrHR, 1-iTamfR, 1-icna.HHR, HH.nepnaH,lll,I, Coe.ItHHeHHoe Kopo.neBCTBO, Coe.ItHHe!-llihle l!ITaTY AMepJ,fi(l(, <i>e.nepaTHBHaR Pecny0.11HKa repMaHHH, <l>HHJlRH,llHR I <l>paHI..tHR I IIIBeUHR H DI"OCJlaBHff. C yqeToM roro, 'ITO oOecnet1etrne Kat1ecTBa RBJIReTCR HOBYM H B TO ;,ge BpeMR lteJJaTeJlbHhlM npHHUHilOM .IleRTeJlbHOCTH eBponeHCKHX rocy.napcrB - tt11eHOB 803, nepe,o I'pynnOH OblJla nOCTaBneHa 3a.naqa pa3paCio:raTb c-rpaTenno pa3bRcHeHHR 3Toro npHl-lI.lHI@. Cpe.nH npe.ocraBHTeneH opra.HoB 3.opaBOOxpaHeHHR, Me,[lpaOoniHKOB, HayqHOH oObleCTBeHHOCTH H nauHeHTOB. YtlaCTHHJ<H rpynr11,1 nOnYTanHCb npoa.HaJlH3HPQBaTb H )laTb OTBeT Ha cne.JlYl(XllHe BOrtpOChl. - TTO'leMy cne.oyeT oOeale'IHBaTb Ka'leCTBO? - Kai<He UenH npH 3TOM npecneJlYIOTCR< - KaKOBY onnD4anbHYe nyTH BHe.opeHHR 3TOro npHHUHna Ha HauHOHaJibHON H MeCTHOM ypQBHRX< - KaKHe MeponpHRTHff ,llOJlllHY BOOTH B npaKTINecKyio nporpa)O(y oOecnet1eHHff Kat1ecTBa? - KaK MOJIHO noBYCHTb Ka'leCTBO oOcJlyEraaHHR, ecnH 3TO Heo0XO,llHMO< 1-iCXO,ItHaR Hl-ll>OPMa.l..lHR XOTR BceMHPHa.R accaMOneR 3,IlpaBOOxpaHeHHR H PerHOHa.JlbHYH KONWreT He npHHHManH KaKHX-JJHOo pe3OJDOUHH, B KOTOj)l,IX KOHKpeTHO ynoMHHaeTCR BOnpoc oOecnet1eHHR Kat1ecTBa, 33 HeoOXO,llHMOCTb B npoae,11eHID1 3TOA paOonl OtleBH,ItHa: BOnpoc oOecnet1eHHR Kat1ecraa Hamen t1eTKoe BblpaieHHe B Ycraae B03, Mec-roo H Ce,11bMOO oOblHx nporpaMMax paOonl, BO MHOrHX peKOMeH,Ilal.lWIX, KacaIOIIIHXCR pa3pa00TKH HOPM H CTaH.IlaPTOB, a Taiae oueHKH ,11eRTeJlbHOCTH ~o 3,DpaBOOXpaHeHHR. rocy,llapcrBa-t1JieHhl ace B OoJlb111eA creneHH npoRBJUDOT ot1eBH,Jl1-lhlA HHTepec K BOnpocaM oOecnet1eHHR Kat1ecrBa. BHHMaHHe, KOTopoe Cett1ac B03 y,11eJIReT oOecnet1eHHIO KatleC"l'Ba, RBJIReTCR ecrecTBeHHhlM H JlOnNHblM CJie,11CTBHeM MeportpWITHA, npoBe,11eHHhO{ paHee, C Y'{eTOM BhlllOJIHeHHR tleTKO nOCTaBJieHHOA UenH B 3TOO oOJiaCTH. H3 aHa.JJH3a O~eTOB H peKOMeH,OaUHH paOO<rnx rpynn, C03b1BaBIIIHXCR PerHOHaJll>HhlM OJOpO, BHJlHO, 'ITO KOHUern.tHR KatleC"l'Ba BCe Oom,111e CTaHOBHTCR npe,11MeTOM .11HCKYccHA no BonpocaM oueHKH ~o 3,DpaBOOXpaHeHHR H 9CW>eKTHBHOCTH HCnOJlb30BaHHR HMelO!llHXCR pecypcoB. TeMbl .11HCKYccHA H Bb1B0.l1bl 8 xo.11e COCTORBIIIHXCR .11HCKYCCHA yqaCTHHKH rpyrnlbl nonblTa.JIHCb Oonee qen<0 onpe,11e.TIHTb OnTHMaJlbHble xapaKTepHCTHKH nporpaMM oOecneqeHHff Kaqecraa. BbiJI c.nenaH BblB0.11 0 Heo0XO,llHMOCTH oOecnetleHHR Ka'ieCTBa. KaK H B yCJIOBHRX npoH3B0.11CTBa, 3<M)eKTHBHble MeXaHH3Mbl oueHKH H COBepmeHCTBOBaHHR Kat1ecTBa Me,DHKO-CaHHTapHoA noMOIIIH RBJIFDOTCR cyl!leCTBeHHblMH KOMilOHeHTa.MH moOoA CHCTeMhl 3,DpaBOOXpaHeHHR. C YCJIOJIHeHHeM xapaKrepa H YJ(penJieHHeM TeXHJiqecKHX B03MOllHOCTeA CHCTeM Me,11HKO-CaHHTapHblX c~O B pa3BHTblX CTpaHax EBponbl H .11PYrHX paAoHax MHJ)a CTanO ot1eBH.11HblM, tlTO cyl!leCTBYJOl!lHe MeT0.11b1 KOHTpoJIR KatleCTBa (TaKHe, KaK Bbl,Ila'ia COOTBeTCTBy!OblHX pa3pe111eHHA nepcoHaJTy H yqpell(.IleHHRM) He MOryT oOecnetnITb Ha,11Jlellal!lHA KOHTPOJlb 3a KatleCTBOM oOc.ny)IHBaHHR. Il09TOMy B03HHJ<Jla HeoOXO,llHMOCTb B HOBblX MeTO.nax H MexaHH3Max oOecnet1eHHR KatleCTBa ,11.TIR Toro, qTO(;,i,i HaceneHHe MOr"JlO KOHTJX)JIHPOBaTb ,11eRTeJibHOCTb Me,11HUHHCKOro nepcoHaJJa H Y'{pellUleHHA 3,DpaBOOxpaHeHHR. PaOotlaR rpynna npH11111a K 3aKJUOtleHHIO O TOM, 'ITO B03 ,110.TDIHa HrpaTb Be.JlYD!YlO poJlb B .11eRTeJibHOCTH, cnocoOCTBYIOl!lel pa3pa00TJ<e, YJ(pellJleHHJO H BHe,llpeHHJO 3¢cl>eKTHBHblX MeXaHH3MOB oOecnet1eHHR Kat1ecraa B eBponetcKHX rocy,llapcrBaX-qJieHax. XOTR xapaKTep KOHKpeTHl,VC MeponpHRTHA, KOTOpble Oy.nyT np0BO,l1HTbCFI CTJ)aHa.MH, 3aBHCHT OT npeBaJIHpytOl!leA B HHX 34 COUHaJtbHO-nomrr!-NecKOH oOC'raHOBKH H Ha.11J.NHR nepcoHa.na, Pa0o'l:aR rpynna C'-IHTaeT, 'l:TO CJ1e.IlYl()IJ1}ie ceMb OCHOBHblX npHHUHilOB MOryT OblTb HcnOJlb3OBaHbl 803 H eBponeHCl<HMH rocy.oapcrBaMH-'l:JleHaMH B Ka'l:ecTBe peKOMeHJlfillHH npH opra.HH3aJ.lHl,i paOoTbl, CBR3aHHOH C pa3paOon<oo 3<fxl)eKTHBHoro H .IleHCTBeHHoro no.nxo.Ila K oOecneqeHHJO Ka'l:ecTBa Me.IlHKO-CaHHTapHOH nOMQlltH. 1. Hcn0.1lb3yeMb1e MeTO.llbl .IlO.lllKHbl cnocoOC'rBOBaTb onpe,Ile.neHHJO H pell!eHHJO npoOneM opraHH3auHH ~o 3.ItpaBOOXpa.HeHHR, onpe,Ile.neHHJO B03MO:n!OCTeH COBepll!eHCTBOBaHHR oOc.rrymiBaHHR B UeJIRX oOecne'l:eHHR ~H31-NecKOro, nCI-OC}fqecJ<OrO H COUHaJlbHOro OnarOCOCTORHHR naUHeHTOB. 2. Mepbl no oOecneqeHHJO Ka'l:ecTBa .IlO.lllKHbl pa3pa6anrnaTbCR c Y'l:eTOM TaKHX noHRTHA, KaK ,IleHCTBeHHOCTb, PHCK H 94>¢eKTHBHOCTb B UeJIRX CO.IleHCTBHR pa3BHTHIO noMOl!lH, nO3BOJlffiOllleH .IlOCTHrHyTb onTHMaJtbHblX pe3y.TibTaTOB npH MHHHMaJibHblX 3aTpaTaX H C MHHHMaJtbHblM PHCKOM HaHeceHHR Oom,mero Yll!epOa 3.IlOPQBb!O Oom,HblX. 3. Cne..oyeT Y.IleJIRTb BHHMaliHe pa3paOon<e nporpaMM, BKJilO'l:aKll!tHX 3MOUHOHaJtbHhle H COUHaJtbl-lble acneKTbl Ka'l:ecTBa Me.llHl<O-CaHHTapHoo noMOl!lH, a Ta~e HaY'-ffiO-Texl-lW-lecKHe acneKTbl. 4. Mepbl no oOecneqeHHJO Ka'l:ecTBa .IlO.lllKHbl CTaTb COCTaBHOH 'l:aCTb!O .IleRTeJlbHOCTH KJlHHHl..lHCTOB H paoorHHKOB CTauHOHapoB, a TaKJKe yqpeJK.IleHHH 3.IlpaBOOxpa.HeHHR, HX He cne..oye-r npoBO.mrn, OT.Ile.TibHO HJ1H 1-13O.TIHpoBaHHO. 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