The system of clinical audit

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Chair of clinical pharmacology and evidence medicine.

Discipline of «Based evidence medicine».

Course 3

Speciality 051301 «General medicine».

THE INFORMATION-DIDACTIC BLOCK

ON «Based evidence medicine»

TO PRACTICAL EMPLOYMENT № 10, 11.

Theme «the Fourth and fifth stages of EM. Application of the received data in practice. Approximate planning and carrying out of clinical audit. The analysis of errors and planning of repeated audit.»

Introduction

The institute medicine (USA) has defined quality of public health services as degree of that, how much medical services given to separate persons and groups of the population, promote improvement of a state of health and how much their level corresponds to modern level of knowledge in the field of medicine.

Thus, it is necessary to understand the maintenance and the form of interaction of the doctor as quality of medical aid (the personnel, medical institution, the supplier of medical services) and the patient which is directed on achievement of desirable results - satisfaction to requirements of the patient taking into account modern possibilities of a medical science and practice with optimum use of available resources of public health services. One of difficulties of definition of quality of medical aid consists in its internal subjectivity. For its overcoming it is necessary, that examination was spent by uniform methodological principles and technologies.

Quality of medical aid is traditional is estimated in three general directions: to structure, process and results (outcomes).

The structural estimation puts problems on revealing of characteristics of persons and the organizations, rendering medical services, and places where it occurs, in the quantitative plan.

The process estimation assumes the miscalculation of probability of unexpected situations which the organizations of public health services can face and which can affect result of treatment of the patient with the obligatory analysis of technology of medical-diagnostic process.

The result estimation represents definition of results after treatment and comparison of observable results with the standards established on the basis of scientific and clinical estimations. In practice by productivity indicators can serve medical (the general indicators of recover, improvement, deterioration etc., special indicators for concrete specialities), economic (indicators of efficiency of financing, use of financial assets), social (satisfaction as quality of medical aid, etc.) indicators.

There are international recommendations according to quality of medical services - clinical audit.

Clinical audit - qualitative process of improvement which aspires to improve medical aid and its results through comparison of the systematic review to accurate criteria and provides change performance.

Define following stages of clinical audit - preparation for audit, selection of criteria, level measurement, creation and support of improvements.

Treatment audit is offered to be spent on 10-step system:

1) responsibility definition;

2) treatment scoping;

3) definitions of prominent aspects of treatment;

4) definition of indicators of quality which should be defined for each prominent aspect of treatment;

5) an establishment of thresholds for indicators;

6) gathering and sorting of the data;

7) a treatment estimation;

8) the decision of questions on quality improvement;

9) an estimation of actions and ascertaining of improvements;

10) information transfer in corresponding programs depending on the purposes of spent audit.

As it was marked World Health Organization makes considerable efforts for perfection of practice of use of medical products, in particular, to questions of rational use of medical products and problems of its estimation. In this connection, there was a necessity for an objective method of quantitative definition of parameters for an estimation of the settled templates of use of medicines and behavior at appointment of preparations. There was a necessity for an appropriate estimation of quality of use of the medical products, needing standardization and objectivization. The World Health Organization together with the international organizations has developed the program of an estimation of use of medical products in medical institutions, including a primary medical link. Given program of an estimation of use of medical products is directed on maintenance expense - effective rational appointment and use of medical products by comparison of their application with the established standards. The program is intended basically for the analysis of practice of appointment and application of separate medical products with use of the basic and additional indicators.

To the basic indicators carry base indicators which are highly standardized and don't demand adaptation. Therefore they also are recommended for inclusion in any research on medicines with application of indicators. The basic indicators of use of medical products are the simple tool for a fast and reliable estimation of several solving aspects of application of medicines in primary system of public health services. Them concern: percent of the medical products registered from ПЖВЛС or from the data card, percent of references when antibiotics and injections, etc., average of the registered medical products on each medical reception leave. Additional indicators are defined in addition to the cores. These indicators aren't less important, but frequently it is more difficult to measure them, and sometimes and it is impossible to measure authentically. Besides, additional indicators are to a lesser degree standardized, as many of them depend on local variable factors which are necessary for defining before indicator use. Examples of additional indicators: percent of cost of antibiotics in a total cost of medical products, costs injections preparations, percent of the patients satisfied with the received help, prescription medical products according to managements on treatment.

Available indicators concern basically practice of prescription of medicines. At the same time, program of an estimation of use of medical products doesn't provide technology on examination of medicamentous therapy of concrete diseases

The technique the review/estimation of use of medical products also can be a component of programs of an estimation of use of medical products, clinical audit. It has been developed at level of a hospital and provided for an estimation of validity of use of medical products.

On the other hand, the program of an estimation of use of medical products can be a part of official system or can separately be spent within the limits of audit.

Estimation of quality of medicamentous therapy. Clinic-pharmacological examination

The system of quality of medical aid in Kazakhstan has started to be formed since 1996 in the conditions of introduction of obligatory medical insurance when parameters of an estimation of medical aid for the first time have been defined. There was a system of penal sanctions which in the subsequent has been replaced by the analysis and an estimation of quality of medical services. In this connection criteria (definition of conformity of the rendered medical services to medical standards have been developed; carrying out of an estimation of quality of medical services; studying of satisfaction by patients) on which examination was spent. It is known that the basic problems at monitoring procedure of quality of medical aid lie in a plane of technological level, namely in an objective estimation of treatment. Thus it is necessary to remember that medicinal therapy as it was marked, makes 30-70 % of all activity of the doctor that, in turn, defines the importance of medicamentous examination at an estimation of quality of medical aid. Practice shows that experts differently estimate medicamentous therapy spent by doctors, being limited to the general aspects and simply estimating debatable positions of pharmacotherapy that is connected with absence of the general criteria of definition of quality and methods of their measurement.

Considering all these problem aspects, own working out on clinical-pharmacological examination of medicamentous therapy is offered.

Clinic-pharmacological examination of medicamentous therapy

Clinic-pharmacological examination is realized by examination, the analysis and an estimation of quality of medicamentous therapy. The estimation of medicamentous therapy from the point of view of degree of its condition is given on the basis of the analysis of medicamentous therapy. The analysis of medicamentous therapy, in turn, is spent on the basis of consideration of separate results Clinic-pharmacological examination of medicamentous therapy.

Considering that Clinic-pharmacological examination should give the information on conditions of essential signs of medicamentous therapy, necessity of decomposition of process of medicamentous therapy on corresponding significant components with an estimation of each of them became a starting point at its substantiation.

There was thus a necessity of allocation of key parameters with

Their intensive estimation. In this connection differentiation has been spent

Concepts "parameter" and "indicator" with a view of formalization of terms and

Their forthcoming functional loading. So parameter in a context

Examinations of medicamentous therapy should be understood as measured

The variable reflecting this or that making part

pharmatherapeutic process or its results. The indicator -

The measured variable reflecting a part pharmatherapeutic of process or its result, but within the limits of certain parameter and which serves for its intensive estimation.

Clinic-pharmacological examination it is based on carrying out of the analysis of rationality, safety and efficiency of pharmacotherapy, comparison of actually carried out actions for medicamentous therapy and the reached results by comparison to the confirmed clinical reports (standards) of diagnostics and treatment and it is spent by results of the analysis of the clinical, tool, laboratory data and records of the doctor on a medical card stationary or the outpatient.

Clinic-pharmacological examination for an estimation of quality of medicamentous therapy it is spent on following parameters:

1. An estimation of conformity of medicamentous therapy under the confirmed clinical reports (standards) of diagnostics and treatment (depending on level of rendering of medical aid), appointments of the basic (official) medical products.

2. An estimation of a choice of medical products on the basic disease and taking into account an accompanying pathology, including prescription of medicines without accurate indications and-or with not proved efficiency, and physiological conditions (age, pregnancy, etc.).

3. An estimation of a mode of dispensing and a choice of ways of introduction of medical products.

4. An estimation of interaction of medical products, risk of development or presence of undesirable collateral actions (reactions), cases полипрагмазии.

5. An estimation of clinical efficiency (purpose achievement

Medicamentous therapy) and control of medicamentous therapy on a basis

Carrying out of a necessary complex clinical, laboratory -

Tool researches.

Indicators are applied to an intensive estimation of the specified parameters.

Following indicators are applied to an intensive estimation of 1st parameter:

1.1 conformity of medicamentous therapy to reports (standards);

1.2 appointment of the basic (official) medical products.

Following indicators are applied to an intensive estimation of 2nd parameter:

2.1 medicinal anamnesis;

2.2 conformity of medicamentous therapy to the leader

etiologypathogenetic to the factor;

2.3 rationality of prescription of medicines on the core

To disease;

2.4 rationality of prescription of medicines taking into account accompanying disease;

2.5 rationality of prescription of medicines taking into account a physiological profile of the patient;

2.6 appointment of unreasonable medical products (without the accurate

Indications);

2.7 prescription of medicines with not proved efficiency.

Following indicators are applied to an intensive estimation of 3 parameters:

3.1 rationality dose mode (single, daily,

Supporting);

3.2 rationality of a course mode;

3.3 rationality of a choice of ways of introduction of medical products. The following is applied to an intensive estimation of 4th parameter indicators:

4.1 use of the confirmed schemes of combinations medicinal means;

4.2 rationality and safety of combinations of medical products;

4.3 collateral action of medical products connected with

not rational medicamentous therapy;

4.4 correction of undesirable collateral actions (reactions);

4.5 presence полипрагмазии

Following indicators are applied to an intensive estimation of 5th parameter:

5.1 correction of medicamentous therapy;

5.2 control of medicamentous therapy (on the basis of an analytical estimation of records of the doctor and a necessary complex of clinical, laboratory-tool researches);

5.3 achievement of the purpose of medicamentous therapy at level of rendering of medical aid.

Each indicator of the corresponding parameter is estimated on the following scale (in points):

"0" - irrational, inadequate carrying out of medicamentous technology, negative results on corresponding indicator; «0,5» - incomplete conformity of spent medicamentous technology to the corresponding indicator;

«1,0» - rational, adequate carrying out of medicamentous technology, positive results on corresponding indicator.

The estimation of each parameter of medicamentous therapy represents an average arithmetic separate estimations of indicators. The integrated characteristic of quality of medicamentous therapy (QMT) represents an average arithmetic all five parameters.

Considering a step of an estimation of indicators, the following scale for an integrated estimation of quality of medicamentous therapy is proved: 0,84-1 high level, 0,68-0,83 - good, 0,51-0,67 - average and 0,5 and less - a low degree of quality of medicamentous therapy.

In more details the technology of calculation of a scale of points for an estimation of quality of medicamentous therapy is resulted more low.

The developed indicators also can be used as estimated criteria at carrying out of pharmacological epidemiological researches.

QMT to medicamentous therapy in the public health services organizations should it is spent by the doctor - the clinical pharmacologist or the expert who having the experience of clinical work and has passed thematic improvement on clinical pharmacology. Thus the doctor - the clinical pharmacologist can be involved for carrying out QMT of medicamentous therapy within the limits of departmental or non-departmental quality assurance of medical aid.

QMT medicamentous therapy it is carried out retrospectively or prospective. Prospective QMT it can be spent within the limits of current advisory work of the doctor - the clinical pharmacologist to the public health services organizations. Obligatory QMT medicamentous therapy it should be spent at lethal cases, development of complications and low efficiency of medicamentous therapy, and also at occurrence of questions at issue according to quality of medicamentous therapy from the interested organizations, and also at complaints of patients or their relatives. QMT medicamentous therapy it can be spent under the order of administration or is official-therapeutic committee of the organization of public health services at the decision of certain tactical questions of rational use of medical products. QMT can be integrated into various programs on quality assurance of medical aid and an estimation of use of medical products in the public health services organizations.

Table 1 - Parameters (indicators) for carrying out of examination and a scale for definition of quality of medicamentous therapy

Parameters/indicators	a scale (points))	comment (in case of understating of a point of the indicator)
1. An estimation of conformity of medicamentous therapy to the confirmed clinical reports (standards) of diagnostics and treatment, appointment of the basic (official) medical products 1.1 Conformity of medicamentous therapy to reports (standards) (yes; not to the full; isn't present) 1.2 Appointment of the basic (official) medical products (yes; not in To full measure; isn't present)
2. An estimation of a choice of medical products on the basic disease and taking into account an accompanying pathology, including prescription of medicines without accurate indications and with not proved efficiency, and physiological conditions (age, pregnancy, chest feeding). 2.1 Medicinal anamnesis is displayed (yes; not to the full; isn't present) 2.2 Conformity of medicamentous therapy to the leader etiological pathogenetic factor (yes; not to the full; isn't present) 2.3 Rationality of prescription of medicines on the basic disease (yes; not to the full; isn't present) 2.4 Rationality of prescription of medicines taking into account accompanying disease (yes; not to the full; isn't present) 2.5 Rationality of prescription of medicines with the account Physiological profile of the patient (yes; not in the full To measure; isn't present) 2.6 Appointment of unreasonable medical products (without accurate indications) (yes; isn't present) 2.7Appointment medical products with not proved efficiency (yes; isn't present)
3. An estimation of a mode of a dose and a choice of ways Introductions of medical products 3.1 Rationality of a mode of a dose (single, daily, supporting) (yes; not to the full; isn't present) 3.2 Rationality of a course mode (yes; not to the full; isn't present) 3.3 Rationality of a choice of ways of introduction of medical products (yes; not to the full; isn't present)
4. An estimation of interaction of medical products, risk of development or presence of development of undesirable collateral actions, cases полипрагмазии 4.1 Confirmed schemes of combinations of medical products were carried out (yes; isn't present) 4.2 Combination of medical products was rational and/or safe (yes; not to the full, isn't present) 4.3 medical products revealed collateral action have been connected with not rational medicamentous therapy (yes; isn't present) 4.4 correction not the desirable collateral Was spent Actions (yes; not to the full; isn't present). 4.5 Presence полипрагмазии (yes; isn't present)
5. An estimation of clinical efficiency (achievement the purposes of medicamentous therapy) and control of medicamentous therapy on the basis of carrying out Necessary complex of clinical, laboratory-tool researches. 5.1 Correction of medicamentous therapy was spent (Yes; not to the full; isn't present) 5.2 Control of medicamentous therapy was spent (on The basis of an analytical estimation of records of the doctor and necessary complex clinical, laboratory - Tool researches) (yes; not to the full; isn't present) 5.3 Achievement of the purpose of medicamentous therapy at level of rendering of medical aid (yes; not to the full; isn't present)

The note: the Scale of points is estimated as follows:« Yes »- 1 point,"not to the full"- 0,5 point,"no"- 0 point, except for indicators № 2.6; 2.7; 4,3; 4.5. At revealing of prescription of medicines without the accurate indications, the proved efficiency and полипрагмазии, and also collateral action of medical products which has been connected with irrational medicamentous therapy«0»point is exposed, and at their absence -«1»point. An estimation of indicators 2.4; 2.5; 4.1; 4.3; 4.4; 5.1 it is not spent in cases of absence of events on them or necessity of their carrying out that demands corresponding correction of calculation of the corresponding parameter. The indicator 4.1 is estimated in cases of necessity of accent on conditions of strict observance of combinations of medical products (for example, performance эрадикационных schemes). In case of reception negative results on 1 and 2 parameters the further examination isn't spent, and quality of medicamentous therapy is estimated as low.

Accreditation of objects of public health services in Republic Kazakhstan

The problem of increase of a degree of quality of medical aid is one of actual in public health services system. For its decision various ways are offered, certain mechanisms, among which - system of accreditation of the medical organizations in which a special place occupy development of corresponding methods of maintenance of quality of medical aid, estimations of conformity to standards of all process of activity of the medical organization and forecasting for certain terms of maintenance of this quality activity are developed. As domestic and foreign authors, accreditation mark, being the tool of realization of external control, is necessary, first of all, for the medical organization. It is original pledge of increase of its competitiveness in market conditions. Accreditation reception testifies to conformity of concrete establishment of public health services to certain standards of organizational, legal, clinical technologies and to the requirements developed by corresponding experts and providing high level of activity of all establishment.

Accreditation, unlike licensing, traditionally means high standards, its purpose - constant increase of efficiency of granting of medical services concerning a minimum level.

One of accreditation main objectives is association of all interested parties in effective work of system of medical aid, increase of level of health services at maintenance of establishments of public health services with an effective management by perfection of management methods not only thanks to revealing of lacks of establishment work, but also search of ways of the decision of existing problems. The strategy, standing up for accreditation procedure, consists in assistance, training and the help to the organizations in development of constantly operating process of improvement of quality. Its problem - to develop the interdisciplinary approach to leaving and treatment of the patient and to give the chance to the professionals working in the organization, to be responsible for quality. Focus of process of accreditation should displace accent from inspection on a place with search and revealing of defects, to constantly operating process of acknowledgement on conformity to standards. Control on a place should become only a making part of constantly operating process directed on maintenance of quality of medical aid.

The accreditation system in public health services sphere was widely adopted in many countries of the world. Most the wide experience is saved up in the USA, Canada, Great Britain which take in the lead positions in working out of methodology of accreditation and figure at propagation of innovative ideas in the international community in training of experts to high technologies in the field of an estimation and the analysis of quality of medical aid.

It is necessary to notice that the system of accreditation of the medical organizations successfully functions in various models of public health services, at various sources of financing. Accreditation with success is spent as at state, so private and insurance model of public health services.

Besides, in the majority of the countries for accreditation carrying out there are organizations both state, and the nonstate type which certificate admits the customer of medical services as the guarantor of rendering of medical aid. Forms of its carrying out can be the diversified - from a self-regulation before carrying out of a professional estimation and the state check.

Irrespective of it, at accreditation carrying out such main principles, as voluntariness of participation of the applicant, a self-appraisal on the basis of standards of accreditation and own standards, an external estimation of quality of services on conformity to the certain quality standards, not simply control and examination, and search of optimum ways of a solution of a problem by joint efforts are observed.

At the same time in a number of the countries accreditation passage is an obligatory, necessary condition for participation of the medical organization in realization of the state guarantees. Though initially programs of accreditation carried the voluntary, desirable, structurally focused and confidential character. Now changes on each of key parameters that is caused by constant search of optimum tools and levers of influence on quality of given services are possible. So, obligatory accreditation as in France and Spain, grants to hospital the right to financing and is directed on maintenance of comprehensible standards in all hospitals. Voluntary accreditation as in the USA, Canada and Australia, raises public and professional prestige of hospital, offers to it certain advantages before competitors.Такое многообразие деятельности свидетельствует о растущем стремлении найти такие методы аккредитации, которые обеспечат наибольшее повышение эффективности национальных систем здравоохранения.

Обобщая международный опыт по вопросам аккредитации, необходимо отметить, непрерывность в повышении качества медицинской помощи во многом обеспечивается функционированием служб внутреннего аудита, проводящим самооценку и разработку мер по совершенствованию процесса.

Working out and updating of standards of accreditation is carried out with participation of all interested parties that allows to make them the working standard procedures which performance promotes medical aid improvement of quality. The estimation of degree of conformity to standards is spent from an estimation position «equal equal», in case of standard default there is no retaliatory mechanism that stimulates the medical organizations to the independent decision of problems.

Especially important is that the accreditation certificate has certain period of validity upon termination of which repeated examination is spent that also promotes development and realization of the concept of a continuity of improvement of quality.

Thus, on the basis of experience of foreign countries in the field of improvement of quality of medical aid and the situation analysis in domestic public health services it is offered to introduce system of accreditation of the medical organizations of Republic Kazakhstan as one of effective mechanisms of increase of a degree of quality of given medical services.

Legislative and it is standard - legal base of process of accreditation in Republic Kazakhstan

For the first time the concept of accreditation of public health services is fixed in the Law of Republic Kazakhstan from June, 4th, 2003 N 430-II «About public health services system»: «accreditation of the organizations of public health services is spent by the authorized body in the field of public health services with a view of a recognition of their status and competences to be engaged in medical, medical, pharmaceutical, scientific and educational activity according to the Republic Kazakhstan legislation».

According to this Governmental order of Republic Kazakhstan from January, 8th, 2004 № 15 «About the statement of Rules of accreditation in the field of public health services» are defined an order and rules of carrying out of this procedure.

The decree of the President of Republic Kazakhstan from September, 13th, 2004 № 1438 confirms the Government program of reforming and public health services development for 2005-2010. In the present program development of system of accreditation in public health services sphere as one of mechanisms in realization of regulating function of the state in a control system of quality of medical aid is provided.

In this connection in the Plan of measures on the Program realization, confirmed the Governmental order from October, 13th, 2004 № 1050 provides entering of respective alterations and additions into standard legal certificates concerning accreditation of the medical organizations with participation of independent experts.

On July, 7th, 2006 the Republic Kazakhstan Law № 171-SH ЗРК «About modification and additions in some acts of Republic Kazakhstan concerning public health services» had been introduced respective alterations in the Law of Republic Kazakhstan from June, 04th, 2003 «About public health services system». In article 1, point 1 definition of accreditation which is stated in the following edition is made: «Accreditation - procedure of a recognition of the special status and competences physical and legal bodies for realization of medical and pharmaceutical activity, and also for carrying out of an independent expert estimation of activity of subjects of public health services according to the established standards of accreditation».

The given Law also defines the competence of the Government of the Republic Kazakhstan, the authorized body, a state structure on control in sphere of rendering of medical services, including accreditation process. So, Government RK defines an order of accreditation (item 6.9), the authorized body in the field of public health services defines an order of carrying out of an independent expert appraisal (item 7.12), confirms standards in the field of medical and pharmaceutical activity (item 7.9); the state structure on control in sphere of rendering of medical services carries out accreditation of subjects of public health services (item 7-1.7), carries out accreditation physical and legal bodies for carrying out of an independent expert appraisal of an estimation of activity of subjects of public health services (item 7-1.8), forms a databank of independent experts from among experts of various profiles (item 7-1.9).

Besides, Law article 11 defines that «accreditation in the field of public health services is carried out on the basis of an external complex estimation of activity of subjects of public health services and carries a voluntary nature. The subject of accreditation can be physical or the legal body corresponding to established standards of accreditation. Independent experts can be involved when due hereunder for carrying out of examination of activity of subjects of public health services, accreditation, certification, licensing and carrying out of promotion examinations in the field of public health services».

In execution of the above-stated Law by Governmental order РК from October, 31st 2006г. № 1030 changes and additions Governmental order РК from January, 8th, 2004 № 15 «About the statement of Rules of accreditation in the field of public health services», regarding rules of accreditation of objects of public health services and independent experts have been made.

Now the Governmental order of Republic Kazakhstan from October, 12th, 2009 № 1559 «About the statement of Rules of accreditation in the field of public health services» which is some kind of compilation before operating regulatory legal acts operates.

Thus, now the preparatory stage on working out of a legislative is standard-legal basis for accreditation introduction in public health services sphere, is almost finished. The structure of system of accreditation, participants of process, their interaction, algorithms, activity principles that will allow to provide in the greatest measure effective functioning of process in public health services is defined.

Accreditation of the medical organizations in Republic Kazakhstan: main principles, problems, participants

Main principles of accreditation of the medical organizations in Republic Kazakhstan concern:

- Objectivity and impartiality of an estimation;

- Voluntariness;

- A transparency of process of accreditation;

- Aiming at maintenance of the rights of patients;

- Maintenance of confidentiality of the information received in the course of an estimation and accreditation;

- Application of the standards operating in the field of medicine;

- Possibility of the appeal of the decision accepted as a result of an estimation of establishment;

- Population maintenance with qualitative medical services.

Accreditation problems is the following:

- Carrying out of an estimation of quality and safety of medical aid;

- Carrying out of an estimation of ability of the medical organization to provide constant improvement of quality on rendering of services to patients;

- Formation of practical recommendations about improvement of quality of medical aid;

- Involving of professionals at all stages of the initiative on quality improvement;

- Maintenance of social recognition of quality of medical services in the organization;

- Strengthening of trust of the population.

Participants of process of accreditation are:

- Ministry of Health

- Committee on control in sphere of rendering of medical services

- Accrediting department (the Commission on accreditation)

- Akkredituemaja the medical organization (Applicant)

- Independent experts

- Consumers of medical services

- The centers of standardization and an estimation of technologies

Interaction of participants of process is carried out at all stages of accreditation from the beginning of introduction of standards before reception by object of public health services of the certificate on accreditation and the subsequent periodically spent monitoring of standards. The interaction scheme is shown in drawing 1.

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Drawing 1 Interaction of the basic participants of accreditation as the process providing quality of medical aid

Algorithm of carrying out of accreditation

As any process, accreditation consists of a number of the consecutive stages occupying a certain time interval. It is necessary to notice that before the beginning of a preparatory stage and a self-appraisal in the organization the service of intrahospital quality assurance of services (intrahospital audit) should be generated. Depending on the size of the organization and quantity of the divisions entering into its structure, the service can include a various set of experts from one to seven.

1. Carrying out of internal preparation and a self-appraisal

Depending on degree of preparation of object occupies from 3 till 12 months (the given terms are specified on the basis of carrying out of questioning of the medical organizations rendering ВСМП). According to the international experience of introduction of the quality standards and formation of a control system by quality on objects of public health services approximate term of introduction of standards makes from 12 till 24 months.

1.1. Filing of application the head of the medical organization on passage of accreditation to accrediting body. (Secretary of the Commission on accreditation at a state structure on control in sphere of medical services).

1.2. Carrying out of preparatory measures on object on training of technology of a self-appraisal under standards of accreditation and preparation of a necessary package of documents, formation of working groups of experts of intrahospital audit and heads of divisions.

1.3. At this stage training seminars are held on training of the personnel of clinic and working group of intrahospital audit of methodology of carrying out of an estimation about conformity of accreditation to criteria, formation of a necessary package of documents. For training carrying out the Centers and experts will be involved.

1.4. Carrying out by the Applicant of a self-appraisal under accreditation standards on the developed methodology (an internal estimation on conformity degree).

The self-appraisal under accreditation standards is spent according to the developed methodology by service of internal control which structure includes experts in a profile, responsible for performance of blocks of standards. At this stage probably attraction of independent experts. Following the results of check the self-checking certificate in which is made out data on all divisions of the organization are reflected. Estimated tables of standards, and also the summary report by results of checks in the last two days, both planned, and target, road, off-schedule should be the appendix to the certificate. The specified forms are represented to external experts for the further work. With external experts the agreement on nondisclosure of the information in an organization self-appraisal according to established forms subscribes.

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Drawing 2. 1 stage of accreditation: introduction of standards, self-checking (internal audit)

2. An external estimation

The external estimation of performance of standards on accreditation by expert group is carried out during from two weeks till 1 month.

2.1. The accrediting body considers the documents received from the Applicant according to the list provided by the governmental order of Republic Kazakhstan from January, 8th, 2004 № 15. The self-appraisal Certificate, the Summary report also goes To the commission.

2.2. Then the Accrediting department forms a team for carrying out of an external estimation with attraction of independent experts, the volume of forthcoming works, and also specificity of activity of the Applicant is thus considered.

2.3. The commission and experts makes the inspection plan.

2.4. The group of the appointed experts spends an independent expert appraisal of object with formation of the decision of an expert consultation about level of the organization and quality of given services accrediting object according to accreditation standards.

Creation of "command" of experts will allow to provide objectivity of process. The team of experts represents multidisciplinary group and consists, at least, of 3 persons. At least one of experts should have practical experience in that area in which the organization specializes accrediting. One member of team carries out a role of the leader-coordinator. For maintenance of sequence and observance of uniform requirements at carrying out of procedure of accreditation in the various organizations, it is necessary for experts to be guided «by Position about the expert and an expert consultation» which defines conditions and requirements of performance of mission of the expert and serves as the guarantor both for the Commission on accreditation, and for аккредитуемой to the organization.

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Drawing 3. 2 stage of accreditation: external, an independent expert appraisal.

3. Expert judgement formation.

The expert judgement is formed upon termination of inspection during from one about two months. On the basis of results of a self-appraisal and inspection the report, two-piece is made. The first part - an estimation of methods of carrying out of the self-appraisal, the second part - an estimation on conformity to standards. The report is made in the structural form developed by the Commission. The report is represented to the organization not later than in two months after inspection end.

Comments of the organization concerning the report can be presented within one month after report reception. They can contain the plan of improvement of quality in the light of recommendations and / or indicators of measurement of efficiency of measures. medicamentous therapy service accreditation

4. Decision-making on accreditation

Consideration of the documents presented by the Applicant, is carried out at Commission session according to its Position. Following the results of studying by the Commission of documents the decision on accreditation (or refusal in accreditation) and delivery (refusal in delivery) certificates on accreditation is made.

To the subject of the public health services who have passed accreditation, the certificate on accreditation under the form confirmed by accrediting body for a period of 3 years is granted.

Drawing 4. Algorithm Accreditations (scheme).

Classification design of standards of accreditation,Estimation of execution of standards

The basic focus of standards in the various countries, despite that public health services control systems different and accreditation procedure has the features, concentrates on protection of the rights of the patient and safety of the personnel. In accreditation standards, practically standards are developed for all services and processes which for today exist in the public health services organization in RK. As it is the first experience for Republic Kazakhstan on creation of system of accreditation and definition of its criteria (standards) at a today's stage blocks of obligatory standards basically were developed taking into account is standard legal certificates by which work in the organization is regulated. More low we result classification of standards to demonstrate which sections, works, divisions, the system of accreditation of objects of public health services will concern.

1. Classification of standards;

Blocks of standards:

1. The organization and management

1.1. The legal status

1.2. Planning and the reporting

1.3. Information support

1.4. Office-work

1.5. Organizational-economic activities

2. Medicinal maintenance

3. Management of shots/personnel selections

3.1. Training

3.2. Personnel selection (duty regulations)

4. Quality management and safety of medical services

4.1. The organization and planning

4.2. Documenting of working procedures

4.3. An estimation and medical aid improvement of quality

5. Clinical activity

5.1. The organization and planning

5.2. Documenting of working procedures

5.3. An estimation and improvement of quality

6. Safety of environment

6.1. The organization and planning

6.2. Documenting of working procedures

6.3. The Organizational-economic part

6.4. Food service.

7. Infectious control, safety of patients and the medical personnel

7.1. Clinical safety of the patient and the personnel

7.2. Infectious control

7.3. Instructing in safety precautions, periodic preventive medical inspections of employees

8. The rights of patients, studying of level of satisfaction by quality of medical aid

8.1. System of maintenance of the rights of patients

8.2. The organization of rest and care of patients.

1. Design of the standard;

Let's consider design of the standard on the given example:

Table 2.

№	Standard section
1	Serial number according to classification (1.4.6.)
2	Standard requirements (A; B; C)
3	Information source (medical documentation and others)
4	Estimation of performance of the standard (criterion)

The standard 0.0.0. Medical cards of inpatients are stored according to the established order.

Standard requirements.

Medical cards of inpatients during stay in a hospital are stored in a special place (in ординаторских, on a post of the staff nurse in a case or a table only for the writing of directions on carrying out of procedures and gluing of analyses and results of researches) and placed in a folder from a strong material.

Medical cards of inpatients for organization limits aren't taken out (except for the special cases established by standard legal certificates).

Information sources:

- Survey of medical cards and places of their storage;

- Personnel interviewing.

Estimation of performance of the standard.

At survey of places of storage of medical cards the basic requirements of the standard aren't broken, medical cards of patients are stored in inaccessible to patients and visitors a place, at the same time the organization personnel has access to the medical documentation of patients being on treatment. The order of delivery of the medical documentation is confirmed and is carried out. The medical documentation isn't taken out from the medical organization a demon of corresponding instructions.

The standard is made so that it was clear to the expert, what exactly is required in the standard where to search for the information and the certificates confirming conformity to requirements of the standard. The most basic section of the standard is the Estimation of performance of the standard - section, in which is described what to consider as the executed requirement of the standard. The design of the standard considers that two parties will use the information they are experts of intrahospital audit and the independent, external experts estimating performance of the standard in accreditation.

3. An estimation of performance of the standard.

The appendix to standards is the estimated table with which experts, both in a self-appraisal, and in accreditation should fill. At a stage of a self-appraisal also it is necessary for experts to give to the head of the organization the analysis of the outstanding or partially executed standards. The analysis in the subsequent will help to develop tactics and actions for elimination of the revealed lacks.

Table 3. The estimated table for accreditation standards.

Standard № ___	executed	partially executed	Not executed	note
А				The reasons not performance
B
Quantity of points

expert name:________________________________________________

signature:_____________________________________________________

The estimation of standards is made on two-point system:

- 2 points - the standard is executed;

- 1 point - the standard is partially executed;

- 0 points - the standard isn't executed;

The column «Quantity of points» reflects total quantity of points in the standard which will be compared to the standard. After estimation carrying out the Summary table of an estimation of standards is made out and the total of points is counted up. The standard is hundred percentage execution of all standards on which the estimation was made. Further, probably to divide standards on: partially executed, also aren't executed, to count them in a percentage parity from total number of standards on which the estimation was made. To analyse each of them. In our opinion it is not necessary to complicate system of an estimation of standards that at experts remains to more time for the analysis and decision-making. The given estimated system is recommended to be used and for experts of intrahospital audit who will spend introduction of standards, self-checking and for independent experts who will examine in accreditation. Verification of certificates of self-checking and the certificates filled with external experts on accreditation becomes an important point. Such comparison with the subsequent analysis will help experts of intrahospital audit to open defects and to make decisions concerning execution and elimination of some defects connected with introduction of standards.

During the period to preparation for external examination of object, it is necessary to study it preliminary and to estimate what execution of standards in it probably and what aren't present. For example, if ВСМП doesn't render the surgical help to the population it is necessary to exclude in advance those standards which concern it. Further the estimation is spent regularly, and then, in percentage we will see degree of performance of the standards selected for given object.

The mechanism of interaction of components of a control system of quality of medical aid at accreditation of the medical organizations

Accreditation of objects of public health services becomes the indicative and complex mechanism of interaction and functioning of a three-componental control system by quality in public health services. Principles of display of interest and the initiative from the medical organizations, to formation of service of intrahospital audit, and also interest of the non-governmental organizations to formation of service of an independent expert appraisal should become an important point in the approach to formation of a three-componental control system by quality. For today there is traditional "warp" towards strengthening only state control. In public health services sector in 2005г. There was контрольно the supervising body, which purpose a quality assurance of medical services. For the past 2 years from the moment of creation of Committee of advancements in the field of development and introduction everywhere two other components of quality management weren't. In the separate organizations there are services or the separate actions which are bearing a faint resemblance to an intrahospital control system by quality are carried out. As to independent medical examination, we will notice that from party NPO the great interest to independent expert appraisal realization is shown, however in the absence of accreditation of independent medical experts anybody in territory RK doesn't have possibility actively to develop examination.

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Drawing 5. Model of interaction of components of system

Coming back to creation of intrahospital quality assurance it is necessary to allocate what intrahospital level of quality management should become leaders in model of three-componental system, and to occupy the basic niche of control, self-checking and quality management.

The three-level control system of quality doesn't reflect to the full an essence and a role of separate components of a control system of quality. To allocate two levels of quality management it is external examination presented by the state control and independent medical examination and an intrahospital control system of quality more correctly. The processes occurring in public health services, don't pass three levels of examination, they are divided and for each component of a control system quality defines the functions which aren't duplicated.

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