Researcher of the Department of Metrology Standardization and management quality of product Andijan Machine Building institute, Uzbekistan, Andijan
QUALITY MANAGEMENT SYSTEMS IN HEALTHCARE: MYTHS AND REALITY
This article describes the author's approach to understanding the quality management system (QMS) in health care and its major elements. It analyses the most common problems arising out of the QMS introduction into medical organizations (MO), dissects the key mechanisms of QMS: application of quality and risk management indicators. The clinical case shows how QMS elements can be used in practice. The authors express their vision of the main trends in this direction, QMS difficulties most frequently encountered in MO, make an attempt to identify the success and failure factors in the QMS standards application in MO.
В статье описывается авторский подход к пониманию системы менеджмента качества (СМК) в здравоохранении и ее основных элементов. Проанализированы наиболее распространенные проблемы, возникающие при внедрении СМК в медицинские организации (МО), проанализированы ключевые механизмы СМК: применение показателей качества и управления рисками. Клинический случай показывает, как элементы СМК могут быть использованы на практике. Авторы выражают свое видение основных тенденций в этом направлении, трудностей СМК, наиболее часто встречающихся в МО, делают попытку выявить факторы успеха и неудачи при применении стандартов СМК в МО.
Keywords: QMS, ISO, risk management, quality indicators, medical organizations.
Ключевые слова: СМК, ИСО, риск-менеджмент, показатели качества, медицинские организации.
Quality management has been and remains one of the frequently discussed and debated areas of scientific and practical activity, including in the field of health care.
In accordance with the State Program "Development of Health Care in the Republic of Uzbekistan", 95% of Uzbek medical organizations (MO) by 2024 should have a functioning health care quality management system.
Many MOs of the Republic of Uzbekistan apply various standards and recommendations to improve quality management systems. The most common quality management systems (QMS) based on ISO 9001: 2008, a new version of this standard, ISO 9001: 2015, is gaining popularity. There are organizations that are trying to use elements of the JCI standards, but such projects are rare due to the rather high cost and methodological difficulties that they face when implementing these requirements without adapting to Russian realities.
A year ago, an attempt was made to form a national quality management system in health care. FSBI "Center for Monitoring and Clinical and Economic Expertise" of the Federal Service for Surveillance in Healthcare on the organization of a system of internal quality control and safety of medical activities in a medical organization (hospital). Despite the narrowly differentiated name, in which only the term "quality control" appears, the analysis of these recommendations shows that the given methodological approach, in fact, is precisely the model of the QMS MO.
Among other things, there are many specialized standards and recommendations dedicated to various areas of MO quality management. Of the most common, ISO 15189 “Medical laboratories. Requirements for quality and competence "ISO 22870" Investigations at the point of care. Requirements for quality and competence and others. Thus, we can conclude that there is no lack of regulatory and recommendatory documents on the QMS of the Ministry of Defense. At the same time, a number of errors are observed when integrating various standards into the existing quality management systems of medical organizations.
- The term "quality management system" is perceived as a kind of documentary bureaucratic system, "superstructure" over real activities, especially on the part of the top management of the Ministry of Defense.
- There is a widespread belief that the QMS and the economic factors of the MoD are not related to each other. Accordingly, the personnel responsible for the QMS usually work in complete isolation from the full-time economists of a particular organization.
- Often, QMS is understood as the need to obtain a document confirming the compliance of the Ministry of Defense with a certain standard in a short time (most often it is about ISO 9001).
- Attempts to apply QMS standards in isolation from the current legislation. This happens more often in situations where an organization seeks to obtain ISO 9001 certification within a short timeframe and hires a third-party consultant on this standard who does not have adequate knowledge of the legal framework in the healthcare sector.
- Distancing the top management of the Ministry of Defense from work on the QMS.
- A purely technical perception of standards, lack of due attention to personnel management issues (especially with regard to motivation and involvement) when applying QMS standards.
The mistakes described above often lead to a complete failure of attempts to apply quality management standards in the practice of MO.
The question often arises: is there a real benefit for IO from the application of QMS standards? And if it exists, then how can the QMS project be made successful and useful both for patients and for the Ministry of Health and its employees?
In order to answer this question, it is necessary to agree on the following main provisions and aspects:
- The quality management system always exists, regardless of whether the MO applies any formalized QMS standards. The question in this case is different: what standards does it meet and how effective is it?
- The essence of all quality management standards is approximately the same.
In simple terms, the quality management system is how the work of each and every employee of the Ministry of Defense is organized at his workplace and how their interaction is carried out.
The favorite term for quality management specialists is “process management”. Very often, the audit of the QMS of the Ministry of Defense reveals that such processes as innovation, risk management, personnel motivation, etc. are carried out chaotically. In other words, they are outside the limits of systematic management. The purpose of applying QMS standards is to make 100% of the processes and the work of MO is manageable and standardized. But what does this mean in practice? Consider the elements of the QMS that can be described as the “central nervous system” of quality management: quality indicators, internal audits, risk management, nonconformity management, root cause identification and improvement.
1. Quality indicators
Quality indicators (or performance criteria) should be established for each process and monitored on an ongoing basis. Determining which indicators should be used is a very difficult task.
For example, only for a medical laboratory there are models with about 60 indicators. A comprehensive model that allows identifying such indicators for medical institutions as a whole is presented in the "Proposals (Practical Recommendations) for the organization of internal quality control and safety of medical activities in the medical institution (hospital)". The choice of quality indicators also presupposes the unification of methods for their assessment, the presence of a certain frequency, etc., which allows not only to manage the processes in one MO, but also to compare the activities of different MOs with each other, identifying areas of possible improvement. Thus, the principle of standardization is no longer applied at the institutional, but at the regional and other levels. The translation of information on quality indicators into the Six Sigma scale makes it easy to compare the achieved quality indicators both within and between different MOs.
2. Risks and inconsistencies.
Working with quality indicators is closely related to risk management. For each ML process, it is useful to highlight the stages at which errors and unwanted events can occur. It is necessary to have a list of possible undesirable events and record them. To do this, workplaces should have forms for recording an undesirable event (in paper form or as a module of a medical information system - MIS). Field staff should record and conduct an initial analysis of nonconformities, take urgent action (if necessary) and transmit information about the incident to a single center for processing nonconformities and risk management (this may be a department or quality service).
Analysis of the causes of nonconformities
The centralization of the management of inconsistencies (undesirable events) is necessary, among other things, for maintaining general statistics and tracking dynamics for different processes and departments of the Ministry of Defense, as well as analyzing the root causes of possible failures in work. One of the simplest tools for such analysis is the so-called “five whys” method, which, unfortunately, is often used incorrectly.
Let's give a simple example of such an analysis. Primary Issue Identified: New bedside diagnostic device produces many false positives. Let us show how in this situation the “five whys” method can be used (Table 1).
An example of the application of the method "Five" Whys ""
Searching for a reason
New POCD produces many false positives results
Why is this happening?
Temporarily stop using the device
Patients do not fulfill the conditions of preparation for
Why is this happening?
In the future, do not use this type of device in case of violation of preparation
Analyze the impact of training disruptions on results
Analyze the availability of instructions for patients, their accessibility for understanding
The staff did not focus the attention of the patients, did not monitored the implementation of the training rules
Why is this happening?
Develop a procedure for informing patients and monitoring compliance with the rules
Staff were unaware of the specifics of this POCD
1) Who is working with POCD and needs to know?
2) Conduct training with the involvement of the supplier
The supplier was not asked for information
Request information from the supplier
No POCD entry procedure
Design a procedure
Please note that the application of this method implies the development and implementation of an action plan for each stage. To implement such a system for managing undesirable events, it is useful to develop in detail a standard operating procedure (SOP), where a complete list of all possible undesirable events will be clearly spelled out (which is updated and updated as necessary), containing forms for recording and processing data and regulating personnel actions.
In its simplest form, such a form can have the following format (Table 2).
An example of an unwanted event recording sheet
Date of incident:
Brief description of the situation:
Submitted to the quality service (date, time, name,)
3. Internal audits.
Most often, internal audits are understood as either quality control and examination of medical care, or formalized audits for compliance with the requirements of ISO 9001. In the first case, internal audits are organized exclusively in accordance with the current legislation, in the second - in strict formal compliance with the recommendations of ISO 19011: 2011 "Guidelines for auditing management systems." Both approaches seem to be extremely ineffective from a practical point of view. Internal audit is, first of all, a management tool. The most powerful auxiliary tools for such self-testing, in the opinion of the authors, are: photographs of the working day , analysis of flows, performance of test tasks by employees, etc. Naturally, traditional methods are also very useful (analysis of documents and records, observation of work etc.). For the most effective organization of internal audits, it makes sense to begin with describing and analyzing all the elements of self-reviews that are performed in the MO: how systematic the work is, what methods are used, etc. If the organization already has a QMS, it is advisable to involve economists to analyze the cost average internal audit and compare with the effect of those decisions that are made on the basis of its implementation.
Improvements: it is impossible to improve what cannot be measured.
Information on quality indicators, risk assessment, and internal audit data should be used by the MO management to make decisions on which processes and procedures require immediate improvement (changes), which should be improved in the near and long term. Together with data on the functioning of the organization's external environment (the analysis of which is also part of the QMS), this information is necessary to draw up plans for strategic development and tactical tasks, which can be detailed down to departments and employees. The skeleton of the QMS MO is the basic principles of quality management, which are defined in different ways in different standards, but are essentially the same. First of all, this is focus on the patient and other consumers of services, staff involvement and motivation system, active participation of top management, leadership positions of managers, approach to the organization as a system of interacting and mutually influencing elements, management of interactions with suppliers, contractors and others. "Outside" parties, etc. "Muscles" of the QMS MO are key medical and auxiliary processes. A list of them can be compiled by examining the standards for health care. Examples of such processes can be:
• processes of identification of the patient's personality;
• system for ensuring epidemiological safety;
• drug safety;
• surgical safety and prevention of risks associated with surgical intervention;
• prevention of risks associated with transfusion of donor blood and its components;
• prevention of bedsores and falls of patients;
• managing the safety of persons with disabilities.
The following auxiliary processes can be distinguished:
- Equipment management, including facilities
- Personal data management
- Security management;
Once again, let's return to the question of the QMS documentation. Why do we need all these papers and notes at all? We will leave the documents and records that are required by law outside the scope of this review. Let's concentrate on the documents that arise in the process of building a QMS based on any standard. It is to these "additional" papers and records that the employees of the Ministry of Defense, where the QMS are being implemented, often make many claims. What are these documents for?
In the framework of this review, we have touched on only the very basics of the QMS MO. Not all approaches to quality management in the health care sector have been described, and only a small part of the elements of the QMS MO. Our goal was to demonstrate that QMS is an integral part of the MoD's activities, focused on achieving practical results: improving the quality of medical care and ensuring the safety of patients and staff, taking into account available resources and constraints. The important thing is that whatever standard is applied in a particular organization, in itself it is only a tool, not a goal. To build an effective QMS, the requirements of many standards should be applied for each process in the IO, and not "pull" real activities to the requirements of ISO 9001 or other similar systems.
- Kurylev V.A. Experience in organizing a quality management system in an emergency hospital. - Deputy Chief Physician. - 2015. - No. 2 (105). - S. 26-38.
- Ivanov G.A. Internal audits as a management tool. Photo of the working day. // G.A. Ivanov, S.V. Sommer, A.V. Emanuel et al. // Quality management in health care. - No. 4, 2015. - S. 24-31.
- Emanuel A.V., Kalenskaya A.V., Ivanov G.A. etc. Development of documentation for the quality management system of a medical laboratory based on the requirements of ISO standards. - Medical almanac, No. 4. - 2016.
- A.A. Abduvaliev, V.B. Latipov, A.S. Umarov, M.N. Alimov, O.Sh. Hakimov, V.I. Khvan "Standardization, metrology, certification, quality" Tashkent 2018
- Aruna Ranavira, Medical Device Risk Management: A Case Study and Challenges, San Francisco, California, October 2, 2012;
- World Health Organization Medical Devices Regulations Geneva 2013.
- Электронный ресурс www.standart.uz.