The problem of health care services quality improvement and the reduction of the corresponding risks remain relevant and controversial issues in the U.S., even after the introduction of the healthcare reform. It is estimated that at least 30-50% of health care costs in the country account for low-quality medical services. The evaluation of the direct costs of poor-quality medical care is approximately 1200-2500 dollars for every American (Sollecito & Johnson, 2013). In the developed countries, including the U.S., the healthcare delivery systems use a variety of technologies and techniques to deal with such shortcomings, which are united under the names of the quality and risk management.

Currently, the methodology for quality management of medical care is recognized as the best methodical base to improve the quality of the healthcare delivery systems in most countries. In particular, the World Health Organization has issued a document that examines the experience of the different countries in terms of quality and risk management systems establishment (Sollecito & Johnson, 2013). It can be used as a basis for the quality management at almost any healthcare delivery system. However, the efficiency of all the proposed measures will be low in case the appropriate strategies for the quality and risk management are not selected. Therefore, the following research is dedicated to the selection of the strategies that will guide the processes of risk and quality management in the healthcare delivery system.

Quality Management Strategy

By taking into account the specifics of the healthcare delivery system, it is possible to distinguish the three models of the quality assurance processes management – professional, bureaucratic, and industrial.

The professional model has been historically developed as a form of quality management at the level of a single healthcare facility. In such case, the quality criterion is based on the individual professional level of a healthcare specialist. However, being based only on the intuitive thinking of a physician, the model proved to be not efficient in terms of providing high-tech types of medical care. The reason for that is the fact that they require the coordinated involvement of a large number of professionals and the improvement of the medical work in general. Such model does not take into account the economic component of the quality and evaluation is performed by the attending physicians. As a result, the assessment of the treatment quality is done only considering the professional expertise (Beck & Melo, 2014).

The bureaucratic management model is based on the principle of the work amount standardization and the results of medical care. As a result, the control system is based on the orders, instructions, and methodology of ubiquitous monitoring. At the same time, it has inherited the of professional management model features. Undoubtedly, the introduction of a bureaucratic model based on the standardization of volumes and outcomes of care is a progressive step in the work of improving the quality of care. However, it does not involve the participation of the auxiliary and utility services of medical institutions, health authorities, and the ordinary medical workers. In such cases, the issues of care quality are handled by the representatives of the administration and heads of medical diagnostic units. As a result, the overall level of quality depends on their correct interaction (Beck & Melo, 2014).

The industrial model is primarily based on Deming’s quality model, which is centered on three main principles: the process approach, the continuous quality improvement, and the participation all the workers of the system in the process of quality management. The principle of continuous care quality improvement has become an important component of the modern management theory, which states that quality is created through the use of high-quality processes, materials, and tools. For the achievement of the best results, it is required to focus not on the verification of the individual performance but the management of processes, detecting deviations, and analyzing their causes. Such approach provides the achievement of clinical outcomes, allows keeping the cost of healthcare services within rational boundaries, increases the degree of satisfaction of medical personnel with their work, and assures that the patients are satisfied with the received medical treatment (Beck & Melo, 2014).

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It should be noted that due to the existence of numerous negative system factors (legal, financial, organizational), it is an optimal model based on combination of individual elements of the three known control systems of care quality – professional, bureaucratic, and industrial. They must be united by the common strategy – the continuous improvement of the healthcare delivery system quality (Ross, 2013).

As a strategy, the continuous improvement of the healthcare services quality focuses its attention on several key management functions. The first of them is the assurance of the quality level (the degree of satisfaction of needs) that is both expected and achievable at the present stage of healthcare development. The next function is the improvement of diagnostics and treatment processes in case their quality is unsatisfactory or the maintenance of the achieved levels of quality – in other words, the quality control. Moreover, it also focuses on the continuous decline in prices for medical services due to the faultless operation of the entire healthcare delivery system. Finally, its primary focus is the active involvement of all employees in the process of quality control and the efficient use of their knowledge to conduct the guidance through specific positive or negative examples. The primary measures of the continuous quality improvement strategy are the social, medical, and economic results and, of course, customer satisfaction (Sollecito & Johnson, 2013).

The creation and development of quality management systems of medical care through the use of modern management concepts is an important task. The primary reason for that is the fact that the organizational structure of quality management within the healthcare delivery system is one of the conditions for ensuring the citizens’ right to medical aid. Moreover, it allows solving the problems related to the sub-optimal use of financial resources for the improvement of the material and technical base and personnel training (McLaughlin et al., 2012).

The process of implementation of the continuous quality improvement strategy consists of several stages. The first of them is the initiative (explanatory) stage. During it, the managers explain the basic principles of the continuous quality improvement to the staff and discuss the goals and objectives for the specific areas of work. As a result, the employees are being introduced to the issues of the continuous quality improvement strategy, such as the choice of goals and objectives to improve the quality, performance and quality assessment, the identification and analysis of the problems and the ways to resolve them, as well as the choice of the methods and forms of control (Sollecito & Johnson, 2013).

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The next stage is dedicated to planning. The employees of various units of the healthcare delivery system offer the proposals for a basic plan for their departments and organizations, as well as the individual plans. Later, all the proposed plans are summarized to create a master plan for the quality improvement. It is coordinated with the production plans of the system – the management of the healthcare facilities determines the priority issues, performance assessment, working methods, deadlines, and the people responsible for the implementation of a plan (McLaughlin et al., 2012).

The planning stage is followed by the implementation phase. During it, the staff of health facilities performs the activities aimed at the resolution of the problem and its causes in accordance with the plans. The managers monitor the processes (McLaughlin et al., 2012).

The next phase is dedicated to control – the management summarizes and evaluates the efforts to improve quality and defines whether the goal was achieved. Accordingly, the following actions depend on the results of such evaluation (Sollecito & Johnson, 2013).

Thus, the strategy of the continuous quality improvement implies the presence of systematically planned and performed actions aimed at provision of the highest consumer properties for each type of the provided services and performed tasks. The quality management system is cyclical – at the beginning of each cycle, the ability to satisfy the customer’s expectations is assessed. On the basis of the results of such evaluation, the new changes in the resources and technologies of the healthcare delivery system are planned. As a result, the system of monitoring of the consumers preferences emerges. The identification of deviations from the standards and the analysis of the reasons for such deviations are performed.

In addition, the most prominent workers are being encouraged, resulting in the creation of positive motivation. It is meant to replace the negative motivation, which is common for the majority of quality control systems (Lighter, 2011). In particular, the identification of deviations from the specified quality parameters is usually punished administratively or economically. The most important element of the strategy of continuous quality improvement is the ubiquitous process of taking measures to improve the efficiency of the healthcare delivery system. The Deming cycle (Plan – Do – Check – Act) works in healthcare as effectively as in the other industries. In particular, the improvement of the healthcare services quality reduces the costs and losses of the system as a whole (McLaughlin et al., 2012).

Risk Management Strategy

The development and introduction of a risk management system allows identifying and assessing the impacts of risks, as well as developing a strategy to counter them is one of the ways to improve the quality of the healthcare delivery system.

It should be noted that in the condition of the continuous improvement of the provided services quality, the healthcare professionals often develop a subjective sense of safety – the so-called imaginary prosperity. The primary reason for that is the fact that the majority of incidents in health institutions at all levels of the healthcare delivery system ends favorably due to the abovementioned strategy of the continuous quality improvement. As a result, no harm is done to the staff and the patients. Only a small proportion of cases results in significant harm to the health of the people and even their death. In such situation, there is no clear causal link between the defects of the staff, the organization of their work, and the occurrence of damage to the health of patients. The low incidence of severe outcomes is the primary reason for the staff not to be aware of the risks that may hinder the process of healthcare services delivery. As a result, healthcare professionals continue making the same mistakes, which does not contribute to the prevention of defects in the delivery of medical services (Carroll & Nakamura, 2011).

The concept of risk management is aimed at development of stability of the health care delivery system to incidents, accidents, and losses. It allows revealing the abovementioned hidden hazards and developing the efficient countermeasures. In particular, in their activities, the healthcare professionals are constantly faced with the risk of adverse reactions to drugs, complications of the diseases, and the other adverse outcomes. Any risk has the two primary characteristics – the probability and the damage it causes. For example, the risk of receiving an injury is high but the average damage caused by it is usually equivalent to temporary disability. At the same time, the risk of anaphylactic shock in response to the administration of a particular drug is small but the damage it causes is high. In particular, it may be fatal for the patient (Heyman et al., 2010).

Risks can be associated with the process of healthcare, being diagnostic (risks of incorrect diagnosis, the defects of information exchange, etc.), medical (surgical risks, the risks of drug therapy, the risks of interaction between specialists and the continuity of care, the risk of complications and adverse drug reactions), and those connected with the hospital stay (the occurrence of undesirable events).

Risks of the auxiliary processes may be financial (the lack of funds, failure to provide reports on time), the ones related to the supply of material resources (the lack of necessary medicine and power outages), the nutrition of the patients (low-quality food, food poisoning), cleaning of the establishments (substandard cleaning, the occurrence of nosocomial infections), etc. As a rule, the occurrence of any of such risks is possible through a sequence of steps, which is called a script. At each step, the process of a random event development can stop or continue. By knowing the likelihood of events at each step, it is possible to calculate the possibility of risk as a whole (Kavaler & Alexander, 2014).

The essence of risk management is to create a complex of measures within the healthcare delivery system to counter the mentioned risks. It is necessary to distinguish the two approaches to risk management: people-oriented and systemic (organizational). The people-oriented approach focuses on the individual errors related to forgetfulness, incompetence, negligence or immorality of the staff. The organizational approach focuses on conditions in which people work and is based on developing a protection system that prevents errors and compensates for their consequences (Tweedy, 2014).

By taking into account the provided information, as well as the fact that the strategy of continuous improvement has been selected to guide the process of quality management, it is possible to propose the efficient strategy of risk management for the healthcare delivery system. It consists of five following steps (Kavaler & Alexander, 2014):

  • The identification of threats and hazards;
  • The evaluation and definition of anything that can be damaged;
  • Risk assessment and decision-making regarding the necessary precautions;
  • The documenting and implementation of the countermeasures;
  • The revision of the risk management system with its following renewal.

The identification of threats and dangers may be performed in various ways. It is possible to conduct an audit of the healthcare delivery system, up to the visual inspection of all workplaces. The results of the inspection can be used to create the initial plan of threats. The information from the staff and patients can be obtained through surveys or questionnaires. Some information about possible threats can be derived from clinical guidelines, articles, and manuals. The instructions for medicines, as well as the manuals for various medical devices, may also serve as the source of information.

Moreover, the data on the potential threats can be obtained from the framework for reporting the incidents. The analysis of the various incidents results in the healthcare delivery system must be reviewed compulsorily and included in the system of risk assessment. It should be taken into account that there are also the implicit risks that are delayed in time or are not considered important from the subjective point of view. Such factors may include high noise levels, poor lighting, poor ventilation, the lack of awareness of the staff, and the imperfect system of visual signs. The consequences of such risk factors are often delayed, resulting in a subjective underestimation of the threats they may present for the healthcare delivery system (Youngberg, 2011).

During the process of data collecting, it is necessary to identify the elements of the system that may be affected by the risks. In particular, in the healthcare industry, any threat is directed against a particular group of people. Therefore, such group should be allocated. Considering the fact that the undesirable events may be different, it is necessary to understand the scenario of their development, as well as their type, and the magnitude of potential damage they may cause. As a rule, in order to identify the risk, the approach based on analysis of experts’ opinions or working group is used. During the assessment phase, it is required to identify the two quantitative parameters: the probability and the size of possible damage. Certain categories of patients may be analyzed and viewed separately from the other groups. They include the people with different levels of disability, those suffering from the loss of coordination, lack of limbs, etc. (Tweedy, 2014).

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Once the risks, their probability, and the magnitude of harm are identified, it is necessary to proceed to the step focused on the development of methods to minimize the risk. The choice of risk management method depends on the efforts that are required to minimize the potential damage. As a result, various management approaches can be reviewed. By the nature of their impact, such approaches can be divided into the reductive (minimizing the probability and damage) and the retentive ones (providing guarantees or insurance). In medical practice, the reduction of the risk by minimizing the probability of its occurrence can be performed in several cases. The first of them is the introduction of additional control systems (for example, the process of the prescription of drugs is monitored by a pharmacist and clinical pharmacologist).

It can also take place during the identification of the trigger events (delays in hospitalization, old age), and the use of less risky technologies (minimally invasive surgery). Moreover, its performance is required during the prevention of access to potentially dangerous objects and places (the use of fences and the introduction of the access control systems), and the restructuring of the processes that occur in the system to ensure the impossibility of the particular scenario of risk development. Finally, it is involved in the use of protective equipment, such as masks, goggles, special shoes, and the provision of the first aid kits and disinfectants to remove bacteria. Harm reduction can be also achieved through the use of early warning systems, personnel training, etc. On the other hand, the retention of risk can be accomplished through the creation of an additional reserve of drugs, as well as the additional grid connection.

Risk transfer can be carried out on the basis of the insurance of liability, as well as the medical equipment and material losses in the health insurance organizations. An important element of risk management is to assign the number of managerial staff of the healthcare delivery system that is responsible for the risks. In addition, the revision of the system is determined by the frequency of risk (Heyman et al., 2010).

The documentation collection and implementation of the measures for risk management are also the important tasks. All the risks that were identified must be fixed in the documents and distributed among the employees of the system. As a rule, such work results in a large number of comments and suggestions from the side of the staff. However, it is better not to implement all of the proposed projects and execute all changes immediately. It is necessary to develop a phased plan for the implementation of all the proposed improvements (Youngberg, 2011).

The final stage of the risk management strategy is the revision of the system. In the modern conditions, the healthcare delivery system cannot be viewed as a fixed object. The requirements for it are constantly changing, the new technologies are being implemented, and the new equipment is commissioned to it. Accordingly, the risk management system must be constantly reviewed to comply with the structure of the healthcare delivery system, its staff, and the processes that occur within it. In other words, the risk management system must be continuously improved, which corresponds to the abovementioned quality management strategy (Carroll & Nakamura, 2011).

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The ongoing process of modernization in the field of public health, namely the healthcare reform of 2010, dictated the need to review the concept of quality and risk management in the field of medical and pharmaceutical care by selecting the new, appropriate strategies that would guide the processes. In this regard, the strategy of the continuous quality improvement seems to be the most optimal for the quality management in the healthcare delivery system. It is focused on several following principles. The first of them is the focus of all management activities in the healthcare system on the quality of medical services and medical supplies. The participation of the staff of all departments of medical and industrial organizations at all levels of their organizational structures to manage the quality of medical care is also required. Moreover, the creation of a material system and moral incentives for the members of labor collectives of the organizations to maintain their interest in providing the high quality of their products (services) is absolutely necessary.

Thus, in the broad sense, the primary task of the continuous quality improvement in the healthcare delivery system is to create and sustain the ethical and deontological culture within the healthcare organizations that is focused primarily on the provision of the high-quality medical services and medical supplies. In an effort to achieve the fullest satisfaction of the consumer demands, which have increased dramatically in recent years, each employee must monitor and improve the process of his/her work independently and systematically.

The strategy of risk management is subordinate to quality management, since the low level of risk is intertwined with the high quality of services. At the same time, during its development, it is necessary to consider the role of safety culture in the process of medical errors prevention. The safety culture is the result of individual and group attitudes, perceptions, knowledge, and patterns of behavior that define the style and skills of risk management in the organization. In case it will be established, thus, replacing the sense of the imaginary prosperity, such measures of risk management as data collection, analysis and assessment of risks, and the development of the countermeasures will be much easier to perform.

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