: pp.30-38
State Enterprise "Lviv Scientific and Production Center for Standardization, Metrology and Certification" (Lvivstandardmetrology State Enterprise)
Lviv Polytechnic National University

Adopting socially responsible management practices of the organization promotes greater awareness in decision-making, based on a better understanding of society's expectations, anticipation of risks, and opportunities. Responsible management of an organization can improve its relationships with stakeholders. Encouraging compliance with regulatory obligations leads to decisions that are more likely to gain the support and trust of those who implement them and who they influence. The result can be improved risk management practices and improved reputation.

The concept of "risk" today has a fairly broad meaning and is used in completely different contexts. Synonyms of risk can be such concepts as "danger", "threat", "trouble", etc. However, in many definitions of risk in the scientific literature, this term is used in a special sense, where risk is associated primarily with the concept of uncertainty. Therefore, the risk is understood as uncertainty, which can result in one or another adverse event. Clinical risks - risks that arise directly from the provision of medical care. These include clinical errors and negligence, infections in medical care, and non-consent.

The principles of risk management and the need to use them are effectively applied in many areas of economic activity and public administration, including health care, as well as institutions that provide regulatory activities in these areas, including clinical diagnostic laboratories. Today, prevention as management of patient quality of health has become a dominant part of medicine, where laboratory diagnostics, which can detect the risks of many diseases, is not the least important. The presence in the health care system of only certain fragments of activity risk necessitates the formation of an overwhelming majority of an effective integrated risk management system, which must comply with certain requirements and principles: determining the characteristics of the system; optimization of the risk management model of medical structures; substantiation of prerequisites for the introduction of a comprehensive medical risk management system and evaluation of the effectiveness of its operation.

[1] M. Abdi, “Standardization as a tool for creating a quality assurance for laboratory research”, Coll. Sc works of taff of NMAPE named after PL. Thug, Issue 2, 2014, pp. 514 - 521.

[2] G. Ivanov, "Methodological aspects of the implementation of quality systems in the field of laboratory medicine", Clinical laboratory diagnostics, Issue 5, 2011, pp.54-56.

[3] E. Zaremba, O. Yastremskaya, "The Value of Laboratory Medicine in the Practice of Family Doctor at the Stage of Primary Health Care Reform", Family Medicine, Issue.1, Vol. 75, 2018, pp. 47-49.


[4] C. Campbell, A. Horvath, “Harmonization of critical result management in laboratory medicine”, Clin. Chem. Acta, Vol.432, 2014, pp.135-147.


[5] G. Lippi, G. Guidi, “Risk management in the preanalytical phase of laboratory testing”, Clin. Chem. and Lab. Medicine, Vol.45, Issue 6, 2007, pp.720–727.


[6] I. Sydorko, R. Baіtsar, “Normative and metrological providing of clinical-diagnostic laboratories”, Measuring equipment and metrology,  Vol.79, Issue .3, 2018, pp.49-54.


[7] I. Sydorko, R. Baitsar, A. Petrukh, “Standards of Social Responsibility in Clinical and Diagnostic Laboratories”, Measuring Engineering and Metrology, Vol. 80, Issue 4, 2019, pp.9-15.


[8] V. Protsenko, "Fundamentals of Quality Assurance in Clinical Laboratory Research", A Manual for Doctors, Kharkiv, Ukraine, 2009, pp.115-119.

[9]. Y. Sergeev, S. Yerofeev, “Adverse outcome of medical care”, Moscow, RF, 2001, p.288.

[10] M. Plebani, “The detection and prevention of errors in laboratory medicine”, Analiz of Clin. Biochemistry, Issue. 47, 2009, pp.101-110.


[11]. ISO 31000:2018 Risk Management. Principles and guidelines. (ISO 31000: 2018, IDT).

[12]. V. Tichenko, N. Tichenko, "Improvement of the quality management system for the provision of services to medical laboratories on the basis of risk-oriented approach", Standardization, certification, quality, Issue 1 (113), 2019, pp.47-52.

[13] “Methodical recommendations on the organization of clinical management of risks and safety of medical care in security institutions”, Ministry of Health of Ukraine. Ukrainian Center for Scientific, Medical Information and patent licensing work,  Kyiv, 2012.

[14] T. Zawarza, "The Legal Importance of Risk to Civil Liability of Hospitals for Independent Treatment", Research Inst. Private Law and Entrepreneurship of the Nat. Ac. of Leg. Sc. of Ukraine, Kharkiv, 2013, pp 1 – 11..

[15] K. Kohn, J. Corrigan, M. Donaldson, “To Err Is Human: building a safer health system», Washington, DC: National Academy Press, 1999.

[16] M. Plebani, "Identifying and preventing mistakes in laboratory medicine», Annals of Clin. Biochem., Issue 47, 2010, pp.101-110.


[17] ISO / TS 22367:2015 Medical laboratories. Reduce errors by risk management and continuous improvement.

[18] ISO EN ISO 15189:2015 Medical Laboratories. Requirements for quality and competence (EN ISO 15189:2012, IDT).

[19] I. Sydorko, R. Bajtsar, “Providing quality of clinical-diagnostic laboratory activity”, Measuring equipment and metrology, Vol.80, Issue 2, 2018, pp.66-73.


[20] G. Sirova, O. Levashova, T. Tishakova, “Risk Analysis in a Clinical Laboratory”. Kharkiv Nat. Med. Un., In Proc. of Sc.-Pract. Conf. with Participation of int. experts, "Topical Questions of Lab. Medicine", (Nov. 20-21, 2018), Issue 285, pp.89-90.