QUALITY MANAGEMENT IN PUBLIC HEALTH: ORGANIZATION, FUNCTIONING, RULES AND SOME RESULTS

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EUROPEAN JOURNAL OF ACCOUNTING, FINANCE & BUSINESS
Volume 12 / 2024 ISSN 2344-102X
Issue 2 / June 2024 ISSN-L 2344-102X
DOI: 10.4316/EJAFB.2024.12207 53
Oana MIRON
Valahia University, Str. Aleea Sinaia, No. 13, 30004 Targoviste, Romania
nicoricioana@yahoo.com
Abstract
The purpose of this paper is to highlight the most significant aspects of quality management in the public health
sector in Romania, with a particular focus on the organization, functioning, existing regulations, and outcomes
achieved to date in this area. Our motivation stems from the fact that adequate control and good quality assurance
in public health can significantly contribute to improving patient outcomes, reducing costs, and increasing trust
in the healthcare system. By implementing rigorous evaluation and improvement methods, health systems can
ensure better and safer care for all patients. Based on the most recent literature, we address issues such as the
establishment of the organization responsible for quality management in Romania's health sector (including the
national regulatory context and organizational form, as well as the main aims and objectives of this organization).
We then focus on the activities of the hospital accreditation office within the National Authority for Quality
Management in Health (NAQMH / ANMCS) and the exercise of specific competencies by the North-East
Territorial Office in Iași. The conclusion of our paper is dedicated to the most important findings regarding the
studied topic.
Keywords: Quality management; public health; hospital (or inpatient health facility/IHF); hospital accreditation;
accreditation categories.
JEL Classification: H51; I18
I. INTRODUCTION
Quality control and assurance in public health have recently gained significant importance due to the desire
to provide medical services that are as safe, efficient, and high-quality as possible. From a conceptual perspective,
quality in public health refers to the extent to which health services increase the likelihood of desired outcomes
for patients and are consistent with current professional knowledge (Boghian, 2021; Gheorghe, 2006; Chiru, 2006;
Armean, 2002). In the same vein, the Council of Europe Recommendation of September 30, 1997, states: "The
quality of health care is the degree to which the treatment provided increases the chances of the patient achieving
the desired outcomes and reduces the chances of undesirable outcomes, considering the current state of knowledge"
(https://rm.coe.int/).
Continuous and improving quality assurance requires that at certain intervals, specialized personnel apply
specific methods and use particular tools (Donabedian, 2005). These include: (i) clinical audits (a systematic
process of reviewing medical services to ensure they meet quality standards and identifying areas for
improvement), (ii) performance evaluation (using performance indicators to monitor and assess the quality of
medical services), and (iii) patient feedback, which involves collecting and analyzing patient opinions to
understand their experiences and identify opportunities for improvement. Additionally, ongoing training is
essential, aiming to ensure that medical personnel are up-to-date with the latest knowledge and practices through
continuous education and training programs (Enăchescu & Marcu, 1998).
In this context, Romania, like other European Union (EU) member states, has implemented a hospital
accreditation system, which involves periodic evaluation and certification of medical institutions according to
rigorous quality standards. In 2016, the first cycle of hospital accreditation was completed, initiated after 2011.
Based on accumulated experience, quality standards and accreditation methodology were reviewed and approved
in 2017.
Following changes in the approach to quality in the health system promoted at the governmental level (RG,
2015), the development of quality management in health accelerated, including the regionalization of monitoring
accredited health facilities and adverse events associated with medical procedures. These initiatives were further
reinforced by the adoption of a law (RP, 2017) concerning quality assurance in the health system.
The evolution of regulations in the quality of health services, reflected in amendments to Law No. 95/2006,
is as follows: (i) initially, quality assurance of health services was the responsibility of the National Health
QUALITY MANAGEMENT IN PUBLIC HEALTH: ORGANIZATION,
FUNCTIONING, RULES AND SOME RESULTS

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DOI: 10.4316/EJAFB.2024.12207 54
Insurance House (NHIH / CNAS), which accepted contracts only with authorized and evaluated providers
according to the law; (ii) CNAS / NHIH and the Ministry of Health were responsible for developing quality
evaluation criteria; (iii) in 2015, Law No. 126/2015 transferred this responsibility to the newly established National
Agency for Quality Management in Health (NAQMH / ANMCS) (RP, 2015); (iv) since the enactment of Law No.
126/2015, NAQMH / ANMCS is the only legally competent body to evaluate the quality of health services.
Our work aims to address problems of this nature ("Quality management in public health: Organization,
functioning, rules, and some results"), and is structured as follows: (1) Introduction; (2) Strategic coordinates
regarding quality in the public health sector; (3) Establishment of the body ensuring quality management in health
in Romania (3.1. National regulatory context; 3.2. National Agency for Quality Management in Health (NAQMH
/ ANMCS): Organizational structure, purpose, and main objectives; 3.3. Activity of the hospital accreditation
office within NAQMH / ANMCS (2022); (4) Findings in the competence area of NAQMH / ANMCS - North-
East Territorial Office in Iași; and (5) Conclusions.
In preparing this work, we have considered the most recent bibliographic resources, including reports from
prestigious institutions in the field, policy/strategy documents, and the legislative framework in force at the time
of completing this endeavor
II. STRATEGIC COORDINATES REGARDING QUALITY IN THE PUBLIC HEALTH SECTOR
In 2008, the National Hospital Accreditation Commission (Co.NAS) was established through a government
decision (RG, 2008), which defined its structure, responsibilities, and modes of organization and operation. The
primary objective of Co.NAS was to accredit hospitals in Romania to implement governmental health policies and
programs and to align national legislation with European standards, with the aim of continuously improving the
quality of hospital medical services (RG, 2018).
Currently, the National Agency for Quality Management in Health (NAQMH / ANMCS) is implementing
the National Quality Assurance Strategy for the Health System for the period 2018-2025, which focuses on specific
action areas and competencies, concentrating on several major directions (Table 1).
Table 1. Action areas and specific competencies
Source: National Quality Assurance Strategy for the Health System, 2018-2025
The implementation of the “Quality in Health” strategy is carried out through the Action Plan, which defines
the responsibilities and roles of healthcare professionals, ensuring the monitoring and evaluation of progress
toward achieving the set objectives for the medium term and by 2025. Specialists in the field, quality managers,
patients, and patient associations play a crucial role in this implementation. These groups, adhering to the values
of NAQMH / ANMCS, will understand and support the vision of "quality in health", thereby contributing to the
improvement of health services through quality, efficiency, and performance, ensuring patient safety and

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satisfaction for the patient, family, and community.
The implementation of the strategy is complemented by the development and application of subsequent
strategies that establish specific and complementary objectives. These provide the necessary support for achieving
NAQMH / ANMCS’s mission, aligning with the requirements of similar organizations in the European Union and
introducing performance and outcome indicators for the international recognition of NAQMH / ANMCS and its
standards. It is important to allocate adequate financial resources and ensure the efficient use of funds, particularly
public funds, to enhance health services (Bostan & Bostan, 2023ab; Bostan et al., 2022ab; Asalos et al., 2022).
Monitoring and evaluating performance in the implementation of the Strategy and Action Plan depend on:
(i) the quality and clarity of the indicators used; (ii) the structures involved in data collection and reporting; (iii)
the speed of response for completing missing or irrelevant information.
Developing a culture of quality within organizations implementing the strategy is essential for ensuring
objective feedback and assessment. Additionally, surveys, studies, and research, whether quantitative or
qualitative, can be used to evaluate the results of the strategic measures applied in healthcare facilities.The
indicators included in the Action Plan will be monitored throughout the strategy's implementation. Their progress
will be analyzed annually and during stage evaluations, with final conclusions being formulated in the 2026
assessment.
III. CREATION OF THE ORGANIZATION RESPONSIBLE FOR QUALITY MANAGEMENT IN
THE HEALTH SECTOR IN ROMANIA
In the field of health quality and its management, NAQMH / ANMCS collaborates with other national
bodies, including the Ministry of Health, the National Health Insurance House, the Health Insurance House of the
Ministry of Defense, and at the county level or in the municipality of Bucharest, with the Health Insurance Houses
and Public Health Directorates.
Given the subject of our paper, we will focus specifically on the role of NAQMH / ANMCS. According to
Law No. 95/2006 on health reform and Law No. 185/2017 on ensuring quality in the health system, NAQMH /
ANMCS is nationally responsible for establishing quality standards for healthcare facilities, evaluating and
accrediting them, as well as developing the regulatory framework in the field of health quality. Article 249 (1) of
Law No. 95/2006 states that "the evaluation of the quality of health services for the purpose of accrediting
healthcare units falls to the National Authority for Quality Management in Health" and according to Article 249
(2), "the evaluation and accreditation of healthcare units are carried out based on the standards, procedures, and
methodology developed by the National Authority for Quality Management in Health" (RP, 2006).
It is important to note that "evaluation represents the process through which a commission of independent,
specially trained, and accredited evaluators checks the conformity of processes within the healthcare unit with the
requirements of the standards" (ANMCS, 2018). This process includes three main stages (Table 2).
Table 2. The stages of the evaluation process
Source: ANMCS, 2018
Evaluators focus on determining whether quality management is fully understood and accepted by the
leaders and staff of the structures, whether there is a genuine concern for quality, and whether procedures and
protocols are designed to address identified issues (ANMCS, 2018).
Additionally, it is essential for the evaluation team to verify whether the unit has a self-assessment system
intended for the continuous improvement of its activities. Following the identification of non-conformities, the
evaluators must work with the management of the healthcare unit to develop a compliance plan.
3.1. National regulatory context
Accreditation is an essential requirement for all healthcare facilities, whether they provide services within

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the public health insurance system or not, with the exception of family medicine practices, dental practices, and
specialized outpatient units regulated by Government Ordinance no. 124/1998 (RG, 1998). This requirement does
not apply to pharmaceutical units, such as pharmacies and open circuit drugstores.
Previously, regulations regarding the quality of healthcare services were scattered across various normative
acts with variable legal force, and until 2017, these norms were only partially complete, sometimes contradictory,
or redundant. Some of these shortcomings were due to the introduction of new provisions without the repeal of
previous regulations, leading to implementation difficulties and repeated legislative corrections.
In this context, Law no. 185/2017 on ensuring quality in the healthcare system (RP, 2017) was adopted.
The law establishes that the responsibility for ensuring the quality of healthcare services and patient safety lies
with healthcare facilities, according to the policies and strategies promoted by the Ministry of Health and the
National Authority for Quality Management in Health (NAQMH / ANMCS). According to the law, the
standardization and evaluation of healthcare services are carried out by NAQMH / ANMCS, and its regulations
are mandatory for healthcare facilities seeking accreditation.
Subsequently, new amendments were introduced to clarify the obligations of healthcare facilities in the
domain of healthcare service quality. These amendments aimed to clarify the general applicability of provisions
regarding healthcare service quality and to define more clearly the obligations of healthcare facilities, regardless
of their funding source. Additionally, the obligations of public authorities for monitoring and controlling
compliance with these obligations and the methods for performing quality control were established.
Furthermore, the amendments improved the regulation of staffing requirements by setting criteria for
determining staff needs and ensuring the continuity of medical activities under conditions of patient safety.
Measures were also introduced for the periodic analysis of human resource utilization and flexible use of staff to
maintain the continuity of medical and patient care services.
3.2. National Authority for Quality Management in Health (NAQMH / ANMCS): Organizational
structure, purpose, and main objectives
NAQMH / ANMCS is a public institution with legal personality, operating as a specialized body within the
central public administration, with the primary responsibility of managing quality in the healthcare sector. Directly
subordinate to the Government and coordinated by the Prime Minister, the agency’s governance structure includes
the Board of Directors, its Permanent Office, the President of NAQMH / ANMCS, and the General Director (RP,
2017). The agency plays a crucial role in the standardization and objective evaluation of healthcare services, with
its central responsibility being the accreditation and monitoring of healthcare facilities (Bostan & Grosu, 2010).
Its independence from all involved parties ensures the impartiality of the evaluation process. The agency is funded
by its own resources, supplemented by subsidies allocated through the budget of the General Secretariat of the
Government.
The main purpose of NAQMH / ANMCS is to ensure and continuously improve the quality of healthcare
services and patient safety by establishing rigorous standards and conducting ongoing evaluations of healthcare
facilities (ANMCS, 2023). Additionally, NAQMH / ANMCS is tasked with identifying dysfunctions in the
healthcare system, analyzing their causes, and proposing solutions to the competent institutions.
The key objectives of NAQMH / ANMCS include (ANMCS, 2023): (i) systematic evaluation of the quality
of medical services and patient safety across all healthcare facilities (with the results map presented in Figure 1);
(ii) development of an effective methodology for identifying, analyzing, and reporting adverse events in medical
care in a non-punitive manner, with the aim of collecting relevant national data; (iii) continuous training and
information for staff responsible for quality management in health; (iv) ongoing professional development in
quality management and patient safety for healthcare personnel; (v) transparent information to patients about the
quality of services provided by healthcare facilities to increase public trust in the healthcare system.
Through these activities, NAQMH / ANMCS aims to raise the standards of medical services and strengthen
the trust relationship between patients and the healthcare system, contributing to a safer and more efficient medical
system for all citizens.
In accordance with Law No. 185/2017 (RP, 2017), NAQMH / ANMCS is responsible for providing central
authorities with essential information regarding the quality of healthcare services and patient safety. Additionally,
NAQMH / ANMCS promotes the concept of quality management in healthcare and patient safety through the
publication of informational materials, the development of promotional content, and the organization of scientific
events.
To ensure effective management of healthcare service quality and patient safety, NAQMH / ANMCS has
established eight territorial offices (RG, 2018), which were fiscally registered in 2019. However, NAQMH /
ANMCS's own revenue has not been sufficient to cover the operational costs of these offices (ANMCS, 2023).

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A consistent objective of NAQMH / ANMCS has been the standardization and optimization of data
collection and transmission in electronic format, using uniform reporting forms, since the institution's
establishment.
Figure 1. Accreditation map USP / IHF (RO-2023)
Source: https://anmcs.gov.ro/web/harta-acreditarii
3.3. Activity of the Hospital Accreditation Office within NAQMH / ANMCS (2022)
In 2022, the Hospital Accreditation Office produced 47 accreditation reports. These included 27 initial
accreditation reports and 20 reclassification reports, based on the analysis of the Non-Conformity Remediation
Chart (ANMCS, 2023). As a result, in 2022, 47 healthcare facilities were classified into accreditation categories,
with their status according to the accreditation category detailed in Table 3.
Tabel 3. The situation of the 47 USP / IHF s according to the accreditation category
Source: ANMACS, 2023
The classification of the Healthcare Facility (USP / IHF) into Category V and the decision to extend the
accreditation process were determined by non-compliance with over 51% of the standards. According to
regulations, the USP must request a change to a new accreditation category within a maximum of 1 year from

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receiving the results (ANMCS, 2023). After addressing the non-conformities identified in the Non-Conformity
Chart and the indicators with a score of (-10), the USP / IHF will be re-evaluated to determine the new accreditation
category.
IV. FINDINGS WITHIN THE COMPETENCE AREA OF NAQMH / ANMCS NORTH-EAST
TERRITORIAL OFFICE (IAȘI)
The North-East Territorial Office, an integral part of NAQMH / ANMCS with legal personality, was
established to enhance the efficiency of guiding healthcare facilities in implementing the quality management and
patient safety system, as well as to monitor the maintenance of accreditation standards across all healthcare
facilities in the region (ANMCS, 2019a).
The North-East Territorial Office oversees 99 healthcare facilities with inpatient beds (USP / IHF), of which
52 are public and 47 are private. Based on the type of hospitalization, the region includes 52 USP / IHFs for
continuous and day hospitalization, 18 USP / IHFs for continuous hospitalization, and 29 USP / IHFs for day
hospitalization (ANMCS, 2019b). The distribution of these facilities across the counties of the region is illustrated
in Figure 2.
Figure 2. Distribution of USP / IHF by counties of the North-East Region
Source: https://anmcs.gov.ro/web/wp-content/uploads/2019/09/prezentare-ot-ne.pdf
In the II accreditation cycle, 24 USP / IHFs were evaluated, until the outbreak of the Covid-19 pandemic,
of which 15 were included in accreditation categories (Figure 3), for the rest (9) the procedure of accreditation.
Figure 3. Classification by accreditation categories of the 15 USP / IHFs in the North-East Region at the
level of each county (until the outbreak of the Covid-19 pandemic)
Source: https://anmcs.gov.ro/web/wp-content/uploads/2019/09/prezentare-ot-ne.pdf
Regarding the Significance of Accreditation Categories, Category I indicates that the hospital management,
the medical team, and the overseeing authority or governing body collaborate effectively to ensure the quality of
medical services and patient safety. In Categories II, III, and IV, the overall score and the proportion of indicators
with a (-10) score reflect the quality of hospital management and the work of the medical team. Additionally, the
presence of a compliance plan primarily highlights the support from the overseeing authority and, to a lesser extent,
the activities of the hospital management. Category V suggests that certain aspects of the quality of medical
services have not been sufficiently addressed by hospital management, but there is an opportunity to correct them.

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Conversely, Category VI indicates significant deficiencies in management and a lack of proper oversight from the
authorities.
For example, before the Covid-19 pandemic, there were three healthcare facilities in the North-East Region
categorized as Category II (Accredited with recommendations), two in Category III (Accredited with reservations),
one in Category IV (Accredited with low confidence), eight in Category V (Accreditation extension decision), and
one in Category VI (Not accredited), representing 6.67% of the national total (Rotaru, 2019).
Up until the onset of the pandemic, there were no national healthcare facilities categorized as Category I –
Accredited. To obtain accreditation, a hospital must correct the identified deficiencies according to a compliance
plan approved by NAQMH / ANMCS, thereby meeting the necessary criteria. These criteria must be cumulatively
met within 12 months of receiving the accreditation report and include: (i) achieving an overall compliance score
with accreditation standards of at least 51%; (ii) obtaining a score of over 51% for all accreditation standards; (iii)
reducing the proportion of indicators with a (-10) score below 50%.
Within one year of receiving the results, healthcare facilities can request that NAQMH / ANMCS analyze
and verify the non-conformities that led to a score below 51% in order to be reclassified into a different
accreditation category. This reclassification will take place after the healthcare facility addresses the indicators
specified in the Non-Conformity Remediation Plan.
V. CONCLUSION
Quality management in the health sector focuses on identifying issues within the healthcare system and
analyzing their root causes, providing well-founded recommendations to the relevant institutions to address
deficiencies. Through NAQMH / ANMCS, a quality management system is promoted based on international best
practices, which includes objective and independent evaluation of medical services, continuous monitoring, and
ongoing professional development of healthcare workers to ensure and enhance the quality and safety of services
for patients.
In the first half of 2022, NAQMH / ANMCS resumed the evaluation of healthcare facilities with beds (USP
/ IHF) as part of the second accreditation cycle and made progress in developing the necessary tools for the first
stage of accreditation of outpatient healthcare facilities.
In the future, NAQMH / ANMCS must play an active role in implementing quality assurance mechanisms
and accreditation processes for healthcare providers in both the public and private sectors. Therefore, key priorities
include:
• Improving institutional capacity for the evaluation and promotion of quality and evidence-based medicine
in health policies.
• Reviewing and enhancing the quality regulatory system, including updating the regulatory framework for
the evaluation and accreditation of all healthcare facilities with beds.
• Developing an integrated performance evaluation system, with a particular focus on quality and control
of healthcare services at all levels of care.
• Implementing the concept of clinical governance to support better organization and accountability of
clinical processes.
• Introducing and strengthening quality management mechanisms among healthcare providers, with an
emphasis on monitoring, quality improvement, continuity of care, the doctor-patient relationship, and the respect
of patient rights.
• Strengthening the capacity for monitoring and evaluating the performance of healthcare providers,
including standardizing procedures for analyzing and responding to deviations from minimum standards.
We found that important objectives of the institution analyzed include completing the second accreditation
cycle for hospitals and developing partnerships with medical universities to integrate quality management and
patient safety into the educational curriculum, thereby promoting excellence in the education and training of future
healthcare professionals.
VI. ACRONYMS OF SOME EXPRESSIONS USED IN THE WORK:
CE – Council of Europe
Co.NAS – National Hospital Accreditation Commission
EU – European Union
GO – Government Ordinance
IHF / USP – Inpatient Health Facility

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MH – Ministry of Health
NAQMH – National Agency for Quality Management in Health
NHIH – National Health Insurance House
RG – Romanian Government
RP – Romanian Parliament
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