qa policies article submitted in the ijhcqa (dr. manoochehri)

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For Peer Review Implementation of hospital quality assurance policies in Iran: Balancing the role of licensing, annual evaluation, inspections and quality management systems Journal: International Journal of Health Care Quality Assurance Manuscript ID: IJHCQA-03-2014-0034.R2 Manuscript Type: Original Article Keywords: Quality assurance, Quality improvement, Quality management, Quality assessment, licensure, Inspection International Journal of Health Care Quality Assurance

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Page 1: QA policies article submitted in the IJHCQA (Dr. Manoochehri)

For Peer Review

Implementation of hospital quality assurance policies in

Iran: Balancing the role of licensing, annual evaluation, inspections and quality management systems

Journal: International Journal of Health Care Quality Assurance

Manuscript ID: IJHCQA-03-2014-0034.R2

Manuscript Type: Original Article

Keywords: Quality assurance, Quality improvement, Quality management, Quality

assessment, licensure, Inspection

International Journal of Health Care Quality Assurance

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Article Title Page:

Title: Implementation of hospital quality assurance policies in Iran:

Balancing the role of licensing, annual evaluation, inspections and

quality management systems

Author details:

Author 1

Asgar Aghaei Hashjin*

1Department of Social Medicine, Academic Medical Center (AMC)/University of

Amsterdam, the Netherlands

2School of Health Management and Medical Information Sciences, Iran University of

Medical Sciences, Tehran, Iran

Email: [email protected]

Author 2

Bahram Delgoshaei

School of Health Management and Medical Information Sciences, Iran University of

Medical Sciences, Tehran, Iran

Email: [email protected]

Author 3

Dionne S Kringos

Department of Social Medicine, Academic Medical Center (AMC)/University of

Amsterdam, the Netherlands

Email: [email protected]

Author 4

Seyed Jamaladin Tabibi

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School of Health Management and Medical Information Sciences, Iran University of

Medical Sciences, Tehran, Iran

Email: [email protected]

Author 5

Jila Manoochehri

Tehran Heart Center Hospital, Tehran University of Medical Sciences, Tehran, Iran

Email: [email protected]

Author 6

Niek S Klazinga

Department of Social Medicine, Academic Medical Center (AMC)/University of

Amsterdam, the Netherlands

Email: [email protected]

* Corresponding author

Asgar Aghaei Hashjin, Department of Public Health, Academic Medical Centre

(AMC), University of Amsterdam (UvA), Postbox: 22660, 1100 DD, Amsterdam, the

Netherlands. Tel.: +31 205664786, Fax: +31 206972316

Email: [email protected] & [email protected]

Acknowledgments:

The authors would like to thank Dr. Hamid Ravaghi and Dr. Reza Tooyserkanmanesh

for their contributions to the data collection process, Mrs. Margot Witvliet for

commenting on the draft version of this article, and Professor Dr. Karien Stronks for

supporting this research project at the Department of Social Medicine, Academic

Medical Center (AMC) - University of Amsterdam.

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Abstract

Purpose: This paper aims to provide an overview of the applied hospital quality

assurance (QA) policies in Iran.

Design/methodology/approach: A mixed method study consisting of quantitative

data and qualitative document analysis was carried out from 1996 to 2010.

Findings: The cycle of QA policies forms a tight monitoring system to assure the

quality in hospitals using a combination of mandatory and voluntary methods in Iran.

The licensing, annual evaluation and grading, and regulatory inspections statutorily

implemented by the government as a national package to assure and improve the

quality of care in hospitals, while the implementation of quality management systems

(QMS) was voluntary for hospitals. The strong role of the government in the

legislation and support of QA policies has been an important factor for the successful

implementation of them in Iran, though it may have an effect on the independency

and validity of QA assessments. Increased hospital evaluation independency and

repositioning it, updating the standards, professionals’ involvement and effectiveness

studies could increase the impact and maturity of QA policies.

Practical implications: The study highlights the currently applied mechanism of

implementation of a cycle of QA policies in Iranian hospitals. It provides a basis for

further development and maturity of quality strategies in hospitals in Iran and

elsewhere. It also raises attention to the need to find the optimal balance between

different QA policies, which is topical for many countries.

Originality/value: For the first time, this paper describes experiences with the

implementation of a unique method combining mandatory and voluntary QA policies

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simultaneously in a less developed country which has invested considerably over time

to improve quality in its hospital sector. The experiences with a mixed

obligatory/voluntary approach and comprehensive set of policies in Iran may contain

lessons for policy makers both in developing and developed countries who are

interested to develop and implement a balanced set of QA methods more effectively

in hospitals.

Keywords: Hospital quality assurance, Evaluation, Licensure, Inspection, Quality

management systems, Iran

Article Classification: Research

Background

(Inter)national pressure on hospital quality assurance

Both the societal and policy attention to ensure quality of care in hospitals has

increased nationally and internationally over the past few decades (Berwick et al.,

2003; Cohen et al., 2008; Greenfield et al., 2008; Klazinga, 1994; Legido-Quigley et

al., 2008; McGlynn et al., 2003; Øvretveit, 2003; Shaw, 2000; Wagner et al., 2006).

Many countries around the world initiated efforts and designed national policies and

reforms to assure and improve the quality of care in their hospital sector. Some of

them legislated quality assurance (QA) policies as a national health priority. Such

policies are intended to implement standards, maintain and promote performance, and

reduce interprofessional variation in quality of care (Restuccia and Holloway,1982;

WHO, 2004-2005).

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Many European countries and recently some countries in the Middle Eastern

region (e.g. Turkey and United Arab Emirates) have focused on QA in their hospitals

(Shaw and Kalo, 2002; Gani, 1996; Emmy et al., 2001; Øvretveit, 1997; Kaya, 2000;

Zaim et al., 2010; JCI, 2014). The World Health Organization (WHO) was an

important supporter of improving the conceptualization of QA policies and the

implementation of these policies in various Member States (WHO, 2003 and 2006).

In the past decades, the accumulation of quality related problems in the hospitals

led to a reform and prioritization of QA policies in some regional countries (Kaya,

2000; Restuccia and Holloway, 1982; Preker and Harding, 2003; Zaim et al., 2010).

The current public pressure on improving the quality of care, transparency and

accountability of hospital performance, has led to increased (inter)national attention

to hospital QA policies. As a result, hospitals are increasingly expected by

governments, funders and patients to introduce policies to be accountable for their

quality and performance, increase their responsiveness of care and invest in a

continuous system of quality monitoring and improvement (Øvretveit, 2003; Wagner

et al., 2006; European Parliament, 2011).

Research has shown that hospitals vary substantially in the development and

successful implementation of QA policies both within and across countries.

Commonly applied policies include accreditation, quality management systems

(QMS), audit, patient safety mechanisms, clinical guidelines, performance indicators

and measurement and systems for obtaining patients´ views and expectations (Groene

et al., 2009; Lombarts et al., 2009; Shaw, 2009; Sunol et al., 2009). The successful

implementation and effectiveness of QA policies in hospitals depends largely on the

availability of a supportive regulatory and competitive environment, legislation,

patient focus, its alignment with financial incentives and with organizational

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leadership (Groene et al., 2010; Weiner et al., 2006; Mosadeghrad, 2014a). While

much research attention is currently paid to QA policies in developed health care

systems such as in Europe, the USA, Canada and Australia, very little is known about

the QA policy landscape, methods and experiences of implementation in less

developed health care systems such as in Iran. Iran (being the 17th largest country in

the world) is situated in the Middle East, and has more than two decades of

experience with implementing QA policies in hospitals (Mehrdad, 2009).

Quality assurance in the hospital sector in Iran

Hospital sector in Iran

Iran counts in total 850 hospitals, which are funded by the state (66%), the private

sector (9%), Iranian health organizations (8%), health insurances or charities (8%), or

by other organizations (e.g. military services) (Zarenejad and Akbari, 2009). At the

national level, the Ministry of Health and Medical Education (MOHME) is in charge

of the governance and leadership for quality, policy-making, planning, financing and

steering of the hospital sector. At provincial level, the Universities of Medical

Sciences and Health Services (UMSHS) are responsible for the provision of hospital

care (Mehrdad, 2009; WHO, 2011 and 2012).

A lack of systematic information on applied QA policies in Iranian hospitals

Currently in Iran, all hospitals are obliged to assess, assure and continuously improve

quality based on the government regulations. However, despite significant efforts,

attention and investments in QA activities, to date no systematic information is

available about the extent of implementation, mechanisms and process in which QA

policies are actually being implemented in Iranian hospitals. This study therefore aims

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to describe the extent of implementation, applied mechanisms and process of

implementation of QA policies in Iranian hospitals over the past 15 years.

Methods

A mixed qualitative and quantitative approach was used consisting of document

analysis and a questionnaire survey to study the implementation of QA policies in the

Iranian hospitals over the period 1996 to 2010. The document analysis consisted of a

review of relevant accessible official documents which were published by the

MOHME. The documents were identified and retrieved by the authors by consulting

experts in the areas of quality evaluation and inspection employed by the MOHME

and UMSHS. This was complemented by an electronic search to review the official

website of the MOHME. Authors’ personal experiences as hospital managers and

health systems researchers were also included.

The collected data were validated by taking the following steps: First, the data

were verified by ten experts involved in the administration (n=3), policy making

(n=4) or quality evaluation (n=3) of the Iranian hospitals. Second, the information

was translated from Farsi (Persian) into English by the authors. Finally, the data were

re-checked by experts qualified both in the English language and hospital

administration.

The current situation of implementation of the QA policies in the Iranian hospital

system was studied using a self-administrated validated questionnaire consisting of

closed questions. The questionnaire was translated and adopted from an existing

European project, called “Marquis” (Methods of Assessing Response to Quality

Improvement Strategies) (Groene et al., 2009; MARQuIS project consortium, 2009).

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In total, 130 questionnaires were distributed in 2010 among purposeful samples of

public, Social Security Organization (SSO), private and other groups of Iranian

hospitals. The hospitals were chosen according their willingness to participate in this

study. We aimed to have a sample of hospitals representing at least 10% of the total

number of Iranian hospitals in the final analysis by selecting 130 hospitals initially. In

each hospital the quality improvement officer or hospital manager completed the

questionnaire. The response rate was 72% (94 hospitals). Of the non-responding

hospitals 53% (19) were public, 25% (9) private, 14% (5) SSO and 8% (3) were other

groups of hospitals. Ten questionnaires were excluded from the analysis due to

incompleteness, resulting in the following distribution of respondents: 55% (n=46)

public, 25% (n=21) SSO, 14% (n=12) private and 6% (n=5) other groups of hospitals.

The study was approved by the Deputy of Research and Technology of the Iranian

University of Medical Sciences (Code: 958/1635996).

Results

The results show that a package of QA methods has been implemented in the last

decade in Iranian hospitals. It concerns a cycle of mandatory and voluntary QA

policies consisting of licensing, annual evaluation, regulatory inspections, and QMS

(ISO, EFQM, and TQM). Table 1 summarizes the extent and mechanism of

implementation of QA policies in a sample of Iranian hospitals. The table shows for

example the percentages of hospitals that implemented the ISO standards on a

voluntary basis and made it a priority.

[Insert table I about here]

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Every QA method has specific characteristics, policy support, procedures,

mechanisms of implementation and standards. This is further explained in the next

section.

Mandatory strategies

Hospital licensing

Based on the Iranian National Health Act (1955), the establishment of a new hospital

must be permitted and licensed by the MOHME. Licensing allows hospitals to legally

deliver health care services. Granting of the license is based on on-site inspection by

MOHME, which will determine if minimum health, quality and safety standards have

been met. By applying mandatory licensing, the government has control over the

establishment, performance and quality of care in the hospitals. The typical process of

an application for a hospital licensing includes two stages: 1) initial permit, and 2)

operating license.

1) Initial Permit: A permit to establish a hospital is provided to a group of 10

qualified persons in medical and/or paramedical professions organised in a so-called

“Establishment Board.”

2) Operating License: A license to open, operate and maintain a hospital is issued

if the hospital provides inpatient services 24 hours a day with an acceptable level of

quality according to national standards. Emergency Department (ED) qualification is

a prerequisite to licensing the whole hospital. The ED should first comply with the

hospital licensing requirements established by the MOHME for emergency services.

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Additional Licensing Requirements

Prior to issuing an operating license, the MOHME will assess constructional,

instrumental and personnel conditions, safety issues, (environmental) sanitation and

operating rooms, to see if requirements are met. The license to operate a hospital will

be issued if the MOHME finds the applicant and the hospital facilities in compliance

with standards, and regulations promulgated under the Hospital Licensing Act. The

hospital operating license is valid for a five-year period, but it can be suspended or

revoked at any time in case of violation of licensing regulations (including quality of

care). After five years, the license is renewable upon approval by the MOHME. In

addition, the hospital license is validated every year upon successful passing of the

annual evaluation process. From 2006 to 2009, 47 hospitals (with a total of 13,000

beds) were licensed and started to operate in Iran. In this period, the licenses of

several hospitals were suspended by the MOHME because of malfunctioning, low

quality of care, or complaints (Tabriz University of Medical Sciences, 2012).

Hospital annual evaluation

The national policy of hospital evaluation and grading was established in 1996 by the

MOHME to promote quality of care. The degree of compliance of hospitals with a set

of 15 hospital evaluation domains is assessed in a routine annual evaluation process.

The domains include hospital general facilities, medical and financial performance,

quality indicators, values, patient satisfaction, management aspects, medical and

professional staff, nursing and other staff, sanitation and cleanness, medical records

and informatics, hospital committees, hospital infrastructure, safety, medical and non-

medical equipment. Hospitals are graded subsequently based on their level of

commitment to the evaluation standards (domains) provided by the UMSHS. Under

this system, hospitals are classified on the following 6-point scale, including

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‘excellent-1’ (best performer), ‘1’, ‘2’, ‘3’, ‘below the standard’, and ‘to be shut

down’ (worst performer). The annual evaluation itself includes several other more

specific QA policies which we describe in the next section.

Hospital committees

The assessment of the functioning of hospital committees is a part of the annual

evaluation program to monitor the QA activities in Iran. Each hospital is obliged to

establish committees to assure the following quality aspects: planning for continuous

quality improvement in medical professional services; education of professional staff;

surveying of adverse events; prevention of patients’ fall and bedsore; prevention of

unsafe injections; prevention of wrong dose of drugs; and monitoring medical errors.

Clinical guidelines

In 2001, the MOHME established a set of mandatory national clinical guidelines in

the form of managed care based on Iranian national health system priorities. The

guidelines are intended to assure and improve quality of hospital care, to reduce the

use of unnecessary, ineffective or harmful interventions, and to facilitate the cost-

effective and safe treatment of patients. Currently, guidelines are in place addressing

preoperative assessment, decreasing caesarean section ratio to natural delivery,

preoperative antibiotic prophylactics, pain management, safe injections, and hospital

infections control.

Quality indicators & quality evaluation of the hospitals

In 2002, the MOHME introduced the “hospital quality evaluation plan” based on

quality indicators. The program has been mandatory since 2003 following a one-year

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voluntarily implementation in 2002. Prior to the implementation of the program, nine

quality and performance indicators were defined in 2001 to assess the quality in the

hospitals. They include:

- waiting time of the patients to be seen by a physician at the ED;

- waiting time of the patients to receive nursing services at the ED;

- patient satisfaction rate with the ED;

- the frequency of performing preoperative assessment;

- the rate of caesarean sections;

- the frequency of preoperative prophylactic antibiotic therapy;

- the provision of pain management;

- the prevalence of safe injections; and

- hospital infections rate.

The first three quality indicators provide a perspective on the hospital’s QA policy

in the ED and are referred to as “ED quality indicators.” The other six indicators

provide the opportunity to assess the quality of inpatient services (MOHME,

1996; Aghaei Hashjin et al., 2014c).

In 2006, the MOHME updated the hospital evaluation program by re-considering the

quality domains. In the new policy, five out of the 15 domains (including ED,

sanitation & cleanness, medical records & informatics, hospital committees and

quality indicators) were determined as critical domains (CDs) for the quality of care

in the hospital evaluation program. Obtaining acceptable scores for each of the five

domains is a prerequisite for the final evaluation of a hospital. Each hospital must

acquire a minimum score in each of these domains, otherwise, it will not be evaluated

until it improves the situation to an acceptable level (MOHME, 2002). The result of

the hospital quality evaluation on the CDs has not been published publically. Based

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on an internal report of the MOHME (2009) it is known that around 2% of the 570

evaluated general hospitals had problems to obtain a minimum acceptable score for at

least one quality domain in 2008.

Hospital inspections

Based on the Iranian National Health Law (1955), the MOHME is authorized to

inspect all medical facilities at all times without prior notice. Hospital directors are

obliged to provide the MOHME inspectors with all necessary information before,

during and after inspection. Hospital managers have to correct any problem in quality

of care and deficiency in construction, instruments, and administration identified by

the inspectors. Failing to overcome deficiencies will lead to shutdown of the hospital

and suspension of its license.

The following types of hospital inspections are common:

Pre-operation inspection: Prior to opening and operating a hospital, the prerequisites

set by the government must be met. No operating license will be issued without a

preliminary inspection. Granting an operating license is contingent upon signed

working contracts with medical and paramedical staff, and technical directors for all

working shifts. Compliance with all the pre-established performance and quality

standards as well as commitment to collaborate with the MOHME in emergency

situations is also necessary.

Annual on-site investigation: This is the most common hospital inspection for the

purpose of hospital license renewal which is conducted annually across the Iranian

hospitals. Inspection starts with the hospital’s ED followed by the entire hospital. All

Iranian hospitals are inspected at least once a year since 1997.

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Routine inspection following hospital annual evaluation: This is a routine post-

assessment investigation conducted to check the likelihood of non-compliance with

the annual evaluation program standards. It is an unannounced investigation to check

out the evaluation standards and quality of care on a limited scale.

Unannounced inspections: To implement a QA and risk-preventive inspection, the

MOHME has developed a series of guidelines, safety checklists and risk indicators.

Inspectors, who are normally medical specialists, routinely visit the hospitals without

prior notice at any time (mostly at midnight) and control the quality and performance

of the hospitals. These inspections normally start with the ED and can be followed by

investigation of random samples of admitted patients’ medical records. Following the

medical records investigation, inspectors may visit and interview some patients,

asking them about the quality of care they received. For every investigated record, the

inspector fills in a form reporting the details of all procedures that have been done for

the patient since admission to the hospital. Deficiencies will be reported to the

UMSHS and the inspected hospital directors as well. In case of frequently reported

deficiencies and low quality of care reports, a hospital will be in a critical situation

that could lead to its dissolution and suspension of its license.

Inspection due to complaints: Upon receipt of a complaint (on the quality of care)

directed at a hospital, the MOHME inspectors will reactively conduct an on-site

inspection focused on complaints. The results of the investigation will be sent to the

related UMSHS and the relevant organizations. Additional documentation may also

be requested. Case inspections may also be conducted in response to reports of

malfunction, a significant facility weakness, medical errors, or patient death.

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Voluntary strategies

Quality management systems

ISO and TQM: The implementation of QMS is voluntary in the public, private and

other group of hospitals, but it is mandatory in the SSO hospitals (see table 1). Of the

84 hospitals responding to the questionnaire survey, 28% of public, 25% of private,

100% of the SSO and 80% of other hospitals acknowledged implementation of at

least a series (9000, 9001 or 14001) of International Organization for Standardization

(ISO) standards in their hospitals, respectively.

The SSO, the biggest social security and insurance organization in Iran, is a

pioneer in the implementation of ISO standards attempting to ensure quality and

improve it in its affiliated hospitals. In 1999, the SSO’s policymakers officially

introduced the standardization of the SSO’s medical centers. They started to

implement total quality management (TQM) systems based on ISO standards and

mandated an ISO certificate at the affiliated medical centres. Now, after more than

one decade of efforts to implement ISO, 100% of the SSO hospitals in our survey are

certified by ISO standards. In addition, many other medical centres such as

polyclinics, clinics and day clinics are trying to be certified as well (Iranian Social

Security Organization, 2008).

European Foundation for Quality Management (EFQM): The implementation of the

EFQM excellence model was confirmed by just 26% , 17%, 5% and 20% of the

respondents in public, private, SSO and other groups of hospitals, respectively.

Approximately, 35% and 58% of the respondents in public and private hospitals

respectively reported that they do not apply any QMS at their affiliated hospitals. Of

all respondents, 54% reported that TQM is not a current priority at their hospitals.

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However, 62% of respondents in SSO’s hospitals reported using TQM as a QA

priority in their hospitals.

Discussion

Our study provides a unique insight into the extent of implementation and applied

mechanisms of the most common QA policies over the past decade in Iranian

hospitals. The study revealed that a cycle of four main mandatory and voluntary QA

methods have been implemented in Iranian hospitals; which forms a tight monitoring

system to assure the quality of care in hospitals. The licensing, annual evaluation and

grading, and regulatory inspections were statutorily implemented by the government

as a national package to assure the quality in the hospitals, while the implementation

of QMS was voluntarily for hospitals.

Forming a comprehensive quality assurance package

Continuous evaluation of quality is important to ensure that hospitals are accountable

to the public for their performance and quality of care. Currently there is a

combination of QA policies applied in the Iranian hospitals. In addition to obligatory

policies, a set of voluntary QMS policies forms the QA cycle in the Iranian hospitals.

ISO and EFQM are currently the most applied QMS conducted in the Iranian

hospitals. This has been supported by the recent recognition by the MOHME and SSO

of the suitability of EFQM and ISO models as quality policies. Farzianpour et al.

(2011) reported that many hospital managers are currently showing interest in

obtaining ISO and EFQM certificates.

The existing combination of QA policies in Iran is partly conform international

studies which have reported similar approaches including licensing, standards,

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guidelines, quality indicators, inspections, quality assessment and accreditation, as

well as QMS for QA and improvement in hospitals. Several studies of national policy

on quality development in health systems have identified a need for applying a

combination of statutory and voluntary policies to ensure quality of care and

accountability in hospitals (Øvretveit, 2003; Kaya, 2000; The standing committee of

the hospitals of the European Union, 1996; Mohammadi et al., 2007; Shaw, 2001 and

2003).

A continuous cycle of quality assurance activities

The cycle of QA policies starts with the institutional time-limited licensing before a

new hospital starts to operate. It continues with the performance of regulatory

frequent inspections, systematic performance measurement and annual evaluation,

extensive grading, and license renewal following a satisfactory on-site inspection.

These methods are completed with voluntary QMS to ensure and improve quality of

care in hospitals. Some other studies have also identified a continuous cycle of

performance measurement, valid standards, clinical guidelines, repeated measurement

and continuous improvement policies in hospitals in the past two decades. There are

some similarities in QA policies between the Iranian hospitals and those in other

countries. But, the extent and methods of implementation, legal requirements for QA,

standard setting process, funding, and policy incentives are substantially different

(Shaw, 2002).

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Role of government, professionals, and patients in implementing quality

assurance policies

Government

The QA procedure in Iran is mainly funded by the government to guarantee the

quality of care in hospitals. The government legislates the main QA policies and

provides resources for the conduction of the policies by involving the UMSHSs in the

implementation process. The UMSHSs have a strong role across the country in the

process by providing a supportive environment, standards, guidelines and technical

advice. Some studies revealed that legislation of QA policies and statutory supports

are major incentives for the implementation and effectiveness of the policies (Shaw,

2002; Emmy et al., 2001; Eldar and Ronen, 1995). The statutory steerage of activities

and a leadership role by the government is an important incentive and guarantees the

implementation of QA policies at national level (Mosadeghrad, 2014b). However,

such involvement by the governmental may not provide a credible independency and

validity of assessment (Shaw, 2004; Spencer and Walshe, 2009).

Professionals

The success of QA policies depends on the interest and involvement of the

professionals (including administrators, physicians, and nurses) working in the

hospitals (Tengilimoglu, 2013; Mosadeghrad, 2014a). In spite of the increasing

national interest in different QA policies, we did not find much contribution,

involvement or interest among the hospital professionals for the development and

implementation of the policies in Iran (Aghaei Hashjin et al., 2014c). As physicians,

nurses, quality improvement officers, and administrators play a minor (or no) role in

developing the QA policies. This may directly affect the effectiveness of the

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implementation of QA policies in hospitals. (StorageMart, 2013; Mosadeghrad,

2014a,b).

Patients

Several studies have identified that focusing on patients and patient surveys can

provide insight into the effectiveness and successful implementation of QA policies as

they can reflect the overall quality of hospital care provided (Mosadeghrad, 2014b;

Taner and Antony, 2006). The patient satisfaction measurement, patient safety,

consideration of patient values and expectations, and attention for patients’

complaints are the main potential outcomes of current QA policies in hospitals in Iran.

However, the real influence of the policies on patients needs to be further investigated

(Aghaei Hashjin et al., 2014b).

Effectiveness of applied policies

The compulsory system of hospital evaluation and performance measurement,

committees, quality indicators and national clinical guidelines has been reported as

important QA polices in the health care system (Shaw, 2002; Klazinga, 1996).

However, the effectiveness of the performance of these instruments is currently

unknown. It seems there is a need to investigate the impact of annual evaluations and

functioning of the hospital committees, methods of measuring indicators, reliability of

provided performance data, and the accuracy of clinical guidelines on the quality of

hospital care in Iran (Aghaei Hashjin et al., 2014a).

The effectiveness of the statutory inspections made by different authorized

organizations also calls for further investigation. Most of the inspections are

preventive rather than complaint-based investigations. Although inspections have

improved organizational performance of hospitals, there is some evidence that

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hospitals increase their compliance with the standards prior to the inspections. Such

(pressured) ad hoc quality improvements may not be the optimal way to achieve a

culture of continuous quality improvement in hospitals. Other studies reported the

same consequences of announced inspections (Shaw, 2004).

Although a variety of QA policies are being used in the Iranian hospital system,

no research has been conducted on assessing the effectiveness of one or more quality

policies that can be used to assure quality in the Iranian hospitals. Optimising the right

balance between the implemented policies seems a logical next step in the evolution

process of QA in Iran. In addition, it seems the currently ongoing repositioning and

maturing of the evaluation and performance measurement program towards an

accreditation program in Iranian hospitals is a positive move towards further

promoting the fulfillment of QA reguirements (MOHME, 2011). It is recommended

to also increase the focus on creating a supportive organizational culture at hospital

level to increase the uptake of quality improvement activities. The authors therefore

advocate further research focusing on the effectiveness of current QA policies and

related factors that may facilitate or hamper the implementation of hospital QA in

Iran.

Strengths and limitations

This is the first study providing insight into the currently applied QA policies in the

hospital sector in Iran. The comprehensive scope of the study, use of a national

sample of hospitals, and mixed method of a validated questionnaire survey and

document review, are strong features of the study design. However, limited access to

readily available information on the current QA policies, determining the validity of

original descriptive data and translation from the original language (Farsi) into

English were limitations of our study.

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Conclusions

The implemented cycle of QA policies forms a tight and comprehensive monitoring

system to assure the quality of care in hospitals using a combination of mandatory and

voluntary methods in Iran. The statutory legal requirement for hospitals to

continuously improve the quality of hospital care is an important incentive for the

implementation these policies. The government’s strong external role in steering of

QA policies has been a key factor for high implementation level of the policies by

hospitals in Iran. The ongoing repositioning of the current hospital evaluation

program into an accreditation system and activities to further mature the hospital

quality assurance system are positive movements that are recommended to be

continued. It is currently unknown what the optimal balance of the currently applied

QA policies would be. Further insight into the effectiveness of current QA policies

and related factors that may facilitate or hamper the implementation of hospital QA in

Iran will increase our knowledge on how to effectively improve the quality of care in

hospitals.

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References

Aghaei Hashjin A, Kringos DS, Manoochehri J, Aryankhesal A and Klazinga NS. (2014a)

Development and impact of the Iranian hospital performance measurement program.

BMC Health Services Research, forthcoming.

Aghaei Hashjin A, Kringos DS, Manoochehri J, Ravaghi H and Klazinga NS. (2014b)

Implementation of patient safety and patient-centeredness strategies in Iranian

hospitals. PLOS ONE, forthcoming.

Aghaei Hashjin A, Ravaghi H, Kringos DS, Ogbu UC, Fischer C, Azami SR and Klazinga

NS. (2014c), Using Quality Measures for Quality Improvement: The Perspective of

Hospital Staff. PLOS ONE, January 23, 2014, DOI: 10.1371/journal.pone.0086014.

Berwick, D.M., James, B. and Coye, M.J. (2003), Connections between quality measurement

and improvement. Medical Care, 41: I30-I38.

Cohen, A.B., Restuccia, J.D., Shwartz, M., Drake, J.E., Kang, R., Kralovec, P., Holmes, S.,

Margolin, F. and Bohr, D. (2008), A survey of hospital quality improvement

activities. Medical Care Research and Review, 65: 571-595.

Eldar, R. and Ronen, R. (1995), Implementation and evaluation of a quality assurance

programme. International Journal of Health Care Quality Assurance, Vol. 8 No. 1,

pp. 28-32.

European Parliament. (2011), Directive 2011/24/EU of the European Parliament and of the

Council on the application of patients' rights in cross-border healthcare. 2011/24/EU.

Farzianpour, f., Aghababa, S., Delgoshaei, B., and Haghgoo, M. (2011), Performance Evaluation a

Teaching Hospital Affiliated to Tehran University of Medical Sciences Based on

Baldrige Excellence Model. American Journal of Economics and Business

Administration 3 (2): 277-281.

Greenfield, D. and Braithwaite, J. (2008), Health sector accreditation research: a systematic

review. International Journal for Quality in Health Care, 20: 172-183.

Gani, A. (1996), Improving quality in public sector hospitals in Indonesia. The International

Journal of Health Planning and Management, Volume 11, Issue 3, pages 275–296.

Groene, O., Klazinga, N., Wagner, C., Arah, O.A., Thompson, A., Bruneau, C. and Sunol, R.

(2010), Investigating organizational quality improvement systems, patient

empowerment, organizational culture, professional involvement and the quality of

care in European hospitals: the 'Deepening our Understanding of Quality

Improvement in Europe (DUQuE)' project. BMC Health Services Research, 10: 281.

Groene, O., Klazinga, N., Walshe, K., Cucic, C., Shaw, C.D. and Sunol, R. (2009), Learning

from MARQuIS: future direction of quality and safety in hospital care in the

European Union. Quality and Safety in Health Care, 18 Suppl 1: i69-i74.

Page 22 of 51International Journal of Health Care Quality Assurance

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960

Page 24: QA policies article submitted in the IJHCQA (Dr. Manoochehri)

For Peer Review

- 23 -

Groene, O., Lombarts, M.J., Klazinga, N., Alonso, J., Thompson, A. and Sunol, R. (2009), Is

patient-centredness in European hospitals related to existing quality improvement

strategies? Analysis of a cross-sectional survey (MARQuIS study). Quality and Safety

in Health Care, 18 Suppl 1: i44-i50.

HOPE (The standing committee of the hospitals of the European Union). 1996. The quality of

hospital care in the European Union, Leuven.

JCI (Joint Commission International). (2014), Number of hospitals accreditted by JCI.

http://www.jointcommissioninternational.org/about-jci/jci-accredited-organizations/

accessed March 2014.

Kaya, S. (2000), Developing a quality management program for the ministry of health

hospitals in Turkey, Takemi program in international health, Harvard School of

Public Health, USA.

Klazinga, N. (1994), Concerted action programme on quality assurance in hospitals 1990-

1993 (COMAC/HSR/QA). Global results of the evaluation. International Journal of

Health Care Quality Assurance, 6: 219-230.

Klazinga, N. (1996), Implementing clinical guidelines in hospitals and acute care settings. A

European perspective: context, content and consequences of practice guidelines in

European hospitals.

Legido-Quigley, H., McKee, M., Walshe, K., Sunol, R., Nolte, E. and Klazinga, N. (2008),

How can quality of health care be safeguarded across the European Union? British

Medical Journal, 336: 920-923.

Lombarts, M.J., Rupp, I., Vallejo, P., Klazinga, N. and Sunol, R. (2009), Differentiating

between hospitals according to the "maturity" of quality improvement systems: a new

classification scheme in a sample of European hospitals. Quality and Safety in Health

Care, 18 Suppl 1: i38-i43.

MARQuIS project consortium. (2009), The MARQuIS Questionnaire.

http://www.marquisquestionnaire.nl/marquis/index.asp, accessed July 2009.

McGlynn, E.A., Asch, S.M., Adams, J., Keesey, J., Hicks, J., DeCristofaro, A. and Kerr, E.A.

2003. The quality of health care delivered to adults in the United States. The New

England Journal of Medicine, 348: 2635-2645.

Mehrdad, R. (2009), Health System in Iran. Journal of the Japan Medical Association, 52:

69-73.

Mohammadi, S.M., Mohammadi, S.F., Hedges, J.R., Zohrabi, M. and Ameli O. (2007),

Introduction of a quality improvement program in a children's hospital in Tehran:

design, implementation, evaluation and lessons learned. International Journal of

Health Care Quality Assurance, 19: 237-243.

Page 23 of 51 International Journal of Health Care Quality Assurance

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960

Page 25: QA policies article submitted in the IJHCQA (Dr. Manoochehri)

For Peer Review

- 24 -

MOHME. (1996), Department of accrediation and standards of general hospitals. Teheran,

Iran.

MOHME. (2002), Practical instruction to quality evaluation in hospitals (in Farsi), The

Ministry of Health and Medical Education, Tehran, Iran.

MOHME. (2009), The trend of changing general hospitals’ grades from 2005 to 2008.

MOHME. (2011), Hospital Accreditation Standards in Iran.

Mosadeghrad, A M. (2014a) "Essentials of Total Quality Management: A Meta-Analysis",

International Journal of Health Care Quality Assurance, Vol. 27 Iss: 6.

Mosadeghrad, A M. (2014b) "Why TQM does not work in Iranian healthcare organisations",

International Journal of Health Care Quality Assurance, Vol. 27 No: 4.

Øvretveit, J. (2003), What are the best strategies for ensuring quality in hospitals?

Copenhagen, WHO Regional Office for Europe Health Evidence Network (HEN).

Øvretveit, J. (1997), Would it work for us? Learning from quality improvement in Europe

and beyond. The Joint Commission Journal on Quality Improvement; 23 (1): 7-22.

Preker, A.S. and Harding, A. (2003), Innovations in health service delivery: The

corporatization of public hospitals. The World Bank, Washington DC.

Restuccia, J.D. and Holloway, D.C. (1982), Methods of control for hospital quality assurance

systems. Health Services Research, 17: 241-251.

Shaw, C.D. and Kalo, I. (2002), A background for national quality policies in health systems,

WHO Regional Office for Europe, Copenhagen, Denmark.

Shaw, C.D., Kutryba, B., Crisp, H., Vallejo, P. and Sunol, R. (2009), Do European hospitals

have quality and safety governance systems and structures in place? Quality and

Safety in Health Care, 18 Suppl 1: i51-i56.

Shaw, C.D. (2001), External assessment of health care. British Medical Journal, 322: 851-

854.

Shaw, C.D. (2000), External quality mechanisms for health care: summary of the ExPeRT

project on visitatie, accreditation, EFQM and ISO assessment in European Union

countries. External Peer Review Techniques. European Foundation for Quality

Management. International Organization for Standardization. International Journal of

Health Care Quality Assurance, 12: 169-175.

Shaw, C.D. (2003), How can hospital performance be measured and monitored? WHO

Regional Office for Europe (HEN Network, Copenhagen, Denmark.

Shaw, C.D. (2004), The external assessment of health services. World Hospitals and Health

Services, 40: 24-7, 50, 51.

Page 24 of 51International Journal of Health Care Quality Assurance

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960

Page 26: QA policies article submitted in the IJHCQA (Dr. Manoochehri)

For Peer Review

- 25 -

Spencer, E. and Walshe, K. (2009), National quality improvement policies and strategies in

European healthcare systems. Quality and Safety in Health Care, 18 Suppl 1: i22-i27.

SSO (Iranian Social Security Organization). (2008), The Group of Indicators Survey.

Teheran, Iran.

StorageMart. (2013), http://www.totalqualityassuranceservices.com/establishing-hospital-

quality-assurance-programs/, accessed 15-05-2013.

Sunol, R., Garel, P. and Jacquerye, A. (2009), Cross-border care and healthcare quality

improvement in Europe: the MARQuIS research project. Quality and Safety in Health

Care, 18 Suppl 1: i3-i7.

Sunol, R., Vallejo, P., Groene, O., Escaramis, G., Thompson, A., Kutryba, B. and Garel, P.

(2009), Implementation of patient safety strategies in European hospitals. Quality and

Safety in Health Care, 18 Suppl 1: i57-i61.

Tabriz University of Medical Sciences. (2012), http://treatment.tbzmed.ac.ir/, accessed

November 2012.

Taner T and Antony J. (2006), Comparing public and private hospital care service quality in

Turkey. Int J Health Care Qual Assur Inc Leadersh Health Serv.19(2-3):i-x.

Tengilimoglu, D., Celik, Y., Akbolat, M., Isik, O. and Kurtuldu, A. (2013), Asssessment of

Health Administration Education: A Field Practice in Turkey. J. Asian Dev. Stud, Vol. 2, Issue 1.

Wagner, C., Gulacsi, L., Takacs, E. and Outinen, M. (2006), The implementation of quality

management systems in hospitals: a comparison between three countries. BMC Health

Services Research, 6: 50.

Weiner, B.J., Alexander, J.A., Shortell, S.M., Baker, L.C., Becker, M. and Geppert, J.J.

(2006), Quality improvement implementation and hospital performance on quality

indicators. Health Services Research, 41: 307-334.

WHO. (2011), Country Cooperation Strategy for WHO and the Islamic Republic of Iran

20120-2014. EM/ARD/038/E. Regional Office for the Eastern Mediterranean. Cairo.

WHO. (2004-2005), Eastern Mediterranean Regional Office (EMRO), Division of Health

System and Services Development, Health Policy and Planning Unit,

http://gis.emro.who.int/HealthSystemObservatory/PDF/InstrumentsAndTools/

Glossary.pdf, accessed May 2013.

WHO. (2003), Evidence and Information for Policy, Department of Health Service Provision,

Geneva.

WHO. (2006), Health Systems Profile- Lebanon Regional Health Systems Observatory-

Regional Office for Eastern Mediterranean (EMRO),

http://gis.emro.who.int/HealthSystemObservatory/PDF/Lebanon/FullProfile, accessed

May 2013]

Page 25 of 51 International Journal of Health Care Quality Assurance

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960

Page 27: QA policies article submitted in the IJHCQA (Dr. Manoochehri)

For Peer Review

- 26 -

WHO. (2006), Health Systems Profile- Saudi Arabia Regional Health Systems Observatory-

Regional Office for Eastern Mediterranean (EMRO),

http://gis.emro.who.int/HealthSystemObservatory/PDF/SaudiArabia/Full Profile,

accessed May 2013.

WHO. (2012), Health Systems Profile: Islamic Republic of Iran. Regional Health Systems

Observatory WHO (EMRO), Cairo.

Zaim, H, Bayyurt, N, Zaim, S. (2010), Service Quality And Determinants Of Customer

Satisfaction In Hospitals: Turkish Experience. International Business & Economics

Research Journal – May 2010 Volume 9, Number 5.

Zarenejad, A. and Akbari, M. (2009), A report on 30 years performance of the Iranian

Ministry of Health and Medical Education (MOHME). Teheran, Iran.

Table I - The coverage and mechanism of implementation of quality assurance

policies in Iranian hospitals (n=84)

Note:

QA: Quality assurance

EFQM: European Foundation for Quality Management

TQM: total quality management

ISO: International Organization for Standardization

Mechanism and coverage of implementation by type of hospital

QA Policies

Mandatory

% (n)

Voluntary

% (n)

Govern-

ment

hospitals

Private

hospitals

SSO

hospitals

Other

hospitals

Govern-

ment

hospitals

Private

hospitals

SSO

hospitals

Other

hospitals

Licensure, annual evaluation and

inspections

100 (46) 100 (12) 100 (21) 100 (5) 0 0 0 0

Quality

management

systems (QMS)

ISO - - 100 (21) - 28 (13) 25 (3) 0 80 (4)

EFQM - - - - 26 (12) 17 (2) 5 (1) 20 (1)

Other - - - - 11 (5) 0 0 0

None - - - - 35 (16) 58 (7) 95 (20) 0

TQM

(as a QA priority in

hospital)

1st priority - - - - 15 (7) 8 (1) 19 (4) 0

2nd priority - - - - 4 (2) 0 24 (5) 0

3rd priority - - - - 28 (13) 25 (3) 19 (4) 20 (1)

No priority - - - - 53 (24) 67 (8) 38 (8) 80 (4)

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Implementation of hospital quality assurance policies in Iran:

Balancing the role of licensing, annual evaluation, inspections and

quality management systems

Abstract

Purpose: This paper aims to provide an overview of the applied hospital quality

assurance (QA) policies in Iran.

Design/methodology/approach: A mixed method study consisting of quantitative

data and qualitative document analysis was carried out from 1996 to 2010.

Findings: The cycle of QA policies forms a tight monitoring system to assure the

quality in hospitals using a combination of mandatory and voluntary methods in Iran.

The licensing, annual evaluation and grading, and regulatory inspections statutorily

implemented by the government as a national package to assure and improve the

quality of care in hospitals, while the implementation of quality management systems

(QMS) was voluntary for hospitals. The strong role of the government in the

legislation and support of QA policies has been an important factor for the successful

implementation of them in Iran, though it may have an effect on the independency

and validity of QA assessments. Increased hospital evaluation independency and

repositioning it, updating the standards, professionals’ involvement and effectiveness

studies could increase the impact and maturity of QA policies.

Practical implications: The study highlights the currently applied mechanism of

implementation of a cycle of QA policies in Iranian hospitals. It provides a basis for

further development and maturity of quality strategies in hospitals in Iran and

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elsewhere. It also raises attention to the need to find the optimal balance between

different QA policies, which is topical for many countries.

Originality/value: For the first time, this paper describes experiences with the

implementation of a unique method combining mandatory and voluntary QA policies

simultaneously in a less developed country which has invested considerably over time

to improve quality in its hospital sector. The experiences with a mixed

obligatory/voluntary approach and comprehensive set of policies in Iran may contain

lessons for policy makers both in developing and developed countries who are

interested to develop and implement a balanced set of QA methods more effectively

in hospitals.

Keywords: Hospital quality assurance, Evaluation, Licensure, Inspection, Quality

management systems, Iran

Article Classification: Research

Background

(Inter)national pressure on hospital quality assurance

Both the societal and policy attention to ensure quality of care in hospitals has

increased nationally and internationally over the past few decades (Berwick et al.,

2003; Cohen et al., 2008; Greenfield et al., 2008; Klazinga, 1994; Legido-Quigley et

al., 2008; McGlynn et al., 2003; Øvretveit, 2003; Shaw, 2000; Wagner et al., 2006).

Many countries around the world initiated efforts and designed national policies and

reforms to assure and improve the quality of care in their hospital sector. Some of

them legislated quality assurance (QA) policies as a national health priority. Such

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policies are intended to implement standards, maintain and promote performance, and

reduce interprofessional variation in quality of care (Restuccia and Holloway,1982;

WHO, 2004-2005).

Many European countries and recently some countries in the Middle Eastern

region (e.g. Turkey and United Arab Emirates) have focused on QA in their hospitals

(Shaw and Kalo, 2002; Gani, 1996; Emmy et al., 2001; Øvretveit, 1997; Kaya, 2000;

Zaim et al., 2010; JCI, 2014). The World Health Organization (WHO) was an

important supporter of improving the conceptualization of QA policies and the

implementation of these policies in various Member States (WHO, 2003 and 2006).

In the past decades, the accumulation of quality related problems in the hospitals

led to a reform and prioritization of QA policies in some regional countries (Kaya,

2000; Restuccia and Holloway, 1982; Preker and Harding, 2003; Zaim et al., 2010).

The current public pressure on improving the quality of care, transparency and

accountability of hospital performance, has led to increased (inter)national attention

to hospital QA policies. As a result, hospitals are increasingly expected by

governments, funders and patients to introduce policies to be accountable for their

quality and performance, increase their responsiveness of care and invest in a

continuous system of quality monitoring and improvement (Øvretveit, 2003; Wagner

et al., 2006; European Parliament, 2011).

Research has shown that hospitals vary substantially in the development and

successful implementation of QA policies both within and across countries.

Commonly applied policies include accreditation, quality management systems

(QMS), audit, patient safety mechanisms, clinical guidelines, performance indicators

and measurement and systems for obtaining patients´ views and expectations (Groene

et al., 2009; Lombarts et al., 2009; Shaw, 2009; Sunol et al., 2009). The successful

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implementation and effectiveness of QA policies in hospitals depends largely on the

availability of a supportive regulatory and competitive environment, legislation,

patient focus, its alignment with financial incentives and with organizational

leadership (Groene et al., 2010; Weiner et al., 2006; Mosadeghrad, 2014a). While

much research attention is currently paid to QA policies in developed health care

systems such as in Europe, the USA, Canada and Australia, very little is known about

the QA policy landscape, methods and experiences of implementation in less

developed health care systems such as in Iran. Iran (being the 17th largest country in

the world) is situated in the Middle East, and has more than two decades of

experience with implementing QA policies in hospitals (Mehrdad, 2009).

Quality assurance in the hospital sector in Iran

Hospital sector in Iran

Iran counts in total 850 hospitals, which are funded by the state (66%), the private

sector (9%), Iranian health organizations (8%), health insurances or charities (8%), or

by other organizations (e.g. military services) (Zarenejad and Akbari, 2009). At the

national level, the Ministry of Health and Medical Education (MOHME) is in charge

of the governance and leadership for quality, policy-making, planning, financing and

steering of the hospital sector. At provincial level, the Universities of Medical

Sciences and Health Services (UMSHS) are responsible for the provision of hospital

care (Mehrdad, 2009; WHO, 2011 and 2012).

A lack of systematic information on applied QA policies in Iranian hospitals

Currently in Iran, all hospitals are obliged to assess, assure and continuously improve

quality based on the government regulations. However, despite significant efforts,

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attention and investments in QA activities, to date no systematic information is

available about the extent of implementation, mechanisms and process in which QA

policies are actually being implemented in Iranian hospitals. This study therefore aims

to describe the extent of implementation, applied mechanisms and process of

implementation of QA policies in Iranian hospitals over the past 15 years.

Methods

A mixed qualitative and quantitative approach was used consisting of document

analysis and a questionnaire survey to study the implementation of QA policies in the

Iranian hospitals over the period 1996 to 2010. The document analysis consisted of a

review of relevant accessible official documents which were published by the

MOHME. The documents were indentified and retrieved by the authors by consulting

experts in the areas of quality evaluation and inspection employed by the MOHME

and UMSHS. This was complemented by an electronic search to review the official

website of the MOHME. Authors’ personal experiences as hospital managers and

health systems researchers were also included.

The collected data were validated by taking the following steps: First, the data

were verified by ten experts involved in the administration (n=3), policy making

(n=4) or quality evaluation (n=3) of the Iranian hospitals. Second, the information

was translated from Farsi (Persian) into English by the authors. Finally, the data were

re-checked by experts qualified both in the English language and hospital

administration.

The current situation of implementation of the QA policies in the Iranian hospital

system was studied using a self-administrated validated questionnaire consisting of

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closed questions. The questionnaire was translated and adopted from an existing

European project, called “Marquis” (Methods of Assessing Response to Quality

Improvement Strategies) (Groene et al., 2009; MARQuIS project consortium, 2009).

In total, 130 questionnaires were distributed in 2010 among purposeful samples of

public, Social Security Organization (SSO), private and other groups of Iranian

hospitals. The hospitals were chosen according their willingness to participate in this

study. We aimed to have a sample of hospitals representing at least 10% of the total

number of Iranian hospitals in the final analysis by selecting 130 hospitals initially. In

each hospital the quality improvement officer or hospital manager completed the

questionnaire. The response rate was 72% (94 hospitals). Of the non-responding

hospitals 53% (19) were public, 25% (9) private, 14% (5) SSO and 8% (3) were other

groups of hospitals. Ten questionnaires were excluded from the analysis due to

incompleteness, resulting in the following distribution of respondents: 55% (n=46)

public, 25% (n=21) SSO, 14% (n=12) private and 6% (n=5) other groups of hospitals.

The study was approved by the Deputy of Research and Technology of the Iranian

University of Medical Sciences (Code: 958/1635996).

Results

The results show that a package of QA methods has been implemented in the last

decade in Iranian hospitals. It concerns a cycle of mandatory and voluntary QA

policies consisting of licensing, annual evaluation, regulatory inspections, and QMS

(ISO, EFQM, and TQM). Table 1 summarizes the extent and mechanism of

implementation of QA policies in a sample of Iranian hospitals. The table shows for

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example the percentages of hospitals that implemented the ISO standards on a

voluntary basis and made it a priority.

[Insert table I about here]

Every QA method has specific characteristics, policy support, procedures,

mechanisms of implementation and standards. This is further explained in the next

section.

Mandatory strategies

Hospital licensing

Based on the Iranian National Health Act (1955), the establishment of a new hospital

must be permitted and licensed by the MOHME. Licensing allows hospitals to legally

deliver health care services. Granting of the license is based on on-site inspection by

MOHME, which will determine if minimum health, quality and safety standards have

been met. By applying mandatory licensing, the government has control over the

establishment, performance and quality of care in the hospitals. The typical process of

an application for a hospital licensing includes two stages: 1) initial permit, and 2)

operating license.

1) Initial Permit: A permit to establish a hospital is provided to a group of 10

qualified persons in medical and/or paramedical professions organised in a so-called

“Establishment Board.”

2) Operating License: A license to open, operate and maintain a hospital is issued

if the hospital provides inpatient services 24 hours a day with an acceptable level of

quality according to national standards. Emergency Department (ED) qualification is

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a prerequisite to licensing the whole hospital. The ED should first comply with the

hospital licensing requirements established by the MOHME for emergency services.

Additional Licensing Requirements

Prior to issuing an operating license, the MOHME will assess constructional,

instrumental and personnel conditions, safety issues, (environmental) sanitation and

operating rooms, to see if requirements are met. The license to operate a hospital will

be issued if the MOHME finds the applicant and the hospital facilities in compliance

with standards, and regulations promulgated under the Hospital Licensing Act. The

hospital operating license is valid for a five-year period, but it can be suspended or

revoked at any time in case of violation of licensing regulations (including quality of

care). After five years, the license is renewable upon approval by the MOHME. In

addition, the hospital license is validated every year upon successful passing of the

annual evaluation process. From 2006 to 2009, 47 hospitals (with a total of 13,000

beds) were licensed and started to operate in Iran. In this period, the licenses of

several hospitals were suspended by the MOHME because of malfunctioning, low

quality of care, or complaints (Tabriz University of Medical Sciences, 2012).

Hospital annual evaluation

The national policy of hospital evaluation and grading was established in 1996 by the

MOHME to promote quality of care. The degree of compliance of hospitals with a set

of 15 hospital evaluation domains is assessed in a routine annual evaluation process.

The domains include hospital general facilities, medical and financial performance,

quality indicators, values, patient satisfaction, management aspects, medical and

professional staff, nursing and other staff, sanitation and cleanness, medical records

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and informatics, hospital committees, hospital infrastructure, safety, medical and non-

medical equipment. Hospitals are graded subsequently based on their level of

commitment to the evaluation standards (domains) provided by the UMSHS. Under

this system, hospitals are classified on the following 6-point scale, including

‘excellent-1’ (best performer), ‘1’, ‘2’, ‘3’, ‘below the standard’, and ‘to be shut

down’ (worst performer). The annual evaluation itself includes several other more

specific QA policies which we describe in the next section.

Hospital committees

The assessment of the functioning of hospital committees is a part of the annual

evaluation program to monitor the QA activities in Iran. Each hospital is obliged to

establish committees to assure the following quality aspects: planning for continuous

quality improvement in medical professional services; education of professional staff;

surveying of adverse events; prevention of patients’ fall and bedsore; prevention of

unsafe injections; prevention of wrong dose of drugs; and monitoring medical errors.

Clinical guidelines

In 2001, the MOHME established a set of mandatory national clinical guidelines in

the form of managed care based on Iranian national health system priorities. The

guidelines are intended to assure and improve quality of hospital care, to reduce the

use of unnecessary, ineffective or harmful interventions, and to facilitate the cost-

effective and safe treatment of patients. Currently, guidelines are in place addressing

preoperative assessment, decreasing caesarean section ratio to natural delivery,

preoperative antibiotic prophylactics, pain management, safe injections, and hospital

infections control.

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Quality indicators & quality evaluation of the hospitals

In 2002, the MOHME introduced the “hospital quality evaluation plan” based on

quality indicators. The program has been mandatory since 2003 following a one-year

voluntarily implementation in 2002. Prior to the implementation of the program, nine

quality and performance indicators were defined in 2001 to assess the quality in the

hospitals. They include:

- waiting time of the patients to be seen by a physician at the ED;

- waiting time of the patients to receive nursing services at the ED;

- patient satisfaction rate with the ED;

- the frequency of performing preoperative assessment;

- the rate of caesarean sections;

- the frequency of preoperative prophylactic antibiotic therapy;

- the provision of pain management;

- the prevalence of safe injections; and

- hospital infections rate.

The first three quality indicators provide a perspective on the hospital’s QA policy in

the ED and are referred to as “ED quality indicators.” The other six indicators provide

the opportunity to assess the quality of inpatient services (MOHME, 1996; Aghaei

Hashjin et al., 2014c).

In 2006, the MOHME updated the hospital evaluation program by re-considering the

quality domains. In the new policy, five out of the 15 domains (including ED,

sanitation & cleanness, medical records & informatics, hospital committees and

quality indicators) were determined as critical domains (CDs) for the quality of care

in the hospital evaluation program. Obtaining acceptable scores for each of the five

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domains is a prerequisite for the final evaluation of a hospital. Each hospital must

acquire a minimum score in each of these domains, otherwise, it will not be evaluated

until it improves the situation to an acceptable level (MOHME, 2002). The result of

the hospital quality evaluation on the CDs has not been published publically. Based

on an internal report of the MOHME (2009) it is known that around 2% of the 570

evaluated general hospitals had problems to obtain a minimum acceptable score for at

least one quality domain in 2008.

Hospital inspections

Based on the Iranian National Health Law (1955), the MOHME is authorized to

inspect all medical facilities at all times without prior notice. Hospital directors are

obliged to provide the MOHME inspectors with all necessary information before,

during and after inspection. Hospital managers have to correct any problem in quality

of care and deficiency in construction, instruments, and administration identified by

the inspectors. Failing to overcome deficiencies will lead to shutdown of the hospital

and suspension of its license.

The following types of hospital inspections are common:

Pre-operation inspection: Prior to opening and operating a hospital, the prerequisites

set by the government must be met. No operating license will be issued without a

preliminary inspection. Granting an operating license is contingent upon signed

working contracts with medical and paramedical staff, and technical directors for all

working shifts. Compliance with all the pre-established performance and quality

standards as well as commitment to collaborate with the MOHME in emergency

situations is also necessary.

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Annual on-site investigation: This is the most common hospital inspection for the

purpose of hospital license renewal which is conducted annually across the Iranian

hospitals. Inspection starts with the hospital’s ED followed by the entire hospital. All

Iranian hospitals are inspected at least once a year since 1997.

Routine inspection following hospital annual evaluation: This is a routine post-

assessment investigation conducted to check the likelihood of non-compliance with

the annual evaluation program standards. It is an unannounced investigation to check

out the evaluation standards and quality of care on a limited scale.

Unannounced inspections: To implement a QA and risk-preventive inspection, the

MOHME has developed a series of guidelines, safety checklists and risk indicators.

Inspectors, who are normally medical specialists, routinely visit the hospitals without

prior notice at any time (mostly at midnight) and control the quality and performance

of the hospitals. These inspections normally start with the ED and can be followed by

investigation of random samples of admitted patients’ medical records. Following the

medical records investigation, inspectors may visit and interview some patients,

asking them about the quality of care they received. For every investigated record, the

inspector fills in a form reporting the details of all procedures that have been done for

the patient since admission to the hospital. Deficiencies will be reported to the

UMSHS and the inspected hospital directors as well. In case of frequently reported

deficiencies and low quality of care reports, a hospital will be in a critical situation

that could lead to its dissolution and suspension of its license.

Inspection due to complaints: Upon receipt of a complaint (on the quality of care)

directed at a hospital, the MOHME inspectors will reactively conduct an on-site

inspection focused on complaints. The results of the investigation will be sent to the

related UMSHS and the relevant organizations. Additional documentation may also

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be requested. Case inspections may also be conducted in response to reports of

malfunction, a significant facility weakness, medical errors, or patient death.

Voluntary strategies

Quality management systems

ISO and TQM: The implementation of QMS is voluntary in the public, private and

other group of hospitals, but it is mandatory in the SSO hospitals (see table 1). Of the

84 hospitals responding to the questionnaire survey, 28% of public, 25% of private,

100% of the SSO and 80% of other hospitals acknowledged implementation of at

least a series (9000, 9001 or 14001) of International Organization for Standardization

(ISO) standards in their hospitals, respectively.

The SSO, the biggest social security and insurance organization in Iran, is a

pioneer in the implementation of ISO standards attempting to ensure quality and

improve it in its affiliated hospitals. In 1999, the SSO’s policymakers officially

introduced the standardization of the SSO’s medical centers. They started to

implement total quality management (TQM) systems based on ISO standards and

mandated an ISO certificate at the affiliated medical centres. Now, after more than

one decade of efforts to implement ISO, 100% of the SSO hospitals in our survey are

certified by ISO standards. In addition, many other medical centres such as

polyclinics, clinics and day clinics are trying to be certified as well (Iranian Social

Security Organization, 2008).

European Foundation for Quality Management (EFQM): The implementation of the

EFQM excellence model was confirmed by just 26% , 17%, 5% and 20% of the

respondents in public, private, SSO and other groups of hospitals, respectively.

Approximately, 35% and 58% of the respondents in public and private hospitals

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respectively reported that they do not apply any QMS at their affiliated hospitals. Of

all respondents, 54% reported that TQM is not a current priority at their hospitals.

However, 62% of respondents in SSO’s hospitals reported using TQM as a QA

priority in their hospitals.

Discussion

Our study provides a unique insight into the extent of implementation and applied

mechanisms of the most common QA policies over the past decade in Iranian

hospitals. The study revealed that a cycle of four main mandatory and voluntary QA

methods have been implemented in Iranian hospitals; which forms a tight monitoring

system to assure the quality of care in hospitals. The licensing, annual evaluation and

grading, and regulatory inspections were statutorily implemented by the government

as a national package to assure the quality in the hospitals, while the implementation

of QMS was voluntarily for hospitals.

Forming a comprehensive quality assurance package

Continuous evaluation of quality is important to ensure that hospitals are accountable

to the public for their performance and quality of care. Currently there is a

combination of QA policies applied in the Iranian hospitals. In addition to obligatory

policies, a set of voluntary QMS policies forms the QA cycle in the Iranian hospitals.

ISO and EFQM are currently the most applied QMS conducted in the Iranian

hospitals. This has been supported by the recent recognition by the MOHME and SSO

of the suitability of EFQM and ISO models as quality policies. Farzianpour et al.

(2011) reported that many hospital managers are currently showing interest in

obtaining ISO and EFQM certificates.

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The existing combination of QA policies in Iran is partly conform international

studies which have reported similar approaches including licensing, standards,

guidelines, quality indicators, inspections, quality assessment and accreditation, as

well as QMS for QA and improvement in hospitals. Several studies of national policy

on quality development in health systems have identified a need for applying a

combination of statutory and voluntary policies to ensure quality of care and

accountability in hospitals (Øvretveit, 2003; Kaya, 2000; The standing committee of

the hospitals of the European Union, 1996; Mohammadi et al., 2007; Shaw, 2001 and

2003).

A continuous cycle of quality assurance activities

The cycle of QA policies starts with the institutional time-limited licensing before a

new hospital starts to operate. It continues with the performance of regulatory

frequent inspections, systematic performance measurement and annual evaluation,

extensive grading, and license renewal following a satisfactory on-site inspection.

These methods are completed with voluntary QMS to ensure and improve quality of

care in hospitals. Some other studies have also identified a continuous cycle of

performance measurement, valid standards, clinical guidelines, repeated measurement

and continuous improvement policies in hospitals in the past two decades. There are

some similarities in QA policies between the Iranian hospitals and those in other

countries. But, the extent and methods of implementation, legal requirements for QA,

standard setting process, funding, and policy incentives are substantially different

(Shaw, 2002).

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Role of government, professionals, and patients in implementing quality

assurance policies

Government

The QA procedure in Iran is mainly funded by the government to guarantee the

quality of care in hospitals. The government legislates the main QA policies and

provides resources for the conduction of the policies by involving the UMSHSs in the

implementation process. The UMSHSs have a strong role across the country in the

process by providing a supportive environment, standards, guidelines and technical

advice. Some studies revealed that legislation of QA policies and statutory supports

are major incentives for the implementation and effectiveness of the policies (Shaw,

2002; Emmy et al., 2001; Eldar and Ronen, 1995). The statutory steerage of activities

and a leadership role by the government is an important incentive and guarantees the

implementation of QA policies at national level (Mosadeghrad, 2014b). However,

such involvement by the governmental may not provide a credible independency and

validity of assessment (Shaw, 2004; Spencer and Walshe, 2009).

Professionals

The success of QA policies depends on the interest and involvement of the

professionals (including administrators, physicians, and nurses) working in the

hospitals (Tengilimoglu, 2013; Mosadeghrad, 2014a). In spite of the increasing

national interest in different QA policies, we did not find much contribution,

involvement or interest among the hospital professionals for the development and

implementation of the policies in Iran (Aghaei Hashjin et al., 2014c). As physicians,

nurses, quality improvement officers, and administrators play a minor (or no) role in

developing the QA policies. This may directly affect the effectiveness of the

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implementation of QA policies in hospitals. (StorageMart, 2013; Mosadeghrad,

2014a,b).

Patients

Several studies have identified that focusing on patients and patient surveys can

provide insight into the effectiveness and successful implementation of QA policies as

they can reflect the overall quality of hospital care provided (Mosadeghrad, 2014b;

Taner and Antony, 2006). The patient satisfaction measurement, patient safety,

consideration of patient values and expectations, and attention for patients’

complaints are the main potential outcomes of current QA policies in hospitals in Iran.

However, the real influence of the policies on patients needs to be further investigated

(Aghaei Hashjin et al., 2014b).

Effectiveness of applied policies

The compulsory system of hospital evaluation and performance measurement,

committees, quality indicators and national clinical guidelines has been reported as

important QA polices in the health care system (Shaw, 2002; Klazinga, 1996).

However, the effectiveness of the performance of these instruments is currently

unknown. It seems there is a need to investigate the impact of annual evaluations and

functioning of the hospital committees, methods of measuring indicators, reliability of

provided performance data, and the accuracy of clinical guidelines on the quality of

hospital care in Iran (Aghaei Hashjin et al., 2014a).

The effectiveness of the statutory inspections made by different authorized

organizations also calls for further investigation. Most of the inspections are

preventive rather than complaint-based investigations. Although inspections have

improved organizational performance of hospitals, there is some evidence that

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hospitals increase their compliance with the standards prior to the inspections. Such

(pressured) ad hoc quality improvements may not be the optimal way to achieve a

culture of continuous quality improvement in hospitals. Other studies reported the

same consequences of announced inspections (Shaw, 2004).

Although a variety of QA policies are being used in the Iranian hospital system,

no research has been conducted on assessing the effectiveness of one or more quality

policies that can be used to assure quality in the Iranian hospitals. Optimising the right

balance between the implemented policies seems a logical next step in the evolution

process of QA in Iran. In addition, it seems the currently ongoing repositioning and

maturing of the evaluation and performance measurement program towards an

accreditation program in Iranian hospitals is a positive move towards further

promoting the fulfillment of QA reguirements (MOHME, 2011). It is recommended

to also increase the focus on creating a supportive organizational culture at hospital

level to increase the uptake of quality improvement activities. The authors therefore

advocate further research focusing on the effectiveness of current QA policies and

related factors that may facilitate or hamper the implementation of hospital QA in

Iran.

Strengths and limitations

This is the first study providing insight into the currently applied QA policies in the

hospital sector in Iran. The comprehensive scope of the study, use of a national

sample of hospitals, and mixed method of a validated questionnaire survey and

document review, are strong features of the study design. However, limited access to

readily available information on the current QA policies, determining the validity of

original descriptive data and translation from the original language (Farsi) into

English were limitations of our study.

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Conclusions

The implemented cycle of QA policies forms a tight and comprehensive monitoring

system to assure the quality of care in hospitals using a combination of mandatory and

voluntary methods in Iran. The statutory legal requirement for hospitals to

continuously improve the quality of hospital care is an important incentive for the

implementation these policies. The government’s strong external role in steering of

QA policies has been a key factor for high implementation level of the policies by

hospitals in Iran. The ongoing repositioning of the current hospital evaluation

program into an accreditation system and activities to further mature the hospital

quality assurance system are positive movements that are recommended to be

continued. It is currently unknown what the optimal balance of the currently applied

QA policies would be. Further insight into the effectiveness of current QA policies

and related factors that may facilitate or hamper the implementation of hospital QA in

Iran will increase our knowledge on how to effectively improve the quality of care in

hospitals.

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References

Aghaei Hashjin A, Kringos DS, Manoochehri J, Aryankhesal A and Klazinga NS. (2014a)

Development and impact of the Iranian hospital performance measurement program.

BMC Health Services Research, forthcoming.

Aghaei Hashjin A, Kringos DS, Manoochehri J, Ravaghi H and Klazinga NS. (2014b)

Implementation of patient safety and patient-centeredness strategies in Iranian

hospitals. PLOS ONE, forthcoming.

Aghaei Hashjin A, Ravaghi H, Kringos DS, Ogbu UC, Fischer C, Azami SR and Klazinga

NS. (2014c), Using Quality Measures for Quality Improvement: The Perspective of

Hospital Staff. PLOS ONE, January 23, 2014, DOI: 10.1371/journal.pone.0086014.

Berwick, D.M., James, B. and Coye, M.J. (2003), Connections between quality measurement

and improvement. Medical Care, 41: I30-I38.

Cohen, A.B., Restuccia, J.D., Shwartz, M., Drake, J.E., Kang, R., Kralovec, P., Holmes, S.,

Margolin, F. and Bohr, D. (2008), A survey of hospital quality improvement

activities. Medical Care Research and Review, 65: 571-595.

Eldar, R. and Ronen, R. (1995), Implementation and evaluation of a quality assurance

programme, International Journal of Health Care Quality Assurance, Vol. 8 No. 1,

pp. 28-32.

European Parliament. (2011), Directive 2011/24/EU of the European Parliament and of the

Council on the application of patients' rights in cross-border healthcare. 2011/24/EU.

Farzianpour, f., Aghababa, S., Delgoshaei, B., and Haghgoo, M. (2011), Performance Evaluation a

Teaching Hospital Affiliated to Tehran University of Medical Sciences Based on

Baldrige Excellence Model, American Journal of Economics and Business

Administration 3 (2): 277-281.

Greenfield, D. and Braithwaite, J. (2008), Health sector accreditation research: a systematic

review. International Journal for Quality in Health Care, 20: 172-183.

Gani, A. (1996), Improving quality in public sector hospitals in Indonesia, The International

Journal of Health Planning and Management, Volume 11, Issue 3, pages 275–296.

Groene, O., Klazinga, N., Wagner, C., Arah, O.A., Thompson, A., Bruneau, C. and Sunol, R.

(2010), Investigating organizational quality improvement systems, patient

empowerment, organizational culture, professional involvement and the quality of

care in European hospitals: the 'Deepening our Understanding of Quality

Improvement in Europe (DUQuE)' project. BMC Health Services Research, 10: 281.

Groene, O., Klazinga, N., Walshe, K., Cucic, C., Shaw, C.D. and Sunol, R. (2009), Learning

from MARQuIS: future direction of quality and safety in hospital care in the

European Union. Quality and Safety in Health Care, 18 Suppl 1: i69-i74.

Page 46 of 51International Journal of Health Care Quality Assurance

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960

Page 48: QA policies article submitted in the IJHCQA (Dr. Manoochehri)

For Peer Review

- 21 -

Groene, O., Lombarts, M.J., Klazinga, N., Alonso, J., Thompson, A. and Sunol, R. (2009), Is

patient-centredness in European hospitals related to existing quality improvement

strategies? Analysis of a cross-sectional survey (MARQuIS study). Quality and Safety

in Health Care, 18 Suppl 1: i44-i50.

HOPE (The standing committee of the hospitals of the European Union). 1996. The quality of

hospital care in the European Union, Leuven.

JCI (Joint Commission International). (2014), Number of hospitals accreditted by JCI.

http://www.jointcommissioninternational.org/about-jci/jci-accredited-organizations/

accessed March 2014.

Kaya, S. (2000), Developing a quality management program for the ministry of health

hospitals in Turkey, Takemi program in international health, Harvard School of

Public Health, USA.

Klazinga, N. (1994), Concerted action programme on quality assurance in hospitals 1990-

1993 (COMAC/HSR/QA). Global results of the evaluation. International Journal of

Health Care Quality Assurance, 6: 219-230.

Klazinga, N. (1996), Implementing clinical guidelines in hospitals and acute care settings. A

European perspective: context, content and consequences of practice guidelines in

European hospitals.

Legido-Quigley, H., McKee, M., Walshe, K., Sunol, R., Nolte, E. and Klazinga, N. (2008),

How can quality of health care be safeguarded across the European Union? British

Medical Journal, 336: 920-923.

Lombarts, M.J., Rupp, I., Vallejo, P., Klazinga, N. and Sunol, R. (2009), Differentiating

between hospitals according to the "maturity" of quality improvement systems: a new

classification scheme in a sample of European hospitals. Quality and Safety in Health

Care, 18 Suppl 1: i38-i43.

MARQuIS project consortium. (2009), The MARQuIS Questionnaire.

http://www.marquisquestionnaire.nl/marquis/index.asp, accessed July 2009.

McGlynn, E.A., Asch, S.M., Adams, J., Keesey, J., Hicks, J., DeCristofaro, A. and Kerr, E.A.

2003. The quality of health care delivered to adults in the United States. The New

England Journal of Medicine, 348: 2635-2645.

Mehrdad, R. (2009), Health System in Iran. Journal of the Japan Medical Association, 52:

69-73.

Mohammadi, S.M., Mohammadi, S.F., Hedges, J.R., Zohrabi, M. and Ameli O. (2007),

Introduction of a quality improvement program in a children's hospital in Tehran:

design, implementation, evaluation and lessons learned. International Journal of

Health Care Quality Assurance, 19: 237-243.

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For Peer Review

- 22 -

MOHME. (1996), Department of accrediation and standards of general hospitals. Teheran,

Iran.

MOHME. (2002), Practical instruction to quality evaluation in hospitals (in Farsi), The

Ministry of Health and Medical Education, Tehran, Iran.

MOHME. (2009), The trend of changing general hospitals’ grades from 2005 to 2008.

MOHME. (2011), Hospital Accreditation Standards in Iran.

Mosadeghrad, A M. (2014a) "Essentials of Total Quality Management: A Meta-Analysis",

International Journal of Health Care Quality Assurance, Vol. 27 Iss: 6.

Mosadeghrad, A M. (2014b) "Why TQM does not work in Iranian healthcare organisations",

International Journal of Health Care Quality Assurance, Vol. 27 No: 4.

Øvretveit, J. (2003), What are the best strategies for ensuring quality in hospitals?

Copenhagen, WHO Regional Office for Europe Health Evidence Network (HEN).

Øvretveit, J. (1997), Would it work for us? Learning from quality improvement in Europe

and beyond. The Joint Commission Journal on Quality Improvement; 23 (1): 7-22.

Preker, A.S. and Harding, A. (2003), Innovations in health service delivery: The

corporatization of public hospitals. The World Bank, Washington DC.

Restuccia, J.D. and Holloway, D.C. (1982), Methods of control for hospital quality assurance

systems. Health Services Research, 17: 241-251.

Shaw, C.D. and Kalo, I. (2002), A background for national quality policies in health systems,

WHO Regional Office for Europe, Copenhagen, Denmark.

Shaw, C.D., Kutryba, B., Crisp, H., Vallejo, P. and Sunol, R. (2009), Do European hospitals

have quality and safety governance systems and structures in place? Quality and

Safety in Health Care, 18 Suppl 1: i51-i56.

Shaw, C.D. (2001), External assessment of health care. British Medical Journal, 322: 851-

854.

Shaw, C.D. (2000), External quality mechanisms for health care: summary of the ExPeRT

project on visitatie, accreditation, EFQM and ISO assessment in European Union

countries. External Peer Review Techniques. European Foundation for Quality

Management. International Organization for Standardization. International Journal of

Health Care Quality Assurance, 12: 169-175.

Shaw, C.D. (2003), How can hospital performance be measured and monitored? WHO

Regional Office for Europe (HEN Network, Copenhagen, Denmark.

Shaw, C.D. (2004), The external assessment of health services. World Hospitals and Health

Services, 40: 24-7, 50, 51.

Page 48 of 51International Journal of Health Care Quality Assurance

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960

Page 50: QA policies article submitted in the IJHCQA (Dr. Manoochehri)

For Peer Review

- 23 -

Spencer, E. and Walshe, K. (2009), National quality improvement policies and strategies in

European healthcare systems. Quality and Safety in Health Care, 18 Suppl 1: i22-i27.

SSO (Iranian Social Security Organization). (2008), The Group of Indicators Survey.

Teheran, Iran.

StorageMart. (2013), http://www.totalqualityassuranceservices.com/establishing-hospital-

quality-assurance-programs/ Accessed 15-05-2013.

Sunol, R., Garel, P. and Jacquerye, A. (2009), Cross-border care and healthcare quality

improvement in Europe: the MARQuIS research project. Quality and Safety in Health

Care, 18 Suppl 1: i3-i7.

Sunol, R., Vallejo, P., Groene, O., Escaramis, G., Thompson, A., Kutryba, B. and Garel, P.

(2009), Implementation of patient safety strategies in European hospitals. Quality and

Safety in Health Care, 18 Suppl 1: i57-i61.

Tabriz University of Medical Sciences. (2012), http://treatment.tbzmed.ac.ir/, accessed

November 2012.

Taner T and Antony J. (2006), Comparing public and private hospital care service quality in

Turkey, Int J Health Care Qual Assur Inc Leadersh Health Serv.19(2-3):i-x.

Tengilimoglu, D., Celik, Y., Akbolat, M., Isik, O. and Kurtuldu, A. (2013), Asssessment of

Health Administration Education: A Field Practice in Turkey. J. Asian Dev. Stud, Vol. 2, Issue 1.

Wagner, C., Gulacsi, L., Takacs, E. and Outinen, M. (2006), The implementation of quality

management systems in hospitals: a comparison between three countries. BMC Health

Services Research, 6: 50.

Weiner, B.J., Alexander, J.A., Shortell, S.M., Baker, L.C., Becker, M. and Geppert, J.J.

(2006), Quality improvement implementation and hospital performance on quality

indicators. Health Services Research, 41: 307-334.

WHO. (2011), Country Cooperation Strategy for WHO and the Islamic Republic of Iran

20120-2014. EM/ARD/038/E. Regional Office for the Eastern Mediterranean. Cairo.

WHO. (2004-2005), Eastern Mediterranean Regional Office (EMRO), Division of Health

System and Services Development, Health Policy and Planning Unit,

http://gis.emro.who.int/HealthSystemObservatory/PDF/InstrumentsAndTools/

Glossary.pdf, accessed May 2013.

WHO. (2003), Evidence and Information for Policy, Department of Health Service Provision,

Geneva.

WHO. (2006), Health Systems Profile- Lebanon Regional Health Systems Observatory-

Regional Office for Eastern Mediterranean (EMRO),

http://gis.emro.who.int/HealthSystemObservatory/PDF/Lebanon/FullProfile, accessed

May 2013]

Page 49 of 51 International Journal of Health Care Quality Assurance

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960

Page 51: QA policies article submitted in the IJHCQA (Dr. Manoochehri)

For Peer Review

- 24 -

WHO. (2006), Health Systems Profile- Saudi Arabia Regional Health Systems Observatory-

Regional Office for Eastern Mediterranean (EMRO),

http://gis.emro.who.int/HealthSystemObservatory/PDF/SaudiArabia/Full Profile,

accessed May 2013.

WHO. (2012), Health Systems Profile: Islamic Republic of Iran. Regional Health Systems

Observatory WHO (EMRO), Cairo.

Zaim, H, Bayyurt, N, Zaim, S. (2010), Service Quality And Determinants Of Customer

Satisfaction In Hospitals: Turkish Experience. International Business & Economics

Research Journal – May 2010 Volume 9, Number 5.

Zarenejad, A. and Akbari, M. (2009), A report on 30 years performance of the Iranian

Ministry of Health and Medical Education (MOHME). Teheran, Iran.

Table I - The coverage and mechanism of implementation of quality assurance

policies in Iranian hospitals (n=84)

Note:

QA: Quality assurance

EFQM: European Foundation for Quality Management

TQM: total quality management

ISO: International Organization for Standardization

Mechanism and coverage of implementation by type of hospital

QA Policies

Mandatory

% (n)

Voluntary

% (n)

Govern-

ment

hospitals

Private

hospitals

SSO

hospitals

Other

hospitals

Govern-

ment

hospitals

Private

hospitals

SSO

hospitals

Other

hospitals

Licensure, annual evaluation and

inspections

100 (46) 100 (12) 100 (21) 100 (5) 0 0 0 0

Quality

management

systems (QMS)

ISO - - 100 (21) - 28 (13) 25 (3) 0 80 (4)

EFQM - - - - 26 (12) 17 (2) 5 (1) 20 (1)

Other - - - - 11 (5) 0 0 0

None - - - - 35 (16) 58 (7) 95 (20) 0

TQM

(as a QA priority in

hospital)

1st priority - - - - 15 (7) 8 (1) 19 (4) 0

2nd priority - - - - 4 (2) 0 24 (5) 0

3rd priority - - - - 28 (13) 25 (3) 19 (4) 20 (1)

No priority - - - - 53 (24) 67 (8) 38 (8) 80 (4)

Page 50 of 51International Journal of Health Care Quality Assurance

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Page 52: QA policies article submitted in the IJHCQA (Dr. Manoochehri)

For Peer Review

Table I - The coverage and mechanism of implementation of quality assurance

policies in Iranian hospitals (n=84)

Note:

QA: Quality assurance

EFQM: European Foundation for Quality Management

TQM: total quality management

ISO: International Organization for Standardization

Mechanism and coverage of implementation by type of hospital

QA Policies

Mandatory

% (n)

Voluntary

% (n)

Govern-

ment

hospitals

Private

hospitals

SSO

hospitals

Other

hospitals

Govern-

ment

hospitals

Private

hospitals

SSO

hospitals

Other

hospitals

Licensure, annual evaluation and

inspections

100 (46) 100 (12) 100 (21) 100 (5) 0 0 0 0

Quality

management

systems (QMS)

ISO - - 100 (21) - 28 (13) 25 (3) 0 80 (4)

EFQM - - - - 26 (12) 17 (2) 5 (1) 20 (1)

Other - - - - 11 (5) 0 0 0

None - - - - 35 (16) 58 (7) 95 (20) 0

TQM

(as a QA priority in

hospital)

1st

priority - - - - 15 (7) 8 (1) 19 (4) 0

2nd

priority - - - - 4 (2) 0 24 (5) 0

3rd

priority - - - - 28 (13) 25 (3) 19 (4) 20 (1)

No priority - - - - 53 (24) 67 (8) 38 (8) 80 (4)

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