Retrospective Review of a Product or a Service Is What in Health Information

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A retrospective review of how nonconformities are expressed and finalized in external inspections of health-care facilities

BMC Health Services Inquiry volume 15, Article number:405 (2015) Cite this commodity

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Abstruse

Background

External inspections are widely used in health care as a means of improving the quality of care. Still, the manner external inspections affect the involved system is poorly understood. A better understanding of these processes is important to improve our understanding of the varying effects of external inspections in dissimilar organizations. In plow, this tin contribute to the evolution of more effective means of conducting inspections. The way the inspecting organization states their grounds for noncompliant beliefs and later follows upwardly to enforce the necessary changes can have implications for the inspected system's change process. We explore how inspecting organizations limited and state their grounds for noncompliant behavior and how they follow up to enforce improvements.

Methods

We conducted a retrospective review, in which we performed a content analysis of the documents from 36 external inspections in Norway. Our assay was guided by Donabedian's structure, process, and upshot model.

Results

Deficiencies in the direction system in combination with clinical work processes was considered as nonconformity by the inspecting organizations. 2 characteristic patterns were identified in the way observations led to a statement of nonconformity: 1 in which it was clearly demonstrated how deficiencies in the management organization could affect clinical processes, and one in which this connexion was non demonstrated. Two characteristic patterns were also identified in the fashion the inspecting organization followed upward and finalized their inspection: one in which the inspection was finalized solely based on the documented changes in structural deficiencies addressed in the nonconformity statement, and i based on the documented changes in structural and procedure deficiencies addressed in the nonconformity argument.

Conclusion

External inspections are performed to amend the quality of care. To accomplish this aim, we suggest that nonconformities should be grounded by observations that clearly demonstrate how deficiencies in the direction system might impact the clinical processes, and that the inspection should exist finalized based on documented changes in both structural and process deficiencies addressed in the nonconformity statement.

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Groundwork

External inspection systems in which a health-intendance organization's operation is assessed according to an externally defined standard are widely used [i]. This activity is a cadre chemical element in regulatory regimes and in certification and accreditation processes [2, three]. Assessing a health-care organization's functioning according to external standards has been described by partly overlapping terms such as external inspection, external review, supervision, and audit [iv, 5]. In line with Flodgren et al. [6] we will use the term "external inspection" defined past Walshe equally, "a organisation, process or arrangement in which some dimensions or characteristics of a healthcare provider system and its activities are assessed or analyzed against a framework of ideas, knowledge, or measures derived or developed outside that organization" [vii]. The inspection itself is initiated and controlled by an external organization.

The widespread use of external inspections is based on the assumption that they can contribute to better the quality of care [8]. Previous inquiry has found that external inspections in wellness care can provide the inspected organizations with useful information for their initiatives and efforts to improve their quality of care [9, 10]. External inspections seem to affect organizational exercise, but in that location is sparse knowledge about how and if such changes in organizational practice lead to improved quality of care [11–13].

The manner external inspection systems bear upon the involved organization is poorly understood [6, 11, 14, 15]. A better agreement of these processes is important to improve our understanding of why effects of external inspections seem to vary between organizations. In turn, this tin facilitate development of more than constructive means to deport inspections [six]. It can also help united states of america develop well-designed studies to appraise the effects of external inspection systems [12].

One of the cadre purposes of an external inspection is to contribute to improving quality of care. Quality of care is not a uniquely divers concept. From the patient's perspective, quality of care is highly dependent on how providers mutually interact to provide high-quality services [16, 17]. Quality of care can thus exist considered a property of the wellness-care system that is dependent on how the services perform as a whole [18]. Accordingly, improving the quality of care is dependent on irresolute the performance of the system, which in turn implies change in organizational behavior. A basic precondition for external inspections is that the inspected organization is accountable for making necessary changes when nonconformities are encountered. Therefore, the key to improving our understanding of how external inspection might affect the quality of care is to explore how it tin facilitate changes in organizational behavior.

Different theoretical frameworks such every bit institutional theory, public pick theory, and principal agent theory have been suggested as starting points for exploring the effects of regulation and inspection [8]. Our objective is to explore how a core element in a regulatory regime, inspections, can contribute to improve the quality of care. In line with recommendations by Walshe and Boyd [8] we used a framework developed by Hood et al. [xix] considering information technology operationalizes the core activities involved in the inspection procedure. The framework describes three phases of a regulatory regime: direction, detection, and enforcement. Direction refers to deportment taken at a organisation level aiming to affect all the regulated organizations, e.g. developing health-care legislation and national guidelines for delivery of care. Detection refers to actions directed towards individual organizations, due east.g. inspecting an organisation'southward performance in a particular surface area in relation to standard regulatory requirements. Enforcement comprises actions taken at the private organizational level to change their operation to comply with the legal requirements, due east.g. when the inspecting organization follows up to make sure that necessary changes are implemented when nonconformities are encountered during an inspection. Separating the assessment stage undertaken by an external body from the post-obit enforcement phase where the inspected organization is accountable for implementing necessary changes as well complies with the international requirements for inspection standards [20]. For our purpose, merely the detection and enforcement phases are relevant because standard setting precedes the actual inspection.

We suggest that elements of these two phases are important to facilitate organizational behavior modify. The assessment phase can reveal nonconformities that the inspected arrangement is obliged to address. During the enforcement phase, the inspecting organization tin follow upwards to make sure that the implemented measures are effective in correcting the nonconformity. The way the inspecting organization states their grounds for noncompliant behavior and subsequently follows up to ensure that the inspected organization implements the necessary changes can accept implications for the inspected organization's change process. We were unable to identify enquiry that specifically addressed how nonconformities are expressed, grounded, and followed up in a health-care setting. The aim of this article is to explore how inspecting organizations in Norway express and state their reasons for nonconforming behavior and how they subsequently follow up the inspected organizations.

Context

Walshe et al. [five] described proposed approaches to external inspections using the following dimensions: purpose, organization, overall approach, methods, and results. In the following, nosotros will describe inspections in Norway using these dimensions. The Norwegian Board of Wellness Supervision is a national public institution organized under the Ministry of Health and Care Services that is mandated by the Norwegian Parliament to ensure that wellness-care and social services are provided in accord with legal requirements. The Lath prioritizes and suggests areas for nationwide inspections based on information well-nigh risk and vulnerability. Xviii county governor offices perform the actual inspections on behalf of the Board.

The standards used for inspections in health-care services are grounded in the legislation laid out in acts and regulations. The legislation is based on 2 main pillars: health-care services should be safe and effective and provided in accordance with sound professional standards. Furthermore, all organizations that provide health-care services are required to take a direction system to ensure that health-care services are provided in accordance with legal requirements. National clinical guidelines provide requirements that are more than specific. The rules and regulations that apply for a particular service area are operationalized by the Lath into criteria relevant for clinical practice prior to the inspection.

There are two main categories of health-care organizations inspected in Kingdom of norway: hospitals and municipalities. They provide different kinds of health-care services and represent different types of organizations. The majority of Norwegian hospitals are publicly owned. The hospitals by and large represent larger organizations than the municipalities and they provide specialized care. Furthermore, they have a potent hierarchical structure; they are endemic past the authorities and are operated through regional health trusts, which provide a common superstructure. Each municipality represents an independent entity responsible for providing chief health-care services for its inhabitants.

System revision is the main method used to inspect the services in Kingdom of norway [20]. The inspecting body examines documents, interviews leaders and health-care personnel, and reviews patient records and relevant performance data. After the inspection, an inspection report detailing the findings is delivered to the inspected organization. If the legal requirements are non met, the findings are expressed as a statement of nonconformity. This statement is supported by a number of observations or findings that exemplify why the requirements were not met. The inspecting county governors are also mandated to follow up the inspected organizations until the legal requirements are met.

Methods

Design

We conducted a systematic literature review to identify research almost how inspecting organizations describe nonconforming behavior and how they follow upwardly the inspected organizations. Flodgren et al. [half dozen] developed a systematic search to identify empirical studies on the effectiveness of external inspections in health care. We used their search strategy every bit a starting point, modified their search to include qualitative studies, and searched the Cochrane Central Register of Controlled Trials (CENTRAL), Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effectiveness, MEDLINE, EMBASE, CINAHL, Psych INFO, and Web of Scientific discipline (1980 – December 2014). We did non identify research that specifically addressed how nonconformities in health care are expressed, grounded, and followed up. Therefore, we decided to conduct a qualitative, explorative review.

Information drove

We used purposive sampling because the objective of our review was explorative [21]. In March 2014, we wrote a letter to the xviii canton governor offices in Norway and asked them to send the states the correspondence of two recently finalized inspections for review. The two inspections should take encountered nonconformities; one of the inspections should be conducted within specialized care and the other in primary care. We requested the inspection report and the following interchange of documents between the inspection bureau and the inspected organization until the inspection was finalized. In the cases where the documentation nosotros received from the county governors was incomplete, nosotros approached them once more until our data set up was consummate. The inspections were carried out during 2011–2013 and finalized during 2013–2014.

Analysis

Our data consisted of written documents. We imported the documents to Nvivo and performed a content analysis using a combination of a direct and indirect approach, as described by Hsieh and Shannon [22] past combining coding derived from a predefined theoretical framework and codes derived from the data.

In line with the recommendation by Walshe and Boyd [eight], nosotros used Donabedian's [23] structure, process, and issue model every bit a theoretical framework to guide our analysis of the content of the nonconformity statements, their corresponding observations, and the inspected organization'south measures to address the nonconformities. Donabedian's structure, process, and effect model helps to obtain a better understanding of the preconditions for improving organizational performance and thereby the quality of intendance. Construction refers to the organizational prerequisites for delivering health services, e.g. buildings, economical and human resources, competence, and infrastructure. The organization's management system, which is used to control and clinch the quality of the services, can be considered part of the structure. Process denotes what is really done in providing care [23], and issue is the effect health-care services have on the health status of individuals and populations. Donabedian [23] suggested that construction, process, and outcome are linked through an underlying framework. The quality of the outcomes can thus be understood every bit a production of the quality of the structural elements and the processes [23]. Appropriately, the quality of the outcomes can exist improved by irresolute the structures, the processes, or a combination of the two [23].

All researchers independently read samples of the documents and thereafter discussed and agreed on an initial coding scheme, which included the nonconformity statement, observations grounding the nonconformity statement, inspecting organization's follow-up procedure, measures initiated to right nonconformity, and finalization of inspection. HH and EH independently coded the documents and added more detailed codes derived from the documents, e.g. specific content of different observations grounding the nonconformity statements and content of measures initiated to correct nonconformities. EH and GSB independently coded the content of the nonconformity statements, the observations, and the measures according to the 3 domains in our theoretical framework: construction, process, and outcome. Throughout the procedure of coding, the researchers discussed and compared codes to reach a consensus. Using an iterative process of coding, reflecting on the codes, and condensing, we identified common themes and patterns displaying how the inspecting organization grounded the nonconformities and followed up to ensure that they were dealt with [24].

Ethical considerations

The protocol of the study was presented to the Norwegian Social Science Data Service, and a formal ethical review was not deemed necessary because all the documents were publicly available and did not incorporate whatever kind of personal sensitive information.

Results

We analyzed the documents of the correspondence between the inspecting and inspected organizations in 36 inspections: eighteen from specialized care and 18 from primary intendance. Based on our analysis we identified the following themes: content of nonconformity statement, content patterns in observations grounding the nonconformity statement, measures to right nonconformity, and inspection finalization patterns. Table 1 shows the number of inspections for each inspection theme and the frequencies for the patterns nosotros identified. We presented our findings according to the two principal phases of the inspection: the assessment and enforcement phases.

Table 1 Number of inspection themes and pattern frequencies

Full size table

Assessment phase

The most commonly used nonconformity statements referred to deficiencies in a combination of structure and process elements in Donabedian's model. The structural elements of the nonconformity statement typically addressed deficiencies in the inspected organization'due south management system, and the process element referred to either clinical processes or a support processes. Generically, it can be expressed in a formula: organisation x does not have a management organization that adequately ensures that process y is in accordance with the requirements. The example beneath illustrates a nonconformity statement for a hospital:

"Infirmary A has not established a organization for ensuring that patients are assessed and diagnosed co-ordinate to sound professional practice."

A small minority of the nonconformity statements solely addressed structural or process elements, eastward.g. lack of competence or deficiencies in the delivery of a specific wellness-care service. We did not place nonconformity statements that addressed result elements in Donabedian's model.

The nonconformity statements were grounded in observations based on information obtained during the inspection, e.thou. documents, interviews with personnel and leaders, patient records, or information from the patient administrative system. There was a high degree of coherence between the observations and the nonconformity argument in the sense that they supported and elaborated the grounds for the nonconformity. The observations addressed deficiencies in structure and process elements or a combination of the two. As for the nonconformity statements, the observations apropos structural deficiencies mainly addressed the direction organisation, while deficiencies in process concerned clinical or back up processes. Three of the nearly frequently used themes for observations concerning deficiencies in the management organization concerned written guidelines, education, and discrepancy reports.

Nosotros identified two patterns characterizing how these observations contributed to support the grounds for the nonconformity argument. In the first pattern, observations draw deficiencies in the direction arrangement, but they practise not explicitly display or have any reference as to how the deficiencies in the management organisation might affect the clinical processes. The observations for Municipality A and Infirmary B illustrate the first pattern:

Municipality A

"No external or internal education related to diet has been undertaken, and the need of competence related to this topic has not been evaluated. The organization has an inadequate system for dealing with discrepancy reports. In the nursing home, there is a file for storing discrepancy reports, merely the number of reports is low. Through the interviews, we found that the employees exercise not become feedback from the direction related to how discrepancy reports are handled."

Hospital B

"The guidelines regarding the referral of patients within the wellness trust is unclear and inadequate."

In the 2d pattern, the observations clearly brandish how deficiencies in the management system and support processes might affect the clinical processes as illustrated past the post-obit example in which the clinical processes were not conducted in accordance with the national guidelines:

Municipality B

"Preventive wellness care for children does not routinely perform the activities described in national clinical guidelines. Control at 17–18 months of age is non performed. We did not discover any documentation describing why this activity had been omitted. The answerable leader in the municipality has not discovered by means of the direction system that the program for and performance of the health controls are not compatible with national clinical guidelines. Therefore, no action had been implemented to right this nonconformity."

Nosotros did not identify observations that addressed the outcome domain in Donabedian'south model. Many of the inspection reports contained a section in which the inspecting arrangement assessed the inspected organization's management organization. In 1 of these, we identified a description of the importance of using effect information to evaluate the arrangement's performance:

Hospital C

"It is a major challenge to obtain operational information, e.thousand. information that tin be used to evaluate the consequence of provided handling. It is of import that this kind of data is available for managers also every bit clinicians then that right decisions can be made. This kind of data is important for planning besides as evaluation of the services. Equally it stands now, it may exist hard to evaluate the performance of this department as required by the regulations relating to internal control of the organizations performance."

Enforcement phase

In a document accompanying the inspection written report, the canton governors requested information about how the inspected organization should follow up the nonconformities that had been encountered. The county governors used standardized diction for this request describing the plan of activity with time limits for the whole correction process, measures to right the nonconformities, direction's surveillance of implementation of measures, and management's assessment of the effect of the implemented measures.

The inspected organization typically responded to this request by developing an overall program of action with time limits describing when unlike measures aimed at correcting the nonconformity should be implemented. The most ordinarily used measures addressed the structural office of the nonconformity argument, e.g. developing or revising written guidelines describing how a specific process should exist carried out along with information and instruction to involved personnel. Other measures that we identified were alter in organization and distribution of responsibility, and raising awareness of the importance of filing and following up internal discrepancy reports. The following examples illustrate some of the measures:

Hospital D

"The guideline for dealing with referrals has been canonical, and the department has conducted education activities with regard to this guideline. The department has educated all the secretaries regarding the guidelines for managing the waiting lists and how to bargain with breaches of maximum adequate waiting times. Two follow-up courses are planned annually."

The inspected organization's initial cess of the caste of implementation and the effect of the implemented measures was more often than not vague and relied on qualitative judgments. In many cases, particularly in primary care, there was no assessment of effects of measures, but rather a belief that a new written guideline lonely would alter the practice, as illustrated in the following example:

Municipality C

"The follow up past the managerial team of the municipality to ensure that patient records contain necessary and relevant information is organized in this way. The managing director of the section is responsible for elaborating a guideline describing the content of the patient records. This guideline shall be sent to the head of the section of health and social services for approval. When appointment of revision is reached, the guideline shall be evaluated and sent again for approval by the head of the department of health and social services."

We identified two distinct patterns equally to how the county governors subsequently followed up and finalized the inspections. The first pattern was characterized by the inspection beingness finalized solely based on documented changes in structural elements addressed in the nonconformity argument. Typically, the inspected organisation would revise or develop new written guidelines and provide educational activities for their staff. However, there was no evaluation of whether such changes affected the processes. This design is illustrated by the findings from municipality D, which showed nonconformity related to the preparation and dispensing of medication.

Municipality D

"The new guidelines with attached procedures were discussed with leaders on different managerial levels at mean solar day seminars to make each leader aware of their responsibilities. The personnel in accuse of dispensing medicines from prepared medicine boxes to patients were given internal training according to the procedures established by the municipality. This measure is followed upward continuously."

In the case illustrated higher up, the county governor finalized the inspection based on documentation of implemented measures aimed at improving structural elements, without documentation of whether the measures affected the processes.

In some of the inspections following this blueprint, the county governor requested more than documentation of the consequence of the measures, but received just qualitative judgments, as illustrated by the following example:

Municipality E

"Finally, we will say that the implemented measures have been shown to exist effective. The personnel too as the managers are more than aware about the requirements in chapter 4A of the deed regarding the rights of the patients. Nosotros accept to continue working with documentation in patient records and evaluate to what extent we have made relevant judgments regarding decisions according to chapter 4A."

A more thorough and meticulous follow up procedure characterized the second pattern that nosotros identified for finalizing inspections. In cases post-obit this pattern, the canton governors did not finalize the inspection until the inspected organization had properly documented that expedient measures had been implemented to correct both the structural and the procedure elements of the nonconformity statement. This pattern is illustrated by the findings from Hospital Due east, which showed nonconformity related to the handling of stroke patients.

Hospital E

"All guidelines will be collected, evaluated, updated, and coordinated with the other infirmary in the wellness trust. Nosotros shall institute a organization of quality indicators for measuring the result of stroke treatment."

The county governor requested additional data about the effects of the planned measures, and the quotes below illustrate the central content of the hospital's answer.

"Using the Global Trigger Tool (GTT) method, we want to analyze five patients every month with the diagnoses I63–I64 and retrospectively evaluate the patient records. In addition, it is worth mentioning that nosotros have had ii audits using our adjusted GTT method. Both of them showed satisfying follow upwardly related to acute treatment and information letters to the municipal health services. Yet, we discovered one deviation related to some patients lacking National Institute of Wellness Stroke Scale (NIHSS) registration in the admission unit of measurement."

In the case illustrated higher up, the county governor besides received documentation well-nigh several rounds of patient record reviews using the adjusted GTT method, which demonstrated an comeback in process measures. By obtaining process information and reflecting on it, clinicians became aware of undesirable variation, which prompted them to take activeness to improve their clinical process. Based on this information, the county governor finalized the inspection. This pattern was the near dominant for finalizing inspections carried out in specialized care.

Give-and-take

Our main findings relate to how nonconformities are expressed in the assessment phase and followed upward in the enforcement phase. We structure our discussion effectually these 2 phases.

Assessment phase

In line with previous research, nosotros found that the nonconformities identified in external inspections addressed deficiencies in the management system, back up processes, and clinical processes, but not clinical outcomes [11, 25–27]. The standards used for inspections in our case study are based on requirements in Norwegian legislation, which do not contain specific issue requirements. Accordingly, we would not expect to come across nonconformity statements dealing with the outcome domain in our theoretical framework.

The cadre activity of health-intendance organizations is to deliver high-quality health-care services in accordance with the legal requirements, and the main purpose of the arrangement's management system and respective support processes is to ensure that the organization'south clinical processes are in accordance with sound professional standards. We found that many of the observations addressed deficiencies in the management system and the support processes. Power [28] suggested that, "if auditing processes get decoupled from cadre organizational activities, these effects may be minimal and the audit process becomes an expensive but harmless ritual, which is of import for external legitimacy." Benson et al. [11] found that the corrective measures that addressed deficiencies in support processes had limited issue on patient care, and in line with Power [26], they country that when the feedback business organization system processes in general, the intended benefit for the patients should exist made clear. We identified two general patterns for how the observations supported the nonconformities: one in which the observations regarding the direction system did not explicitly demonstrate how they affected the clinical processes, and 1 in which they did. Clinicians need an agreement of the reasons for why modify is needed [29]. In line with Power [28] and Benson et al. [eleven], we propose that observations that clearly demonstrate how deficiencies in the management organisation and its respective support processes affect the clinical processes are more likely to be understandable for clinicians. Consequently, we advise that it is more likely that such observations can contribute to the implementation of organizational change. This view is likewise supported by findings from Hilarion et al. [30], who found that using consensus-based indicators every bit part of external assessment helped to involve professionals in identifying necessary improvement deportment.

We did not identify any observations that explicitly addressed the outcome domain in our analytic framework. Full general comments in a few inspection reports addressed the fact that performance data was not used to assess performance. Admission to relevant data about functioning, understood as the outcome of the clinical processes, is a key component of a functional management system. Given the fact that almost of the nonconformity statements addressed deficiencies in the management system, it is thought provoking that we did not identify whatsoever observations addressing the absence of use of performance data to evaluate the outcomes of the clinical processes.

Enforcement stage

1 of the core purposes of an external inspection is to contribute to improvement of the quality of care. According to our analytic framework, improving outcomes is dependent on making changes and improvements in structures and processes. Nonconformities in our review study did generally accost a combination of deficiencies in structure and process elements. We identified 2 patterns for how inspections were followed up and finalized: i pattern in which the inspection was finalized solely based on documented changes in structural deficiencies addressed in the nonconformity argument, and ane pattern where changes were documented for both structural and process deficiencies addressed in the nonconformity statement.

When inspections were finalized based on changes in structural deficiencies the inspected organizations typically implemented changes in the management system, e.g. written guidelines and educational activities. Our data do not provide insight into how such measures afflicted clinical processes and outcomes. Previous research has shown that teaching and data activities take express and short-term effects on outcomes [31], and that it takes considerable effort to transform new written guidelines into changes in clinical exercise [32]. Therefore, information technology can be questionable to what extent the most frequently used measures were suited to improve clinical processes and the quality of care. The nonconformities and the supporting observations in our fabric indicated that the inspected organizations had deficiencies in having a functional management system. This is in line with previous research showing that management systems are not e'er systematically implemented and that information technology is questionable to what degree they actually support clinical piece of work [25, 33]. Accordingly, if cosmetic measures solely address structural deficiencies in the management system, there is an inherent risk that the changes have limited impact on the quality of care.

The second pattern for finalizing inspections was characterized by documented changes in the structural and procedure deficiencies addressed in the nonconformity statement. Similarly, to the kickoff pattern, the inspected organizations initially implemented measures aimed at correcting the structural deficiencies addressed in the nonconformity statement, e.g. written guidelines. Such guidelines specify how a clinical process should be carried out. In the second design, the county governor continued to request an evaluation of the upshot of the implemented measures using data that could brandish to what extent the clinical processes in fact were carried out as specified in the new guidelines.

Access to relevant process data is a basic precondition for quality comeback because they display to what extent improvement efforts are implemented [34]. Procedure data tin can make clinicians enlightened of deficiencies and variations in how the clinical processes are carried out. By requesting process data, the county governor contributed to the shifted focus from merely describing how the clinical process should be carried out to how it actually was carried out. We found that when clinicians reflected on procedure information, they became aware of variation in the clinical process, e.g. not performing NIHSS registration before treatment. Measuring the process was a prerequisite for condign enlightened of variation in processes and implementing measures to eliminate it. Therefore, we propose that finalizing an inspection based on documented changes in structure and process elements addressed in the nonconformity statement is more likely to contribute to improved quality of care than solely finalizing the inspection based on documented changes in the structure deficiencies addressed in the nonconformity statement.

Each pattern we identified was associated with primary care and specialized intendance, which might signal that organizational characteristics are involved in understanding the emergence of these two patterns. Primary intendance and specialized care stand for two different types of organizations in Norway. Hospitals are owned and operated past regional wellness trusts, which provide a common superstructure. Primary care is provided past municipalities, which are single entities without any formal superstructure. This departure in organizational characteristics can accept consequences for the inspecting organisation's power to follow up inspections. The canton governors used the same type of diction to depict the kind of general documentation they requested from both types of organizations following their inspection. However, our findings do not provide insight into the county governors' actual level of expectations from these 2 types of organizations. The standards used for inspections in primary care and specialized intendance are not the same, which leads to unlike expectations. Our findings practise non provide information almost how the Norwegian Board of Wellness Supervision operationalized the requirements prior to the inspections. The way the requirements are operationalized can impact how the county governors acquit and follow up their inspections and contribute to shape their expectations. Based on their longstanding duty of conducting inspections, the county governors possess contextual cognition about all of the wellness-care organizations in their region. This knowledge might non be reflected in the written material, but can however contribute to shape their expectations and influence how different organizations are existence followed up. We suggest that the ii patterns are caused by a complex set of contextual factors related to the inspected organizations themselves, the way the inspections are prepared, and the actions of the inspecting organization during the detection and enforcement phase.

Limitations and further research

Our findings are based on an explorative review of cases with a limited number of inspections conducted in i country, and should therefore be interpreted with circumspection. An observational and retrospective study design like ours has limitations of information bias and confounding, and we cannot say whether the patterns we identified are associated with improved clinical processes and outcomes. Written documents were our only source of data. In these documents, nosotros plant references to other sources of communication between the county governors and the inspected organizations, e.thousand. telephone calls and meetings. The county governors' actions and decisions when post-obit up nonconformities were most likely as well based on information not credible in the written documents. Despite this shortcoming, we assert that the main ways of advice during the enforcement phase was based on written documents, and the determination to finalize the inspection was always conveyed to the inspected organization by means of a written document.

We used purposive sampling to deport our explorative review, and included inspections of primary care and specialized care organizations past all of the county governors in Norway. Furthermore, nosotros included a range of dissimilar inspection themes and identified two distinct patterns for how nonconformity statements were supported and enforced. No other themes emerged during the assay. The frequency counts in Table 1 prove numerous cases for each of the patterns that nosotros identified. Therefore, we affirm that our data fabric was sufficiently diverse and rich plenty for data saturation [21, 35].

The findings from this exploratory study need to be validated in larger studies. Such research could benefit from a prospective design and past using mixed methods. Future studies should investigate what relevance the patterns we identified for supporting and following up nonconformities have for the inspected system's ability to improve their quality of care.

Conclusion

Nosotros identified two patterns for how observations supported the nonconformity statement: one in which information technology was clearly demonstrated how deficiencies in the direction organisation could affect clinical processes, and one in which this connectedness was non demonstrated. We identified 2 patterns characterizing how the inspecting organization followed upwardly the inspected arrangement and finalized the inspection: one in which the inspection was finalized based solely on documented changes in structural elements addressed in the nonconformity argument, and one based on documented changes in both the structural and process deficiencies addressed in the nonconformity argument. A core purpose of an inspection is that information technology should contribute to comeback of the quality of care. We suggest that nonconformity statements should exist grounded past observations that clearly demonstrate how deficiencies in the direction system might affect the clinical processes. Furthermore, inspections should be finalized based on documented changes in both the structural and procedure deficiencies addressed in the nonconformity statement.

References

1. Tuijn SM, Robben PB, Janssens FJ, van den Bergh H. Evaluating instruments for regulation of health intendance in the Netherlands. J Eval Clin Pract. 2011;17(three):411–9.

   Commodity  PubMed  Google Scholar

2. Shaw CD, Braithwaite J, Moldovan Thousand, Nicklin W, Grgic I, Fortune T, et al. Profiling health-intendance accreditation organizations: an international survey. Int J Qual Wellness Care. 2013;25(3):222–31.

   Article  PubMed  Google Scholar

3. Shaw C. The external cess of wellness services. World Hosp Health Serv. 2004;40(1):24–7. 50, 51.

   PubMed  Google Scholar

4. Walshe One thousand, Wallace L, Freeman T, Latham L, Spurgeon P. The external review of quality improvement in health care organizations: a qualitative study. Int J Qual Health Intendance. 2001;13(five):367–74.

   CAS  Article  PubMed  Google Scholar

5. Shaw CD. External quality mechanisms for wellness care: summary of the ExPeRT project on visitatie, accreditation, EFQM and ISO assessment in European Union countries. Int J Qual Health Intendance. 2000;12(3):169–75.

   CAS  Article  PubMed  Google Scholar

6. Flodgren G, Pomey 1000-P, Taber Sarah A, Eccles MP. Effectiveness of external inspection of compliance with standards in improving healthcare organisation behaviour, healthcare professional person behaviour or patient outcomes. Cochrane Database Syst Rev. 2011;eleven, CD008992.

   PubMed  Google Scholar

7. Walshe Thousand, Freeman T, Latham L, Wallace L, Spurgeon P. Clinical governance - from policy to exercise. Birmingham, United kingdom of great britain and northern ireland: University of Birmingham, Health Services Management Middle; 2000. Chapter six. The development of external reviews of clinical governance.

   Google Scholar

8. Walshe M, Boyd A. Designing regulation: a review. Manchester: The University of Manchester - Manchester Business School; 2007.

   Google Scholar

9. Sutherland K, Leatherman South. Regulation and quality improvement - A review of the evidence. London: The Health Foundation; 2006.

   Google Scholar

10. Johnston Grand, Crombie IK, Davies HT, Alder EM, Millard A. Reviewing audit: barriers and facilitating factors for effective clinical inspect. Qual Health Care. 2000;nine(1):23–36.

    CAS  Article  PubMed  PubMed Key  Google Scholar

11. Benson LA, Boyd A, Walshe Chiliad. Learning from regulatory interventions in healthcare: The Commission for Health Improvement and its clinical governance review procedure. Clin Governance: An Int J. 2006;11(3):213–24.

    Article  Google Scholar

12. Hinchcliff R, Greenfield D, Moldovan M, Westbrook JI, Pawsey Thousand, Mumford V, et al. Narrative synthesis of health service accreditation literature. BMJ Qual Safety. 2012;21(12):979–91.

    Article  Google Scholar

13. Greenfield D, Braithwaite J. Wellness sector accreditation research: a systematic review. Int J Qual Wellness Care. 2008;20(three):172–83.

    Article  PubMed  Google Scholar

14. Ngo D, Breejen E, Putters K, Bal R. Supervising the quality of care in irresolute healthcare systems - An international comparison. Rotterdam: Erasmus University Dept. of Healthcare Governance Institute of Health Policy and Management; 2008.

    Google Scholar

15. Sparreboom WF. How effective are you lot? A research on how health care regulators beyond Europe written report the effectiveness of regulation. Master's thesis. Utrecht: VU University Amsterdam; 2009.

    Google Scholar

16. Berwick DM. Crossing the boundary: changing mental models in the service of improvement. Int J Qual Health Care. 1998;10(5):435–41.

    CAS  Article  PubMed  Google Scholar

17. Plsek PE, Greenhalgh T. Complexity scientific discipline - The claiming of complexity in health care. Br Med J. 2001;323(7313):625–8.

    CAS  Article  Google Scholar

18. Institute of Medicine Committee on Quality of Wellness Care in America. Crossing the quality chasm: a new health organization for the 21st century. Washington DC: Plant of Medicine; 2001.

    Google Scholar

19. Hood C. Regulation inside government: waste watchers, quality police force, and sleaze-busters. Oxford: Oxford Academy Press; 1999.

    Book  Google Scholar

20. ISO: ISO/IEC TS 17022:2012. Conformity assessment. Requirements and recommendations for content of a tertiary-party audit report on management systems. Geneva: International Organization for Standardization; 2012.

    Google Scholar

21. Patton MQ. Qualitative research & evaluation methods. London: Sage Publications; 2002.

    Google Scholar

22. Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005;15(9):1277–88.

    Article  PubMed  Google Scholar

23. Donabedian A. The quality of intendance. How can it exist assessed? JAMA. 1988;260(12):1743–8.

    CAS  Commodity  PubMed  Google Scholar

24. Creswell JW. Qualitative inquiry & enquiry pattern: choosing among v approaches. Grand Oaks, CA: Sage Publications; 2007.

    Google Scholar

25. Askim J. Hvordan påvirker det statlige tilsynet kommunene og det lokale selvstyret? 2013;20. Oslo: NIBR; 2013.

    Google Scholar

26. The Norwegian Board of Health Supervision. Vi får satt fokus, blir bevisstgjort og må skjerpe faget… - En deskriptiv undersøkelse med kommunale helse- og omsorgstjenester til eldre. Oslo: Statens Helsetilsyn; 2013. p. half dozen.

    Google Scholar

27. Robblee JA, Heidemann EG. Hospital accreditation and the surgeon: the Canadian feel. Surgeon. 2004;2(6):321–6.

    CAS  Commodity  PubMed  Google Scholar

28. Power M. The audit society — second thoughts. Int J Auditing. 2000;4(1):111–ix.

    Article  Google Scholar

29. Grol R, Wensing K. What drives alter? Barriers to and incentives for achieving evidence-based practice. Med J Aust. 2004;180(6 Suppl):S57–lx.

    PubMed  Google Scholar

30. Hilarion P, Sunol R, Groene O, Vallejo P, Herrera East, Saura RM. Making performance indicators work: the experience of using consensus indicators for external assessment of health and social services at regional level in Spain. Wellness Policy. 2009;90(ane):94–103.

    Commodity  PubMed  Google Scholar

31. Grol R, Grimshaw J. From best evidence to best do: effective implementation of modify in patients' care. Lancet. 2003;362(9391):1225–30.

    Commodity  PubMed  Google Scholar

32. Grimshaw JM, Thomas RE, MacLennan Yard, Fraser C, Ramsay CR, Vale 50, et al. Effectiveness and efficiency of guideline broadcasting and implementation strategies. Health Technol Appraise. 2004;8(6):iii–iv. 1–72.

    CAS  Commodity  PubMed  Google Scholar

33. Groene O, Sunol R. DUQuE Project Consortium. The investigators reflect: what nosotros have learned from the Deepening our Understanding of Quality Improvement in Europe (DUQuE) written report. Int J Qual Health Intendance. 2014;26 suppl one:2–4.

    Commodity  PubMed  PubMed Central  Google Scholar

34. Langley GJ. The Improvement guide: a practical approach to enhancing organizational performance. San Francisco, CA: Jossey-Bass; 2009.

    Google Scholar

35. Lincoln YS, Guba EG. Naturalistic inquiry. Beverly Hills, CA: Sage; 1985.

    Google Scholar

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Acknowledgments

We thank all the county governor offices in Norway for providing information.

Author information

Affiliations

1. Institute of Social Scientific discipline, Sogn og Fjordane University College, PO Box 133, 6851, Sogndal, Norway

   Einar Hovlid

2. The Norwegian Board of Health Supervision, PO Box 8128 Dep, 0032, Oslo, Norway

   Einar Hovlid, Helge Høifødt, Bente Smedbråten & Geir Sverre Braut

3. Stavanger Academy Hospital, PO Box 8100, 4068, Stavanger, Norway

   Geir Sverre Braut

Corresponding author

Correspondence to Einar Hovlid.

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Competing interests

The authors declare that they have no competing interests.

Authors' contributions

EH had total access to all the data in the study and takes responsibleness for the integrity of the data and accuracy of the data assay. EH, HH, BS, and GSB conceived and designed the study. HH nerveless the data. EH, HH, and GSB analyzed and interpreted the data. EH and GSB drafted the manuscript. EH, HH, BS, and GSB critically revised the manuscript for of import intellectual content. All authors read and approved the final manuscript.

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Hovlid, Eastward., Høifødt, H., Smedbråten, B. et al. A retrospective review of how nonconformities are expressed and finalized in external inspections of health-care facilities. BMC Health Serv Res 15, 405 (2015). https://doi.org/10.1186/s12913-015-1068-9

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• Received: 21 February 2015

• Accepted: 14 September 2015

• Published: 23 September 2015

• DOI : https://doi.org/10.1186/s12913-015-1068-ix

Keywords

• External inspection
• Quality improvement
• Nonconformity
• Management system
• Clinical governance

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