The story of change
The following story is presented in two stages. The first outlines the initial establishment of the external project that initiated the pilot process in the ED. The second narrates the intra-organizational sensemaking that contributed to continuity and change in favor of ISO 9001 certification.
Following up on unacceptable conditions in emergency departments
In 2007 the Norwegian Board of Health Supervision (NBHS) carried out a countrywide supervision of 27 out of 54 hospital emergency departments in Norway, and concluded that in general, there was a lack of management responsibility for ensuring that daily tasks were planned, organized, carried out, and improved in accordance with legislative requirements [51]. The NBHS described the situation as unacceptable and required the management to take action.
As a direct follow-up of this report the Norwegian Accreditation (NA)Footnote 2 and one Regional Health Authority (RHA) initiated a collaborative project. Its objective was to set a standard that EDs could use to ensure and improve internal control and management systems, and for accreditation or certification purposes [52]. A sector committeeFootnote 3 including an administrative project organization, the regional project group (RPG), was established in the spring of 2008.
The sector committee was composed of representatives from all the RHA, NBHS, and other professional experts, and their work took place from August 2008 until March 2010. The new accreditation standard for EDs was supposed to concretize the generic requirements in the legal internal control regulation. The committee considered different management standards to build upon or implement, and decided on the ISO 9001:2008 Quality Management System - requirements standard, with its additional guidelines for use in health services [23]. The main reason was that the ISO 9001 was in compliance with the current Norwegian internal control regulation. Two ED was chosen as pilots for the project, in order to (1) identify core processes and risk areas to specify new requirements for EDs and (2) become ISO 9001 certified and meet the new requirements. One of the EDs ended the process before becoming certified, and the other, whose story is told in the next section, became certified in 2010 [53].
The initial phase
The ED had struggled for years with a heavy and challenging patient flow, and worked to improve the system without acceptable results [frame]. During this time there had been a change towards more attention to quality improvement and control, both through central, regional, and local initiatives. The RHA had become more explicit on requirements about, among others, waiting time for patients, patient safety, and prevention of infections [frame]. The ED was also in the middle of a rebuilding and merging process to take over the emergency functions from another hospital. The volume of patients was high, they were kept waiting, and there was not enough beds [concern].
The ED got two nonconformities from the countrywide supervision that required managerial follow-up. The first nonconformity pertained to the accumulation of patients that could lead to failure of treatment; the second was related to the examination conditions in the ED, which did not ensure adequate protection of confidentiality, patient integrity, and information exchange [cue]. The challenges in the ED were once again highlighted [cue] and the hospital top management became more involved in resolving these challenges [discrepancy]. The ED once again started to look for solutions and make efforts to improve patient flow [action].
Some months after the report from the NBHS, the hospital trusts in the RHA were asked to participate in the pilot project. The ED was then asked by their hospital CEO [cue]. The Head of Department had a quick consultation with middle managers in the ED, and the response was “Yes, let us jump on it” (Informant Y). They immediately decided to participate in the pilot [action]. Their expectation was to get the assistance to work systematically to resolve the challenges in the ED [concern].
The process in the ED started in autumn 2008. The first meeting was represented by people from the hospital who delivered services to the ED (e.g., physicians and the X-ray department) in addition to people from the regional project group. The intention was to anchor the project with concern to those departments that delivered services to the ED, and not just the ED in isolation [concern]. Especially, the integration of physicians was considered important [concern]. The head of department was the hospitals representative in the RPG and was highly involved in the development of the new requirement for EDs during spring 2009. She also became a key actor and a primer for the local pilot throughout the project.
During spring 2009, the ED established a local project group (LPG) led by the head of department and three middle managers [action]. At that time they did not know what to expect, other than they would be assessing and describing processes, identification of system vulnerabilities, and implementation of relevant actions in the ED [discrepancy]. In any case, they immediately threw themselves into the work, starting to describe processes and identify vulnerabilities [action]. After a while they were made aware of [cue] that the pilot project would involve the use of the ISO 9001 standard [discrepancy]. Then they realized their need for local assistance about developing quality management systems [concern]. A quality adviser from the Quality and Research Department integrated in the LPG [action]. The main work on ISO 9001 certification began in the summer of 2009.
The standardization and certification phase: summer–autumn 2009
The LPG worked enthusiastically and intensively, especially in July and August 2009. Most of the group members worked extra to complete the work [action]. The rest of the employees in the ED were less involved, limiting their participation to some ad hoc working groups, such as those to establish and revise procedures. Even though the LPG had agreed that the main intention for the ED was to review their management systems [frame], there seemed to be a clear awareness among the LPG members that the hard work on standardization consisted of taking steps towards certification [concern]. They had an opportunity for external help with improvement work, and this extra focus [cue] seemed to generate actions and a desire to demonstrate that they now were able to succeed [concern].
[I]t was a combination of several things. […] When the crisis is big, it’s even more important to get things done. It’s a motivation in itself to do something—that was important. We were selected from the Regional Health Authority to accomplish this—that was an important element. […] It turned out just like a competitive element, just like: ‘This is something we can master’. Clearly, much was done before the certification body came in. We had been working very much; however, they did the last part in order to push us all the way to the end. (Informant Z)
None of the LPG members had experiences [frame] with ISO 9001 standardization and certification processes [discrepancy], except for one member of the quality department, who became an important “translator” [cue] of the ISO standard during the pilot project. The standard needed contextual adaptations to be legitimated in the ED [concern]. Terms like risk assessments, measuring, monitoring, and recording are obvious concepts and parts of an ISO quality management systems, but it was an unfamiliar terminology for the LPG [discrepancy]. The additional ED requirements developed during the project became important concretizations of the ISO 9001 standard and the internal control regulations. It generated a contextual translation [cue] of rather general requirements [discrepancy] and so ordinated a meaningful operationalization in the ED [action]. As “newcomers” [frame], the LPG needed concretization [concern].
The LPG referred favorably to the certification body. In the first phase of preparing the ED for the initial onsite document review, there was a large amount of e-mail between the ED and the certification body. The hospital received much advice and help on how to improve the organization [cue]. The auditors were considered very detailed, sometimes almost too much [discrepancy], especially during document reviews and the certification audit. At the same time the auditors created confidence with their detailed knowledge and ability to identify salient points and ask questions about the documents and systems [cue]. They also transferred experiences from other organizations and brought expert knowledge on systems and change processes. The LPG experienced the certification process more as guidance than as control [discrepancy].
It was a turning point for the LPG when they received feedback from the certification body and gained experience from the standardization process itself [cue] that changed their understanding of systems that they had considered well-functioning: “things that we took for granted” (Informant Y), but were not good enough [discrepancy]. They started working differently with their systems [action] which generated an improved overview of their organization and tasks [cue], the number of procedures was reduced considerably [cue], and explicit objectives for improvement was created [cue]. The latter was a shift from describing objectives in general concerns, like “we should be better at…” to develop measurable objectives that could be monitored. The entire improvement and certification process [action] was considered as an important help [frame].
The initial countrywide supervision pinpointed the responsibility of other professions, especially physicians, to hold them accountable for the challenges in the ED [cue]. The emphasis on creating descriptions and visualization of core processes in the ED [action] made the department more visible and the process was considered a key to the shared understanding and commitment among leaders in other departments [cue]. The certification body drove this accountability concern further, and mutual contracts with “service” departments (including physicians) was a requirement for certification [cue]. “A milestone could be seen when agreements with other heads of departments became evident” (Informant X).
There were some worries among the employees in the ED about the perceived absence of management [cue], but the LPG did not enact any significant opposition either inside or outside the ED [cue]. The fact that the ED was a part of the pilot project and was supposed to [frame] organize for and deliver a service that was certifiable [discrepancy] was regarded as an important driver, not just for the LPG but also for other professions outside the ED that participated in working groups. It seemed that “no one” would contribute to the failure of a certification status, especially since it was decided at the top of the organization and as a direct follow-up of the external supervision [concern].
[T]he symbolic perspective of certification is just as prominent as the rational. I believe that, and that’s my conclusion. Much of the things that we initiate are like that. Symbolic perspectives should not be underestimated (Informant Z).
After following up on the nonconformities that were given during the certification audit, the ED finally received its first ISO 9001 certificate in January 2010.
The time after: winter 2010–summer 2012
According to the managers and the LPG, the ISO certification process generated improvement of the management system; however, a direct impact on patient treatment was hard to demonstrate [frame]. ISO 9001 was considered as a managerial tool [frame]. When the revised management system was contrasted with the situation before certification, it illustrated both positive practical implications and improved daily organizing of the ED [frame]. The ED management started talking differently about quality improvement, and used terms and explanations that had originated from the standardization and certification process [action]. They were proud of their achievement and gladly shared their material and experiences. The ISO standard and the additional requirements for EDs were not considered the optimum way of organizing, but it was treated as one way, among many others, that generated system improvement [frame]:
[T]he fact that we are ISO-certified—as I say: We have put some things in place; it is easier to find, easier to breathe, you don’t need to doubt, you don’t have to look; it is helping to create those secure frames. So that those who work within these frames are given the opportunity to flourish in the face of the patient. (Informant W)
Even though the LPG considered the certification process to imply system improvement [frame], they did not expect that the employees would perceive quality improvements, or associate system changes with the ISO certification [concern], since the certification process did not really affect the daily operations and patient treatment. At least two other quality improvement initiatives (triage and nurses’ continuing education) were initiated in parallel with the certification process, and these were considered to have more positive association with improved treatment quality compared to the ISO certification [cue].
The ED underwent two yearly surveillance auditsFootnote 4 conducted by the certification body after the initial certification audit. These external assessments were considered important for sustainability of quality improvement [cue], even though the management understood that quality improvement should be part of everyday practice [discrepancy]. Whether these audits needed to be performed by a third-party certification body was not considered of major importance, and neither was the importance of the certificate in itself [Frame].
The ED management started to question the need for further use of an external certification body [concern]. These concerns were based on (1) negative experiences from the latest surveillance audit, where a new team from the certification body conducted the audit [discrepancy], (2) the costs and resources spent [frame], and (3) having brought their quality management system to an acceptable level. The ED management had generated knowledge that enabled the ED to perform ongoing system improvements on its own [frame]. However, some sort of external audit was considered necessary [concern]. Internal audits performed by the quality department in the hospital was in theory considered equal with external audits, but in practice the external audits (e.g., by a certification body, NBHS, or the RHA) had stronger impact and triggered more managerial action than internal audits [discrepancy]. Managers from the LPG changed their perspective on audits, from seeing them as a way of controlling organizations to something useful for sustainable improvement [frame]. They started asking for internal audits and acknowledged the possibility of letting someone outside the department assess their systems and give feedback [action]. Nonconformities were used as means for further improvement [frame].
[F]or the last couple of years we have requested audits, when there are things we are questioning. […] It’s not so frightening anymore, and we see that it’s very useful for us. That I think is a result of the process. We are not so afraid of getting nonconformities, and see that these [nonconformities] are things that we can work on. (Informant V)