Healthcare leaders' and elected politicians' approach to support-systems and requirements for complying with quality and safety regulation in nursing homes - a case study.

BACKGROUND: Healthcare leaders play an important and complex role in managing and handling the dual responsibility of both Health, Safety and Environment (HSE) for workers and quality and patient safety (QPS). There is a need for better understanding of how healthcare leaders and decision makers organize and create support structures to handle these combined responsibilities in practice. The aim of this study was to explore how healthcare leaders and elected politicians organize, control, and follow up the work of HSE and QPS in a Norwegian nursing home context. Moreover, we explore how they interpret, negotiate, and manage the dual responsibility and possible tensions between employee health and safety, and patient safety and quality of service delivery. METHODS: The study was conducted in 2022 as a case study exploring the experience of healthcare leaders and elected politicians in five municipalities responsible for providing nursing homes services in Norway. Elected politicians (18) and healthcare leaders (11) participated in focus group interviews (5) and individual interviews (11). Data were analyzed using inductive thematic analysis. RESULTS: The analysis identified five main themes explaining how the healthcare leaders and elected politicians organize, control, and follow up the work of HSE and QPS: 1. Establish frameworks and room for maneuver in the work with HSE and QPS. 2. Create good routines and channels for communication and collaboration. 3. Build a culture for a health-promoting work environment and patient safety. 4. Create systems to handle the possible tensions in the dual responsibility between caring for employees and quality and safety in service delivery. 5. Define clear boundaries in responsibility between politics and administration. CONCLUSIONS: The study showed that healthcare leaders and elected politicians who are responsible for ensuring sound systems for quality and safety for both patients and staff, do experience tensions in handling this dual responsibility. They acknowledge the need to create systems and awareness for the responsibility and argue that there is a need to better separate the roles and boundaries between elected politicians and the healthcare administration in the execution of HSE and QPS.

Complex challenges should be approached by a multitude of theories and models.

The ongoing pandemic may be regarded as a wicked problem. Therefore, it should be analyzed by a multitude of theories and models. Approaching the complex set of challenges posed to individuals and society by singular methods, can lead to suboptimal decisions. Good decisions must take into account the large set of uncertainties we are facing, by using well established procedures, as for example health technology assessment (HTA) and a nuanced ethical framework.

The effect of Zhang's guideline vs the WHO partograph on childbirth experience measured by the Childbirth Experience Questionnaire in the Labor Progression Study (LaPS): A cluster randomized trial.

INTRODUCTION: Childbirth experience is an increasingly recognized and important measure of quality of obstetric care. Previous research has shown that it can be affected by intrapartum care and how labor is followed. A partograph is recommended to follow labor progression by recording cervical dilation over time. There are currently different guidelines in use worldwide to follow labor progression. The two main ones are the partograph recommended by the World Health Organization (WHO) based on the work of Friedman and Philpott and a guideline based on Zhang's research. In our study we assessed the effect of adhering to Zhang's guideline or the WHO partograph on childbirth experience. Zhang's guideline describes expected normal labor progression based on data from contemporary obstetric populations, resulting in an exponential progression curve, compared with the linear WHO partograph. The choice of labor curve affects the intrapartum follow-up of women and this could potentially affect childbirth experience. MATERIAL AND METHODS: The Labor Progression Study (LaPS) study was a prospective, cluster randomized controlled trial conducted at 14 birth centers in Norway. Birth centers were randomized to either follow Zhang's guideline or the WHO partograph. Nulliparous women in active labor, with one fetus in cephalic presentation at term and spontaneous labor onset were included. At 4 weeks postpartum, included women received an online login to complete the Childbirth Experience Questionnaire (CEQ). Total score on the CEQ, the four domain scores on the CEQ, and scores on the individual items on the CEQ were compared between the two groups. RESULTS: There were 1855 women in the Zhang group and 1749 women in the WHO partograph group. There was no difference in the total or domain CEQ scores between the two groups. We found statistically significant differences for two individual items; women in the Zhang group scored lower on positive memories and feeling of control. CONCLUSIONS: Based on our findings on childbirth experience there is no reason to prefer Zhang's guideline over the WHO partograph.

Forensic autopsies in Norway 1996-2017: A retrospective study of factors associated with deaths undergoing forensic autopsy.

AIMS: Forensic autopsies are important for the investigation of deaths with a legal or public-health interest, as well as being a source for cause-of-death statistics. The aim of this study was to investigate the use of forensic autopsies in Norway, with a special emphasis on geographical variation. METHODS: Data from the Norwegian Cause of Death Registry for the years 1996-2017 included 920,232 deaths and 37,398 forensic autopsies. We used logistic regression to identify factors that were associated with the proportion of forensic autopsies, grouped according to the registered cause of death. Explanatory variables were age and sex, place of death, police district, population size and urbanity level of the municipality and distance to the autopsy facility. RESULTS: The proportion of deaths undergoing forensic autopsy was 4.1%, with the highest being homicides (96.6%) and the lowest being deaths from natural causes (1.7%). Variation between police districts was 0.9-7.8%, and the span persisted during the study period. The most important explanatory variables across the strata were place of death (there were few autopsies of deaths in health-care facilities), police district and age of the deceased. Distance to the autopsy facility, sex, population size and the level of urbanity had only a minor influence. The variation between police districts was not fully accounted for by the other investigated factors. CONCLUSIONS: Unjustified differences in the frequency of autopsies may lead to insufficient investigation of possible unnatural deaths. In worst-case scenarios, homicides or other criminal cases might remain undetected. It may also introduce spurious shifts in the cause-of-death statistics.

Estimating the consequences of a COVID-19 super spreader: A stochastic model of a night on the town.

A stochastic model estimated the consequences of a COVID-19 super spreader event occurring in the local municipality of Stavanger, Norway as a result of a night on the town. The model imposed different infection control regulations and compared these different scenarios. For Stavanger's 161 locations of service, secondary transmissions from a super spreader event was estimated to infect a median of 37, requiring the quarantining of 200 guests given no infection control regulations, 23 and 167 when imposing social distancing regulations and other hygienic infection control measures, 7 infected and 63 quarantined guests with restrictions placed on the guest capacity, and 4 infected and 57 quarantined guests with both forms of restriction in use.

Garbage codes in the Norwegian Cause of Death Registry 1996-2019.

BACKGROUND: Reliable statistics on the underlying cause of death are essential for monitoring the health in a population. When there is insufficient information to identify the true underlying cause of death, the death will be classified using less informative codes, garbage codes. If many deaths are assigned a garbage code, the information value of the cause-of-death statistics is reduced. The aim of this study was to analyse the use of garbage codes in the Norwegian Cause of Death Registry (NCoDR). METHODS: Data from NCoDR on all deaths among Norwegian residents in the years 1996-2019 were used to describe the occurrence of garbage codes. We used logistic regression analyses to identify determinants for the use of garbage codes. Possible explanatory factors were year of death, sex, age of death, place of death and whether an autopsy was performed. RESULTS: A total of 29.0% (290,469/1,000,128) of the deaths were coded with a garbage code; 14.1% (140,804/1,000,128) with a major and 15.0% (149,665/1,000,128) with a minor garbage code. The five most common major garbage codes overall were ICD-10 codes I50 (heart failure), R96 (sudden death), R54 (senility), X59 (exposure to unspecified factor), and A41 (other sepsis). The most prevalent minor garbage codes were I64 (unspecified stroke), J18 (unspecified pneumonia), C80 (malignant neoplasm with unknown primary site), E14 (unspecified diabetes mellitus), and I69 (sequelae of cerebrovascular disease). The most important determinants for the use of garbage codes were the age of the deceased (OR 17.4 for age ≥ 90 vs age < 1) and death outside hospital (OR 2.08 for unknown place of death vs hospital). CONCLUSION: Over a 24-year period, garbage codes were used in 29.0% of all deaths. The most important determinants of a death to be assigned a garbage code were advanced age and place of death outside hospital. Knowledge of the national epidemiological situation, as well as the rules and guidelines for mortality coding, is essential for understanding the prevalence and distribution of garbage codes, in order to rely on vital statistics.

Global surgery, obstetric, and anaesthesia indicator definitions and reporting: An Utstein consensus report.

BACKGROUND: Indicators to evaluate progress towards timely access to safe surgical, anaesthesia, and obstetric (SAO) care were proposed in 2015 by the Lancet Commission on Global Surgery. These aimed to capture access to surgery, surgical workforce, surgical volume, perioperative mortality rate, and catastrophic and impoverishing financial consequences of surgery. Despite being rapidly taken up by practitioners, data points from which to derive the indicators were not defined, limiting comparability across time or settings. We convened global experts to evaluate and explicitly define-for the first time-the indicators to improve comparability and support achievement of 2030 goals to improve access to safe affordable surgical and anaesthesia care globally. METHODS AND FINDINGS: The Utstein process for developing and reporting guidelines through a consensus building process was followed. In-person discussions at a 2-day meeting were followed by an iterative process conducted by email and virtual group meetings until consensus was reached. The meeting was held between June 16 to 18, 2019; discussions continued until August 2020. Participants consisted of experts in surgery, anaesthesia, and obstetric care, data science, and health indicators from high-, middle-, and low-income countries. Considering each of the 6 indicators in turn, we refined overarching descriptions and agreed upon data points needed for construction of each indicator at current time (basic data points), and as each evolves over 2 to 5 (intermediate) and >5 year (full) time frames. We removed one of the original 6 indicators (one of 2 financial risk protection indicators was eliminated) and refined descriptions and defined data points required to construct the 5 remaining indicators: geospatial access, workforce, surgical volume, perioperative mortality, and catastrophic expenditure. A strength of the process was the number of people from global institutes and multilateral agencies involved in the collection and reporting of global health metrics; a limitation was the limited number of participants from low- or middle-income countries-who only made up 21% of the total attendees. CONCLUSIONS: To track global progress towards timely access to quality SAO care, these indicators-at the basic level-should be implemented universally as soon as possible. Intermediate and full indicator sets should be achieved by all countries over time. Meanwhile, these evolutions can assist in the short term in developing national surgical plans and collecting more detailed data for research studies.

How common is substandard obstetric care in adverse events of birth asphyxia, shoulder dystocia and postpartum hemorrhage? Findings from an external inspection of Norwegian maternity units.

INTRODUCTION: The Norwegian Board of Health Supervision inspects healthcare institutions to ensure safety and quality of health and welfare services. A planned inspection of 12 maternity units aimed to investigate the practice of obstetric care in the case of birth asphyxia, shoulder dystocia and severe postpartum hemorrhage. MATERIAL AND METHODS: The inspection was carried out at two large, four medium and six small maternity units in Norway in 2016 to investigate adverse events that occurred between 1 January and 31 December 2014. Six of them were selected as control units. The Norwegian Board of Health Supervision searched the Medical Birth Registry of Norway to identify adverse events in each of the categories and then requested access to the medical records for all patients identified. Information about guidelines, formal teaching and simulation training at each unit was obtained by sending a questionnaire to the obstetrician in charge of each maternity unit. RESULTS: The obstetric units inspected had 553 serious adverse events of birth asphyxia, shoulder dystocia or severe postpartum hemorrhage among 17 323 deliveries. Twenty-nine events were excluded from further analysis due to erroneous coding or missing data in the patients' medical records. We included 524 cases (3.0% of all deliveries) of adverse events in the final analysis. Medical errors caused by substandard care were present in 295 (56.2%) cases. There was no difference in the prevalence of substandard care among the maternity units according to their size. Surprisingly, we found significantly fewer cases with substandard care in the units which the supervisory authorities considered particularly risky before the inspection, compared with the control units. Seven of the 12 units had regular formal teaching and training arrangements for obstetric healthcare personnel as outlined in the national guidelines. CONCLUSIONS: Prevalence of adverse events was 3% and similar in all maternity units irrespective of their size. A breach in the standard of care was observed in 56.2% of cases and almost half of the maternity units did not follow national recommendations regarding teaching and practical training of obstetric personnel, suggesting that they should focus on implementing guidelines and training their staff.

COVID-19: systematic learning across boundaries requires a conceptual agreement.

The COVID-19 epidemic has revealed a shortage of basic knowledge and understanding of pandemics, especially regarding their dynamics and how to contain them. The results are a host of governments' decrees and instructions, one replacing the other, often within the same week. It has further, in a truly short time, resulted in an overwhelming number of publications, many of them prioritising early publication over quality. This commentary addresses the concept of structured research related to disasters and how the use of endorsed guidelines will facilitate well-designed evaluation research with improved rigour and external validity, even if applied retrospectively. The outcome should be a solidified knowledge base. Further, the important role of public health efforts is to be highlighted, as their role has proved crucial during the COVID-19 pandemic.

Adverse events reporting by obstetric units in Norway as part of their quality assurance and patient safety work: an analysis of practice.

BACKGROUND: The Norwegian Board of Health Supervision aims to contribute to the improvement of quality and patient safety in the healthcare services. Planned audits were performed to investigate how 12 selected Norwegian obstetric units reported and analyzed adverse events as the part of their quality assurance and patient safety work. METHODS: Serious adverse events coded as birth asphyxia, shoulder dystocia and severe postpartum hemorrhage that occurred during 2014 (the most recent year for which the quality assured data were available) were obtained from the Medical Birth Registry of Norway. The obstetric units were asked to submit medical records, internal adverse events reports, and their internal guidelines outlining which events should be reported to the quality assurance system. We identified the adverse events at each obstetric unit that were reported internally and/or to the central authorities. Two obstetricians carried out an evaluation of each event reported. RESULTS: Five hundred fifty-three serious adverse events were registered among 17,323 births that took place at the selected units. Twenty-one events were excluded because of incorrect coding or missing information. Eight events were registered in more than one category, and these were distributed to the category directly related to injury or adverse outcome. Nine of twelve (75 %) obstetric units had written guidelines describing which events should be reported. The obstetric units reported 49 of 524 (9.3 %) serious adverse events in their internal quality assurance system and 39 (7.4 %) to central authorities. Of the very serious adverse events, 29 of 149 (19.4 %) were reported. Twenty-three of 49 (47 %) reports did not contain relevant assessments or proposals for improving quality and patient safety. CONCLUSIONS: This study showed that adverse event reporting and analyses by Norwegian obstetric units, as a part of quality assurance and patient safety work, are suboptimal. The reporting culture and compliance with guidelines need to be improved substantially for better safety in patient care, risk mitigation and clinical quality assurance.

Exploring links between resilience and the macro-level development of healthcare regulation- a Norwegian case study.

BACKGROUND: The relationship between quality and safety regulation and resilience in healthcare has received little systematic scrutiny. Accordingly, this study examines the introduction of a new regulatory framework (the Quality Improvement Regulation) in Norway that aimed to focus on developing the capacity of hospitals to continually improve quality and safety. The overall aim of the study was to explore the governmental rationale and expectations in relation to the Quality Improvement Regulation, and how it could potentially influence the management of resilience in hospitals. The study applies resilience in healthcare and risk regulation as theoretical perspectives. METHODS: The design is a single embedded case study, investigating the Norwegian regulatory healthcare regime. Data was collected by approaching three regulatory bodies through formal letters, asking them to provide internal and public documents, and by searching through open Internet-sources. Based on this, we conducted a document analysis, supplemented by interviews with seven strategic informants in the regulatory bodies. RESULTS: The rationale for introducing the Quality Improvement Regulation focused on challenges associated with implementation, lack of management competencies; need to promote quality improvement as a managerial responsibility. Some informants worried that the generic regulatory design made it less helpful for managers and clinicians, others claimed a non-detailed regulation was key to make it fit all hospital-contexts. The Government expected hospital managers to obtain an overview of risks and to adapt risk management and quality improvement measures to their specific context and activities. CONCLUSIONS: Based on the rationale of making the Quality Improvement Regulation flexible to hospital context, encouraging the ability to anticipate local risks, along with expectations about the generic design as challenging for managers and clinicians, we found that the regulators did consider work as done as important when designing the Quality Improvement Regulation. These perspectives are in line with ideas of resilience. However, the Quality Improvement Regulation might be open for adaptation by the regulatees, but this may not necessarily mean that it promotes or encourages adaptive behavior in actual practice. Limited involvement of clinicians in the regulatory development process and a lack of reflexive spaces might hamper quality improvement efforts.

Overcommitment: Management in Helicopter Emergency Medical Services in Norway.

OBJECTIVE: Overcommitment in demanding rescue situations may put both rescuers and patients in danger. This study aimed at identifying individual approaches and organizational strategies that counteract instances in which rescuers commit more than is feasible, desirable, expected, recommended, or compellingly necessary. How is overcommitment managed by professional frontline rescuers during hazardous medical evacuation and rescue situations? METHODS: In a qualitative, exploratory study, 9 focus group interviews were conducted with a total of 30 crewmembers from the Norwegian Helicopter Emergency Medical Service. RESULTS: In this second article in a series of 2 articles on overcommitment, 12 commitment-moderating factors are presented. Air ambulance personnel pointed at sociological, cognitive, and organizational elements that may influence their degree of commitment in challenging and hazardous rescue situations. CONCLUSION: Air ambulance personnel describe a team-based approach to adjust their level of commitment in medical evacuation and rescue missions. They rely on known, however important, nontechnical skills and organizational measures to combat overcommitment in demanding rescue situations. Some of their approaches to safe performance should be adoptable by other rescue units and less experienced voluntary, not-for-profit, rescue organizations.

The Concept of Overcommitment in Rescue Operations: Some Theoretical Aspects Based on Empirical Data.

OBJECTIVE: Studies on Norwegian avalanche rescue operations have indicated high-stake searching of avalanches during elevated risk conditions. We perceive these characteristics as a sign of overcommitment. The purpose of this study is to explore the concept of overcommitment in Norwegian medical evacuation and rescue operations. How can overcommitment be described and understood as a uniform concept in rescue operations based on empirical data? METHODS: In a qualitative, exploratory study, 9 focus group interviews were conducted with a total of 30 crewmembers from the Norwegian air ambulance service. RESULTS: In this first in a series of 2 articles, crewmembers' reflections on the concept of overcommitment, important factors to consider when balancing risk and benefit in every mission, and a number of causal factors are presented. A definition of overcommitment in the context of rescue activities is presented. CONCLUSION: Air ambulance personnel recognize overcommitment in a variety of situations. They broaden the concept to include both regular, everyday actions and hazardous rescue attempts in extraordinary incidents. The causal factors form recognizable constellations that may offer useful starting points for systems-based counteracting measures. The definition of overcommitment could provide a background for evaluation and learning in the rescue service.

An evaluation by the Norwegian Health Care Supervision Authorities of events involving death or injuries in maternity care.

INTRODUCTION: We aimed to determine how serious adverse events in obstetrics were assessed by supervision authorities. MATERIAL AND METHODS: We selected cases investigated by supervision authorities during 2009-2013. We analyzed information about who reported the event, the outcomes of the mother and infant, and whether events resulted from errors at the individual or system level. We also assessed whether the injuries could have been avoided. RESULTS: During the study period, there were 303 034 births in Norway, and supervision authorities investigated 338 adverse events in obstetric care. Of these, we studied 207 cases that involved a serious outcome for mother or infant. Five mothers (2.4%) and 88 infants (42.5%) died. Of the 207 events reported to the supervision authorities, patients or relatives reported 65.2%, hospitals reported 39.1%, and others reported 4.3%. In 8.7% of cases, events were reported by more than 1 source. The supervision authority assessments showed that 48.3% of the reported cases involved serious errors in the provision of health care, and a system error was the most common cause. We found that supervision authorities investigated significantly more events in small and medium-sized maternity units than in large units. Eighteen health personnel received reactions; 15 were given a warning, and 3 had their authority limited. We determined that 45.9% of the events were avoidable. CONCLUSIONS: The supervision authorities investigated 1 in 1000 births, mainly in response to complaints issued from patients or relatives. System errors were the most common cause of deficiencies in maternity care.

Room for improvement in maternity care. / Fødselsomsorgen kan bli bedre.

Adverse events still occur in maternity care, and many could be avoided. We must be better at learning from our own mistakes.

Organizational impact of governmental audit of blood transfusion services in Norway: A qualitative study.

Little is known about the organizational impact of supervisory activities in blood banks. We did a study with the aim to explore health professional's experiences with the external audit of blood transfusion services in Norway. The audit and supervision brought attention to deficiencies in systems and practices, and had been a catalyst for quality improvement. We identify facilitators and barriers to change. While audits can bring attention to known deficiencies, and trigger improvement processes which previously have not been prioritized, involvement of senior management is important to secure change across departments.

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

BACKGROUND: External inspections are widely used in health care as a means of improving the quality of care. However, the way external inspections affect the involved organization is poorly understood. A better understanding of these processes is important to improve our understanding of the varying effects of external inspections in different organizations. In turn, this can contribute to the development of more effective ways of conducting inspections. The way the inspecting organization states their grounds for noncompliant behavior and subsequently follows up to enforce the necessary changes can have implications for the inspected organization's change process. We explore how inspecting organizations express 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 analysis was guided by Donabedian's structure, process, and outcome model. RESULTS: Deficiencies in the management system in combination with clinical work processes was considered as nonconformity by the inspecting organizations. Two characteristic patterns were identified in the way observations led to a statement of nonconformity: one in which it was clearly demonstrated how deficiencies in the management system could affect clinical processes, and one in which this connection was not demonstrated. Two characteristic patterns were also identified in the way the inspecting organization followed up 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 one based on the documented changes in structural and process deficiencies addressed in the nonconformity statement. CONCLUSION: External inspections are performed to improve the quality of care. To accomplish this aim, we suggest that nonconformities should be grounded by observations that clearly demonstrate how deficiencies in the management system might affect the clinical processes, and that the inspection should be finalized based on documented changes in both structural and process deficiencies addressed in the nonconformity statement.