Lack of clarity about 'patient safety incidents'

Alma Mulac; Solrun Elvik; Øystein Flesland

doi:10.4045/tidsskr.24.0053

Perspectives

Lack of clarity about 'patient safety incidents'

Norwegian

Alma Mulac, Solrun Elvik, Øystein Flesland

See All Articles

Alma Mulac

alma.mulac@farmasi.uio.no

Alma Mulac, PhD, pharmacist and postdoctoral fellow at the Department of Pharmacy, University of Oslo.

The author has completed the ICMJE form and declares no conflicts of interest.

See All Articles

Solrun Elvik

Solrun Elvik, pharmacist and senior advisor at the Norwegian Directorate of Health.

The author has completed the ICMJE form and declares no conflicts of interest.

See All Articles

Øystein Flesland

Øystein Flesland, MD, specialist in immunology and transfusion medicine, senior researcher at the Division of Surgery, Akershus University Hospital.

The author has completed the ICMJE form and declares no conflicts of interest.

Article

Two neonates are lying side by side in a maternity ward. A nurse notices that one infant has no name tag. The other infant is experiencing breathing difficulties, and it is discovered that the infant has received the wrong medication. Both are examples of incidents that should not happen, i.e. uønskede hendelser (patient safety incidents). How do current definitions differentiate between them?

In recent years, the term uønsket hendelse (patient safety incident) has been used in Norway in relation to events in the health service that should be prevented in the future. Meanwhile terms such as avvikshendelse (deviation), uheldig hendelse (untoward event) utilsiktet (unintended event) and nesten-hendelse (near miss) are used. Drawing on our extensive practical experience with reporting systems and research on patient safety incidents, we are of the opinion that such a plethora of terms leads to a lack of clarity and threatens patient safety. In this article, we propose a classification that both simplifies and clarifies the terms.

Challenging terminology development

Our experience is that there are different understandings of the term uønsket hendelse (patient safety incident) among health personnel, specialists, researchers and healthcare administrators. This may be because the term has no precise definition or that the definition is difficult to understand.

A lack of clear, common definitions means that local authorities, hospital trusts, institutions and specialist groups develop and use their own definitions based on their interpretations of the regulations and specialist literature

Most of those working in the health service have been involved in or affected by a patient safety incident. Such events can occur in health care as a result of errors in medication management, surgery or diagnostics, for example. A lack of clear, common definitions means that local authorities, hospital trusts, institutions and specialist groups develop and use their own definitions based on their interpretations of the regulations and literature (1). For instance, some hospital trusts use 'patient safety incident' as a collective term for events that have or could have resulted in patient harm (2, 3), while in academic circles, the term is used for events that have resulted in patient harm (4).

Need for a review

In 2023, the expert group on the reporting system for serious patient safety incidents in the healthcare systems submitted its report Fra varsel til læring og forbedring (From reporting to learning and improvement) (5). The group has evaluated Norwegian reporting systems and proposes, among other things, a new system for reporting serious patient safety incidents in the healthcare service. In the report, the committee points out that the terms uønskede hendelser (patient safety incident), nesten-alvorlige hendelser (near serious events) and nesten hendelser (near misses) should be defined in the legislation and described in more detail in national guidelines. Meanwhile, the expert group defined several terms in the report. This can be interpreted as an attempt to sort out the terms, but is this actually the result?

The expert group proposes a broad definition of adverse events, including: '…alvorlige hendelser (serious events), nesten-alvorlige hendelser (near serious events), nesten-hendelser (near misses), bagatellmessige hendelser (minor events), hendelser uten alvorlig skade (non-serious events), etc.' (5). How should health personnel and health service managers interpret events described as 'minor'? It is inappropriate to use one term for both the type of event and the consequence for a patient, as, for example in nesten-alvorlige hendelser (near serious events). This makes it difficult for health service employees to understand which events must be reported and where to report them. Where does the 'neonate with no name tag' fit into this wide-ranging definition? And is a hendelse uten alvorlig skade (non-serious event) the same as a nesten-alvorlig hendelse (near serious event) or something different? And can all this be evaluated in just a few minutes, which is the time health personnel often have at their disposal to report an event?

An attempt at simplification

Rather than this mixed bag, we propose an alternative classification with three types of incidents inspired by the World Health Organization's guidance on the classification of patient safety incidents (6).

Our proposal differentiates between whether an incident has reached the patient or not. Incidents that do not reach the patient are classified as nesten-hendelser (near misses). Incidents that reach the patient are differentiated according to whether the incident has resulted in patient harm or not: i.e. skadelig hendelse (harmful incident) and ikke-skadelig hendelse (no harm incident). See examples in Figure 1 of the three main types of incidents exemplified by patient safety incidents related to medications. Moreover, the three types of incidents should be classified according to severity and preventability based on, for example, the Norwegian coding system for adverse events (7).

Such a classification system that differentiates between incidents that reach the patient and those that do not, can promote a common understanding and a simpler and more accurate classification. It may also mean that the most serious reports of patient harm are not overshadowed by less serious reports. Moreover, the classification can simplify data extraction and provide a broader basis for learning and improvement.

Different understandings of terminology are nothing new

Patient safety is a relatively new field that came into being at the turn of the millennium with the report, To Err Is Human. The report presented alarming figures on patient harm and deaths as a result of errors in the health service (8).

Since then, terms related to patient safety have undergone a development. As early as 2000, Peter F. Hjort tackled the problematic issue of different terms in the wake of the global patient safety movement (9). Hjort replaced feil (error) with uheldig hendelse (untoward event), a neutral term that does not allocate blame.

In 2010, the Norwegian National Unit for Patient Safety (10) carried out an evaluation of the terms related to patient safety. This report showed early on that there are many names for the same concept. In addition to 'patient safety incident' and 'untoward event', there is mention of 'unintended event', which is also used by Danish experts in their work on patient safety. The terms describe an event that could have led to patient harm or has led to patient harm but says nothing about the consequence for the patient.

Avvik (deviation) is another term with which Norwegian health personnel are familiar. However, deviation is associated with the failure to meet specified requirements or denotes violations of laws, regulations and protocols. In recent years, there has apparently been informal agreement to use 'patient safety incident', but there is no agreement about what the term entails.

Unclear terminology has several implications

Reporting systems in the health service are characterised by underreporting, and the number of incidents reported only represents the tip of the iceberg (11). A survey conducted by the Norwegian System of Patient Injury Compensation showed that only 33 per cent of the cases involving patient injury compensation were found in the hospitals' reporting systems (12). Thus the hospitals may have lost opportunities to learn from errors and improve practices. If there is systematic underreporting of certain types of incidents or specialist areas, this may lead to incorrect prioritisation of efforts to improve patient safety.

One explanation for the underreporting may be a lack of a common understanding of the term 'patient safety incident'. For example, the missing name tag may be classified as an administrative incident and not a patient-related incident (13). Consequently, the uncertainty of both the person reporting and executive officers may undermine the learning outcomes from the reporting systems.

If there is systematic underreporting of certain types of incidents or specialist areas, this may lead to incorrect prioritisation of efforts to improve patient safety

Norway greatly benefits from comparing and learning about patient safety work in other countries, but also plays a contributing role internationally. In order to utilise international data from publications on adverse events and patient safety incidents, which are established terms in the literature, an appropriate translation of the terms into Norwegian is required.

The international literature often defines 'adverse event' as an incident that has resulted in patient harm. 'Patient safety incident' has a wider scope than adverse event and includes incidents regardless of whether they have reached the patient or resulted in harm. Thus 'patient safety incident' can be used as the translation of uønsket hendelse.

Currently, therefore, there does not seem to be a suitable Norwegian term for 'adverse event'. An example that illustrates this is the use of the Global Trigger Tool. This tool measures adverse events (incidents that result in patient harm) per 1 000 patient days, per 100 admissions, and the percentage of admissions with an adverse event (14, 15). In the absence of a better Norwegian translation of 'adverse event', we measure pasientskade (patient harm) and not events that have resulted in patient harm (16). Should we continue to translate 'adverse event' as pasientskade (patient harm), or should we introduce a suitable term that indicates that this relates to an incident and not merely the consequence of an incident, for example skadelig hendelse (harmful incident) as we propose? Clearer terminology would enable comparisons of the number of incidents resulting in patient harm across national borders and studies (17).

'Do not let a hundred flowers bloom'

Patient safety is a rapidly evolving field and is the subject of increasing research (18). Nevertheless, there is a lack of monitoring and discussion in relation to the development of terminology in the field.

We see a need for a national expert group to propose common terminology, classification and standardisation nationally and internationally. Weeding out unnecessary terms is also important to allow the technological advancement to contribute to automatised classification and analysis of adverse events.

While politicians are tasked with deciding the way forward in relation to incident reporting systems, the time is ripe to sort out the terminology.

References

1.
Hofstad E. Liten nytte av å melde avvik. Sykepleien 12.3.2015. https://sykepleien.no/2015/03/1-av-2-ser-ikke-nytten-av-melde Accessed 1.12.2023.
2.
Oslo Universitetssykehus. Uønskede hendelser. https://www.oslo-universitetssykehus.no/fag-og-forskning/kvalitet/uonskede-hendelser Accessed 1.12.2023.
3.
Helse Bergen. Uønskede hendelser - melding, saksbehandling og læring. https://kvalitet.helse-bergen.no/docs/pub/dok63738.pdf Accessed 13.12.2023.
4.
Aase K. Pasientsikkerhet. Oslo: Universitetsforlaget, 2022.
5.
Helse- og omsorgsdepartementet. Fra varsel til læring og forbedring. https://www.regjeringen.no/no/dokumenter/fra-varsel-tillaring-og-forbedring/id2971072/ Accessed 11.3.2024.
6.
WHO. Patient safety incident reporting and learning systems: technical report and guidance. https://www.who.int/publications/i/item/9789240010338 Accessed 11.3.2024.
7.
Helsedirektoratet. Norsk kodeverk for uønskede pasienthendelser. https://www.helsedirektoratet.no/rapporter/norsk-kodeverkfor-uonskede-pasienthendelser/Norsk%20kodeverk%20for%20u%C3%B8nskede%20pasienthendelser.pdf/_/attachment/inline/e95247b1-bdb4-463b-b730-5a09398db917:88e99f1e911c29fd8101025ad12f685eef995b9c/Norsk%20kodeverk%20for%20u%C3%B8nskede%20pasienthendelser.pdf Accessed 11.1.2024.
8.
Institute of Medicine (US) Committee on Quality of Health Care in America. Kohn LT, Corrigan JM, Donaldson MS, red. To Err is Human: Building a Safer Health System. Washington DC: National Academies Press, 2000.
9.
Hjort PF. Uheldige hendelser i helsetjenesten–forebygging og håndtering. Tidsskr Nor Lægeforen 2000; 120: 3184–9. [PubMed]
10.
Nasjonalt kunnskapssenter for helsetjenesten. Kartlegging av begrepet pasientsikkerhet. https://www.fhi.no/globalassets/dokumenterfiler/notater/2010/notat_2010_kartlegging-av-begrepet-pasientsikkerhet_v2.pdf Accessed 11.3.2024.
11.
Mulac A, Taxis K, Hagesaether E et al. Severe and fatal medication errors in hospitals: findings from the Norwegian Incident Reporting System. Eur J Hosp Pharm Sci Pract 2021; 28 (Suppl 2): e56–61. [PubMed][CrossRef]
12.
Norsk Pasientskadeerstatning. 33 prosent av NPE-saker blir funnet igjen i sykehusenes meldesystemer. https://www.npe.no/no/Helsepersonell/pasientsikkerhet/rapporter/33-prosent-av-npe-saker-blir-funnet-igjen-i-sykehusenes-meldesystemer/ Accessed 11.1.2024.
13.
Riksrevisjonen. Sak 1: Helseforetakenes håndtering av uønskede hendelser. https://www.riksrevisjonen.no/globalassets/rapporter/no-2016-2017/undersokelse-av-helseforetakenes-handtering-av-uonskede-hendelser.pdf Accessed 11.1.2024.
14.
Griffin FA, Resar RK. IHI Global Trigger Tool for Measuring Adverse Events. Cambridge, MA: Institute for Healthcare Improvement, 2009.
15.
Hibbert PD, Molloy CJ, Schultz TJ et al. Comparing rates of adverse events detected in incident reporting and the Global Trigger Tool: a systematic review. Int J Qual Health Care 2023; 35. doi: 10.1093/intqhc/mzad056. [PubMed][CrossRef]
16.
I trygge hender. Praktisk informasjon for Global Trigger Tool-team. https://www.itryggehender24-7.no/malinger/global-trigger-tool-gtt/praktisk-informasjon-for-global-trigger-tool-team Accessed 1.12.2023.
17.
Deilkås ET, Haugen M, Risberg MB et al. Longitudinal rates of hospital adverse events that contributed to death in Norway and Sweden from 2013 to 2018. J Patient Saf Risk Manag 2021; 26: 153–60. [CrossRef]
18.
Illingworth J, Shaw A, Fernandez Crespo R et al. Global State of Patient Safety 2023. Imperial College London 2023. https://www.imperial.ac.uk/Stories/global-state-of-patient-safety/ Accessed 11.3.2024.

Comments ( 1 )

Dette kommentarfeltet modereres, men kommentarer blir ikke redaksjonelt behandlet ut over å sikre at de følger retningslinjer for vårt kommentarfelt.

15.05.2024:

Tusen takk for nyttig artikkel. Artikkelen påpeker rettmessig at det er nyttig å skille mellom uønskede hendelser som når pasienten og de som ikke gjør det, og om hendelsen bidro til skade. Dette forholdet ivaretas i klassifiseringen for uønskede hendelser knyttet til medisinering, som er utviklet av til National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) i USA (1). I Norge så har NCC MERP sin indeks for klassifiseringen av uønskede hendelser vært benyttet til å gradere alvoret av en pasientskades konsekvenser siden 2011, ved nasjonal måling av pasientskade med Global Trigger Tool (GTT) (2, 3). I GTT målingen så er NCC MERP indeksen tilpasset og inneholder kun kategoriene E, F, G, H og I. Det er disse kategoriene som beskriver skade (Tabell 1). I tillegg er følgende utrykk «En feil som bidro til eller førte til ...» fjernet i disse kategoriene, fordi GTT kun har som formål å fokusere på skadelige utfall for pasienter i et systemperspektiv (2).

Tabell 1. NCC MERP indeks kategorier som inngår i GTT metoden.
Kategori E: Forbigående skade som krevde behandling
Kategori F: Forbigående skade som førte til forlenget sykehusopphold
Kategori G: Langvarig skade – varig mèn
Kategori H: Livreddende behandlingstiltak var nødvendig
Kategori I: Pasienten døde

Kategoriene A, B, C, og D i NCC MERP som er utelatt i GTT metoden, nyanserer om en uønsket hendelse førte til pasientskade eller ikke. Disse kategoriene dekker muligens det forfatterne i kommentarartikkelen etterlyser. De foreslår i tillegg at begrepet «pasientskade» ved nasjonal måling av pasientskade med GTT endres, for å kunne kategorisere hendelsene som resulterer i skade.

Tabell 2. NCC MERP indeksen kategorier som er utelatt i GTT metoden.
Kategori A: Omstendigheter og hendelser som kan forårsake feil
Kategori B: En feil som ikke rammet pasienten
Kategori C: En feil som rammet pasienten, men som ikke forårsaket skade
Kategori D: En feil som rammet pasienten og krevde overvåking eller inngripen for å sikre at pasienten ikke ble påført skade

GTT metoden definerer pasientskade som utilsiktet fysisk skade som har oppstått som et resultat av medisinsk behandling eller som behandlingen har bidratt til, som krever ytterligere overvåking, behandling eller sykehusinnleggelse, eller som har dødelig utgang (2). Ved GTT undersøkelsen er kategorisering av alvorlighet begrenset til konsekvensen en pasientskade har for pasienten. GTT metoden har som mål å måle omfang av skade for pasientene (4). Målet er ikke å avdekke mekanismer for skade, selv om det skjer en begrenset kategorisering av skadetyper. Målet er heller ikke å vurdere om individer har gjort feil. GTT kategoriserer derfor ikke alvorlighet knyttet til hendelsen som førte til pasientskade, og om det har skjedd en feil.

Litteratur
1. Hartwig SC, Denger SD, Schneider PJ. Severity-indexed, incident report-based medication error-reporting program. Am J Hosp Pharm. 1991; 48: 2611-6.
2. Veileder for bruk av Global Trigger Tool tilpasset norske forhold. Helsedirektoratet: Helsedirektoratet; 2017.
3. Deilkas ET, Bukholm G, Lindstrom JC, Haugen M. Monitoring adverse events in Norwegian hospitals from 2010 to 2013. BMJ open. 2015; 5(12): e008576.
4. Resar RK, Rozich JD, Classen D. Methodology and rationale for the measurement of harm with trigger tools. Qual Saf Health Care. 2003; 12(90002): ii39-45.

This article was published more than 12 months ago and we have therefore closed it for new comments.

Published: 15 April 2024

Tidsskr Nor Legeforen 15 April 2024 Vol. 144.

doi:

10.4045/tidsskr.24.0053

Received 25.1.2024, first revision submitted 20.2.2024, accepted 11.3.2024.

Published: 15 April 2024

Tidsskr Nor Legeforen 2024 Vol. 144.

doi: 10.4045/tidsskr.24.0053

Received 25.1.2024, first revision submitted 20.2.2024, accepted 11.3.2024.

PDF

Print

Lack of clarity about 'patient safety incidents'

Challenging terminology development

Need for a review

An attempt at simplification

Different understandings of terminology are nothing new

Unclear terminology has several implications

'Do not let a hundred flowers bloom'

Oppklaring om begrepene «uønskede hendelser» og «pasientskade»

Recent Articles