The Health Care Inspectorate and risk analysis
The Health Care Inspectorate
and risk analysis
The Health Care Inspectorate and risk analysis
The Health Care Inspectorate (IGZ) is the official regulatory body charged with safeguarding
the quality of care services, prevention activities and medical products. The Inspectorate will
take action against any care provider or manufacturer who fails to comply with current
legislation. Its approach is ‘risk-led’, i.e. the Inspectorate focuses on sectors and activities in
which the risks are greatest, as identified by a system of risk analysis.
This brochure provides further information about the various risk analyses conducted by
the Health Care Inspectorate. General information about the Inspectorate and its work can
be found at
Risk-led regulation
The Health Care Inspectorate is responsible for overseeing some 40,000 health care
institutions and private-sector companies, and approximately 800,000 individual health
care professionals. It applies a two-pronged approach. On the one hand, the Inspectorate
works proactively based on its own analysis of information provided by the field. On the
other, it works reactively in response to incoming incident reports and information from
various sources. In the Inspectorate’s proactive risk-led activities, the focus is on those
sectors, health care providers and manufacturers whose activities are seem to represent a
high (or higher than average) level of risk to patient safety. Alongside specific health-related
indicators such as patient outcomes, the Inspectorate gathers information relating to
operational and commercial aspects. In the reactive incident-led approach, the Inspectorate’s activities are prompted and guided by reports, complaints and other indications of
shortcomings in professional performance.
Five main types of information
The data gathered to support the Inspectorate’s risk analyses falls within five main categories:
1 Care-related indicators.
2 Corporate information.
3 Incident reports.
4 External signals.
5 The Inspectorate’s own observations and information received from other regulatory bodies.
Care-related indicators
Performance indicators offer an impression of the quality and safety of the care services
provided. The indicators relate to various aspects, including organizational structure, procedures and patient outcomes. The combined information is used to determine whether the
care process is organized in an effective and efficient manner, and whether the care itself is
of adequate quality. Care-related performance indicators vary from one sector to another.
Corporate information
Much of this type of information is gleaned from the annual ‘Social Responsibility Report’
of the organization concerned. All care providers who fall within the scope of the Health
Care Institutions Accreditation Act (Wet toelating zorginstellingen, WTZi) are required to produce
this report, in which they account for their health care activities. The report also provides
insight into the financial position of the organization, its personnel turnover and the rate
of staff absenteeism due to illness. All this ‘contextual information’ can have a great
predictive value with regard to current or potential risks within the care process itself.
Where a residential care home has a high rate of staff absenteeism, for example, the risk of
there being insufficient staff on duty to provide good, responsible care is that much greater.
Risk analyses
The Inspectorate conducts various risk analyses based on the information it receives both
directly from a care provider or manufacturer, and that which it receives from other sources
(such as incident reports and complaints). The results of the analyses are collated to form
performance ‘dashboards’. If the results of a risk analysis suggest a higher-than-average
level of risk, the Inspectorate will visit the care provider or manufacturer concerned. Based
on all available information and its own findings, it will determine whether the standard of
care provided can be termed ‘responsible’. The risk analyses and dashboards are subject to
ongoing development and refinement. Financial information is included so as to identify
any risks affecting quality of care which may result from the operational and commercial
management of an organization. This will enhance the predictive value of the risk analyses,
providing a more rounded impression of any situations in which there are unacceptable
risks to patient safety.
Incident reports
Each year, the Inspectorate receives some ten thousand reports of incidents and ‘nearmisses’, both from care providers and from members of the public. Care providers are
required by law to report certain types of incident, which the Inspectorate will always
investigate. The Inspectorate will also launch an investigation if it receives an unusually
high number of reports relating to a particular care provider or manufacturer, or if those
reports allege especially serious shortcomings. This ‘incident-led regulation’ is subject to
set procedures and guidelines (see
The Inspectorate also uses information from the reports for the purposes of risk-led
regulation. It assesses the degree to which institutions learn from incident reports and take
appropriate remedial action, and it identifies any common features within the reports
which may suggest a general trend.
Health Care Inspectorate
The Health Care Inspectorate and risk analysis
External signals
The Inspectorate’s risk analyses also draw on the results of various patient satisfaction
surveys and the comments left on public review sites. A pilot project has recently been
launched in which information is also drawn from the social media.
Observations and information received from other regulatory bodies
The findings of inspectors who have visited a location, as well as information (‘tip-offs’)
from other regulatory bodies are included in the dashboards. In certain cases, a (further)
inspection may be scheduled as a matter of priority.
Ongoing improvement
The Health Care Inspectorate is constantly striving to improve its risk analyses by combining
and collating the various types of information. Doing so provides an even more accurate
indication of situations which pose a risk to patient safety. For example, it can be useful to
set the patient outcomes of a care provider, especially one already under ‘special measures’,
alongside financial information. The Inspectorate has formulated a set of financial
indicators which have a high predictive value in terms of risks to the quality and safety of
care services.
The computer system in which the Inspectorate collates all information for risk analysis
purposes is known as IRIS. All data with predictive value is entered into the system, which
then produces the ‘dashboards’. IRIS reveals trends in the quality of health care services. It
generates a ‘league table’ in which health care providers and manufacturers are ranked
according to the degree of risk represented by their activities, whereby the Inspectorate can
prioritize its inspection visits accordingly. The system output also includes individual scores
for each of the performance indicators relating to safe and responsible care, together with
a list of any aspects which have been the subject of several reports and which therefore
warrant closer scrutiny during an inspection visit.
IRIS is still in development. The system now includes information relating to hospitals,
pharmacies, ambulatory mental health departments, psychiatric services within the judicial
system, residential care facilities and domiciliary care services. Information relating to
private clinics is to be added shortly. In time, IRIS will be expanded to include all health care
segments, institutions, organizations and individual care providers which fall under the
regulatory responsibility of the Health Care Inspectorate.
Health Care Inspectorate