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4.2 The RiDeM-H Concept with HFdFMEA

4.2.1 Human factors – How human factors can be identified,

4.2.1.2 CIRS-health-care.de

The database: CIRS-health-care.de78 is a "Means Cross CIRS in health". The system provides a closed password-protected area for healthcare facilities e.g.

hospitals and a public area where CIRS-cases are published. The system has been developed by Inworks GmbH79. Content responsible for the CIRS-health-care.de database itself is InPass80. Currently 400 institutions e.g. hospitals, from Germany and Austria are taking part and report here their critical incidents events or rather near misses.

At the cut-off date73 in total 194 so called TOP-events were reported and pub-lished in CIRS-health-care.de. But those are just TOP-events! The database behind the public monitored events consists of approximately 5.000 reported events81. An expert-team evaluates all reported events, e.g. risk rating (accord-ing to an FMEA they rate severity, occurrence and detection of the event where-as detection is not monitored officially. Also CIRS-health-care.de differentiates between “message available” and “message in process”. Below Table 17 and Table 18.give an overview on the search-criteria respectively what kind of infor-mation is requested.

Table 17: CIRS-health-care.de – Areas of expertise

78 Cirs-Health-Care: http://www.CIRS-health-care.de

79 Inworks GmbH, www.inworks.de, is market leader for quality and patient safety in hospitals and nursing facilities, the software Intrafox Healthcare is available since 2007. Inworks GmbH was founded in 1999 in Ulm by Oliver Zwirner, Markus Tannheimer, Bernd Hofer und André Reitz and is still in 100% equity.

80 InPass, Institute for Patient Safety and Team Training GmbH, founded by Dr. med. Marcus Rall, and sought-after expert for CIRS. For more details and company profile see http://health-care.inworks.de

81 Interview (07.11.2014): Dipl. - Wirtsch. -Ing. Tannheimer Markus, Managing Director & Senior Consultant, Inworks GmbH

area of expertise area of expertise area of expertise

all Hygiene and Environmental Medicine Pathology

Anesthesiology Internal Medicine Pharmacology

Anatomy Children and Adolescent Medicine Physical and Rehabilitative Medicine Occupational Health/ Child and adolescent psychiatry Physiology

Industrial Medicine Laboratory Medicine Psychiatry & Psychotherapy Ophthalmology Microbiology, Virology & Psychosomatic Medicine and

Biochemistry Infection Epidemiology Psychotherapy

Surgery Oral and Maxillofacial Surgery Radiology

Gynecology Neurosurgery Forensic Medicine

Ear-Nose and Throat Medicine (ENT) Neurology Radio Therapy

Dermatology & Social Diseases Nuclear Medicine Transfusion Medicine

Human Genetics Public Health Service Urology

OTHERS CIRS-database (cirs-health-care.de) - Catagories / search options

Table 18: CIRS-health-care.de – search criteria

Areas of expertise: The CIRS-health-care.de differentiates between 32 areas of expertise plus “others”, which includes each area that is not performed specif-ically; furthermore you have the possibility to assign an event to all areas (Table 9). Of course, it is important to know that one reported event can be assigned to more than one area of expertise. Due to this fact and according to the more de-tailed structured areas only 6.52% are related to Anaesthesiology, compared to CIRSmedical.de where 76.51% are assigned. Figure 25 gives an overview on the reported events and their assignment to the areas of expertise.

place contributory factor state

all all all

Hospital patient message in process

Hospital - outpatient / emergency room organisation message available

Hospital - area of operation task

Hospital - intensive care person / individual case-description

Hospital - operation room communication

Hospital - station working environment

Hospital - lanes equipment / material case-nr.

Hospital - monitoring room team & social factors

Hospital - other education

Preclinical / Emergency Medical Service

Preclinical / Emergency Medical Serv. - workplace professional category Preclinical / Emergency Medical Serv. - helicopter (affected)

Preclinical / Emergency Medical Serv. - ambulance all Preclinical / Emergency Medical Serv. - apartment doctor Preclinical / Emergency Medical Serv. - public space nursing staff Preclinical / Emergency Medical Serv. - other other staff Ambulance

Ambulance - labor

Ambulance - X-ray and others Ambulance - doctor's office Ambulance - waiting room Ambulance - other

CIRS-database (cirs-health-care.de) - Catagories / search options

Figure 25: CIRS-health-care.de – reported events to affected areas of expertise

Professional category: One of the main differences to the CIRSmedical.de is that one event can be assigned to more than one professional category. This is due to the understanding that an event effects different professions. Just 4.71%

out of all reported events are not assigned to a professional category (Figure 26).

Figure 26: CIRS-health-care.de – professional categories

Risk-rated events: Taking a look into the risk-rated top-events, 95.88% of the events are risk-rated by the expert-team. This is approximately 70% higher than at CIRSmedical.de, where just 15.72% of the reported events are risk-rated. In

the provided public report, however, only severity and occurrence are monitored.

In the background also the detection as well as information about effective pro-tection measures and its rating is recorded in the database. Those data were made available for this research by Inworks GmbH82.

Usually occurrence, severity and detection are classified on an ordinal scale from 1 to 10, which results in a Risk-Priority-Number RPNmax = 1000, CIRS-health-care.de uses an ordinal scale from 1 to 5 which results in a RPNmax = 125. The used risk-matrix and categorisation and ordinal scale for occurrence, severity and detection as well as the additional provided information about effec-tive protection measures is shown in Figure 27.

Figure 27: CIRS-health-care.de – “Risk Matrix” and risk-categorisation including for effective protection measures82

The place: Each reported event is assigned to a defined place that can be se-lected in the database (see Table 17). However, only the superordinate catego-ries were used as part of the evaluation (hospital, preclinical/emergency medical service, ambulance, other).

State of an event: as mentioned, cears-health-care.de differentiates as the CIRSmedical.de “between messages” available and “messages in process”.

82 Data provided by Dipl. - Wirtsch. -Ing. Tannheimer Markus, Managing Director & Senior Consult-ant, Inworks GmbH

each month 3 moderate 3 moderate 3

each week 4 high 4 high 2

daily 5 very high 5 very high 1

no effective 5

RISK Matrix - corresponding to CIRS-Health-Care Provider

Occurrence Severity Detection

of an Event of an Event of an Event

Contributory Factors: The contributory factors (see Table 20) ultimately pro-vide the basis for the human factors as used in the enhanced FMEA model. At least 98.88% of all reported top-events are assigned to one or more contributory factors. It is important to notice that more than one contributory factor can be assigned to the same event. The contributory factors are discussed in the follow-ing paragraph (4.2.1.3).

Figure 28: CIRS-health-care.de – contributory factors assigned to each event (Note: more than one category can be assigned to the same event; if there are no human factors assigned to one specific event, this is sup-plemented under “not assigned”)