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4.2 The RiDeM-H Concept with HFdFMEA

4.2.1 Human factors – How human factors can be identified,

4.2.1.1 CIRSmedical.de

The database: CIRSmedical.de is the reporting and learning system of the German medical profession for critical events in medicine. It is a public system and not compulsory.

The system is provided by Bundesärztekammer74 and by Kassenärztliche Bun-desvereinigung75. The organisation responsible for this system is Ärztliches Zentrum für Qualität in der Medizin76. The responsible Technic/SW/HW Provider is ProtecData AG77.

The information to be queried and summarized in CIRSmedical.de as well for that can be searched in the database itself, are given in Table 15.

Table 15: CIRSmedical.de – collected data

At the cut-off date72 in total 4.329 events were reported in CIRSmedical.de. All events are listed and of course, an expert-team evaluates each event and gives feedback on, e.g. risk rating (severity and occurrence of the event, comparable to the used terms in FMEA) and necessary measures that should be put in

74 Deutsche Bundesärztekammer (German Medical Association), http://www.bundesaerztekammer.de

75 Kassenärztliche Bundesvereinigung (National Association of Statutory Health Insurance Physi-cians), http://www.kbv.de/html

76 Ärztliches Zentrum für Qualität in der Medizin http://www.aezq.de

77 ProtecData AG, CH, http://www.ismed.ch/

area of expertise Age of the patient place contributory factor professional category

all (in case affected) all all all

General Medicine 0-1 hospital communication doctor/psychotherapist

Anaesthesiology 2-5 doctor's surgery education & training nursing staff

Ophthalmology 6-10 emergency medical service/ personal/individual factors other staff

Surgery 11-15 emergency rescue service of employee

Gynecology 16-20 home visit by the doctor team factors state

Dermatology & Social Diseases 21-30 nursing home organisation all

Ear-Nose-Throat (ENT) Medicine 31-40 other patient message in process

Internal Medicine 41-50 equipment/material message available

Children and Adolescent Medicine 51-60 Area of Supply context of the institution

Neurology 61-70 Emergency medication case-description

Orthopedy 71-80 Routine others

Psychiatry 81-90

Psychotherapy >90 Context frequency of occurrence case-nr.

Radiology unknown all not applicable

Urology Prevention daily

OTHERS Sex of the patient Diagnosis compilation monthly

(in case affected) Non-invasive measures annually

male (diagnosis/treatment) first time

female Invasive measures (diagnosis/treatment) unknown Organisation (interface, communication)

other context:

CIRS-database (CIRSmedicall.de) - Catagories / search options

place. It is differentiated between “message available” and “message in pro-cess”. Those which are in process haven’t been evaluated by the expert-team so far. It is important to know, that a reported event is assigned to just one profes-sional category, which means we can speak of a unique assignment. In general, if an event is not associated with any of the above categories (Table 15), this is performed under "not assigned".

Areas of expertise: The CIRSmedical.de differentiates between 15 areas of expertise plus “others”, which includes each area that is not performed specifi-cally (Table 16).

Table 16: CIRSmedical.de – Areas of Expertise, where events / incidents are re-ported

Although 8,2% of reported events are not assigned to a specific category, it is obvious that 76,51% of all events are in the area of Anaesthesiology. For further case-studies, the area of expertise surgery with 3,67% out of 100% has been chosen.

Risk-rated events: Taking a look into the reported risk-rated events within sur-gery, only 15.72% of the reported events are risk-rated. The rest, 84.28% of the reported events are not risk-rated. Risk-rated in this sense means, that severity and occurrence of the reported event are rated, from 1 to 5. The detection of an event isn’t taken into consideration. So as seen is that only a limited FMEA

Dermatology & Social Diseases 2 0,05%

Ear-Nose-Throat (ENT) Medicine 6 0,14%

The place: Each reported event is assigned to a defined place that can be se-lected in the database. For example for the area of expertise “surgery” (in total 159 reported events) 72.33% of all events happen in the hospital.

Figure 22: CIRSmedical.de –Where do events take place?

Further information:

Figure 23 gives an overview about surgery regarding:

 Professional category (doctor/psychotherapist, nursing staff, other staff)

 Time of day (weekday, weekend)

 Area of supply (emergency, routine)

 Sex of the patient (male, female)

 The state of an event (messages available, messages in process)

Place

relative [%]

hospital 115 72,33%

hoctor's surgery 5 3,14%

emergency med. serv. /rescue serv. 4 2,52%

home visit by the doctor 1 0,63%

nursing home 0,00%

other 29 18,24%

not assigned 5 3,14%

TOTAL 159 100,00%

no of reported events

Figure 23: CIRSmedical.de – information about all reported events (note: the allo-cation is done once per event, however there is no multiple appoint-ment for each 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.

Figure 24: CIRSmedical.de – Contributory Factors (Note: more than one category can be assigned to one event; if there are no human factors assigned to one specific event, this is supplemented under “not assigned”)

One major disadvantage of CIRSmedical.de is that in mostly cases there are no contributory factors associated to an event. In the case of surgery only 33.96%

of the reported events are assigned to contributory factors. Extrapolated to all reported events this means that in almost 66% of all reported events no assign-ment to contributory factors is made. In further calculations for the Risk Priority Number (RPN) taking into account the human factor this results in an extreme inaccuracy.

The contributory factors are discussed in paragraph (4.2.1.3).