Deviations* | Dataset 1 (n = 41) | Dataset 2 (n = 30) | Dataset 3 (n = 100) | Total (n = 171) | Percentage of total |
Validation period 1 | Validation period 2 | ||||
Total preoperative deviations | 68 | 153 | 221 | 37.3 | |
Informed consent procedure | 13 | 26 | 39 | 6.6 | |
Informed consent anaesthesia | 16 | 42 | 58 | 9.8 | |
Information | 8 | 9 | 17 | 2.9 | |
Instructions anaesthesiologist | 1 | 5 | 6 | 1.0 | |
Laboratory tests and blood products | 5 | 13 | 18 | 3.0 | |
Pressure area protection protocol | 10 | 29 | 39 | 6.6 | |
Medication (including premedication) | 15 | 29 | 44 | 7.4 | |
Total peroperative deviations | 52 | 69 | 129 | 250 | 42.2 |
Logistics OR, positioning of patient | 6 | 6 | 1 | 13 | 2.2 |
Information | 7 | 10 | 11 | 28 | 4.7 |
Personnel | 7 | 11 | 10 | 28 | 4.7 |
Communication | 6 | 10 | 6 | 22 | 3.7 |
Instruments/material/equipment presence | 17 | 7 | 21 | 45 | 7.6 |
Instruments/material/equipment functioning | 8 | 22 | 35 | 65 | 11.0 |
Patient-related | 1 | 2 | 4 | 7 | 1.2 |
Medication | – | 1 | 41 | 42 | 7.1 |
Total postoperative deviations | 29 | 93 | 122 | 20.6 | |
Operation report in medical record | 1 | 3 | 4 | 0.7 | |
Instructions surgeon | 6 | 6 | 12 | 2.0 | |
Instructions anaesthesiologist | 3 | 13 | 16 | 2.7 | |
(Protocol) information | 11 | 46 | 57 | 9.6 | |
Technical | 1 | – | 1 | 0.2 | |
Patient-related | 1 | 4 | 5 | 0.8 | |
Discharge letter/outpatient appointments | 4 | 9 | 13 | 2.2 | |
Medication at discharge | 2 | 12 | 14 | 2.4 | |
Total no | 52 | 166 | 375 | 593 | 100.0 |
*Deviations represent not adverse events but merely deviations from the optimal and/or appropriate care process and imply potential safety hazard. The outcome of the deviations was not monitored.