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Established Patient Safety Indicators
Below a list of the PSIs, which have been established, that is characterised and evaluated by the WP4 Expert Group, is shown. A full description of the PSIs following the SAIFA is available on wwww.simpatie.org.
Evaluation of the PSIs
Eight experts from six nations evaluated the PSIs. The expert group initially conducted a structured review of each PSI and an independent assessment of each indicator evaluating the three dimensions: “Relevance”, “Validity and Reliability” and “Feasibility” of the indicators. The methodology for the structured review and the evaluation was given using the “Scheme for Evaluation of Indicators”. This evaluation was followed by a number of one hour telephone conferences, which served to discuss the PSIs, ensuring common understanding of the definitions and phrasing, and propose and decide on alterations and refinements. Only alteration for the new developed PSIs were made. Where it was found necessary descriptions of the PSIs were altered and re-circulated among the experts and the PSI was discussed again. The individual ratings on a scale ranging from 1 to 9 for each of the three dimensions of each PSI were also shared in telephone conferences.
As all PSIs had been rated, statistics for each dimension of the indicator was worked out and send to the expert group. The statistics formed the basis of the consensus decisions of recommendations for implementation of the PSIs according to the four categories previously described. Examples of statistics provided by the experts are shown below.
Recommendations for application of the PSIs established PSIs in Europe
The expert group’s consensus decisions on applications of the PSIs are shown in the table below. Recommendations are made according to the four possibilities described under step 4 above.
Generally the expert group found that the use of PSIs represent significant advances provided that a number of conditions described in the section on 'Specific Characteristics of Patient Safety Indicators' of this report are fulfilled. For various PSIs restrictions in the uses of the PSIs were recommended, please see table 9 below for these restrictions. The relative importance of each of the three dimensions proved to differ by individual PSIs.
Nine rate-based PSIs were recommended for implementation across Europe and 15 PSIs were recommended to be applied in parts of Europe, one of which was sentinel.
Four PSIs (number 3, 4, 5 and 25) were recommended as “At present not workable for implementation in Europe – Recommendation for future decision on implementation”. The expert group highly recommends methodological development of these four indicators in validation of the patient satisfaction survey instrument fundamental for the PSIs.
A number of the PSIs monitor patient harm. These PSIs are regarded sensitive to bias caused by patient disease severity, comorbidities and lifestyle factors. Validity and reliability of these data therefore depend on extensive collection of patient-related data and appropriate risk adjustment. The ambiguity of data definitions in e.g. recording of wound infections or prognostic factors in surgical patients points to problems in interpretation of data; especially if PSIs are to be used for external accountability.
Though comparability across Europe is necessary to develop patient safety, the use of PSIs imply methodological problems as the quality of indicator data was found to vary along a number of dimensions across institutions and nations in Europe. The expert group therefore recommends additional work concerning homogeneous and comparable data (data definitions) and investigation of indicator sensitivity and specificity.
Table 8. Recommendations of application of the Patient Safety Indicators
Table 8 pdf-file here
1. Immediately workable throughout the European health care systems. 2. Workable in parts of Europe.
3. At present not workable for implementation in Europe – Recommendation for future implementation
or decision on implementation. 4. Not suitable for implementation.
# Recommendation with restriction, please see Table 9, below for more details.
Table 9. Recommendations and restrictions regarding implementation of the Patient Safety Indicators
Aspects to be considered concerning application of the PSIs
In connection with the rating of the dimension 'Feasibility' of each PSI, the expert group discussed aspects such as data availability, the quality and features of administrative data present available, resources available, organisation of data collection in individual EU countries, legal systems concerning data collection individual data, etc. However these aspects are not systematically deepened and uncovered by WP4 for EU, but we found common traits leading to questions which need to be followed up upon if one wants to use the PSIs for comparison over time or even benchmarking building up a European databank. Some of these questions need to be taken carefully into account when planning to use the PSIs for comparison over time – some are more relevant if on wants to consider benchmarking. The questions uncovered in need of further investigation are:
- How is the quality of administrative data – does it match the definitions of the PSIs? Are further definitions needed to make the PSIs suitable for use? E.g. some obstetric PSIs refer to a specific method; “Delivery with instrument”, the use of instruments needs more detailed definition – Also for example for the PSIs on Decubitus ulcer and on infections no further definitions on the pathology is given, it is important to have common definition on both pathology and methods etc. The expert group discussed these aspects and differences in best practice were present both within specialities, professionals and nations in EU, for correct use of the PSIs the quality for the data must be comparable.
- How do local/national differences in opinions, perceptions, attitudes, beliefs, values, norms, assumptions influence decisions among clinicians, hospital managements, policy makers and planners etc. on embarking on systematic collection of personal data – focusing on the frequency of adverse events and errors for the sake of using PSIs to develop patient safety?
- What resources are needed in individual hospitals/nations of Europe to embark on using the PSIs for comparison or even for benchmarking?
- How is the data collection organised (centralised/decentralised)?
- Do individual hospitals/nations have informatics and reliable systems?
- How the availability of administrative data is – is it sufficient in its currents form?
- How do individual national legal systems allow data collection – especially with regard to data related to individuals?
- Not all European countries work with ICD-10 or DRG coding, how can this be handled for the PSIs where coding applies in case of benchmarking?
Table 5. List of established Patient Safety Indicators by WP4
INDICATOR CATEGORY AND NAME TYPE
INSTITUTION-WIDE PSIs
1. Measuring Hospital Standardised Mortality Rates New
2. Death in Low-Mortality DRGs Review
3. Patients Experiencing Adverse Events New
4. Patients Informed about an Adverse Event by the Staff New
5. Patients Experiences of Adverse Events Management New
6. Transition of Care – Patient’s Understanding of the Purpose of their Medication New
7. Institution-Wide use of Cultural Assessment New
8. Surveying the Development of the Patient Safety Culture New
THEME RELATED PSIs: “INFECTION CONTROL”
9. Selected Infections due to Medical Care Review
10. Hospital Acquired-Infection Registration – Post Operative Wound Infections New
11. Wound Infection Review
12. Ventilator Pneumonia Review
13. Hand Hygiene - Measured by the Alcohol Consumption New
14. Hand Hygiene - Staff’s Compliance with Guidelines for use of Jewellery New
THEME RELATED PSIs: “SURGICAL COMPLICATIONS”
15. Complications of Anesthesia Review
16. Foreign Body left during Procedure Review
17. Postoperative Pulmonary Embolism or Deep Vein Thrombosis Review
18. Postoperative Sepsis Review
19. Postoperative Haemorrhage or Haematoma Review
20. Postoperative Physiologic Metabolic Derangements Review
21. Postoperative Respiratory Failure Review
22. Accidental Puncture or Laceration Review
23. Wrong Site-Surgery Review
24. Medical Equipment-related Adverse Events Review
25. Patients experiencing Harmful Surgical Adverse Events New
INDICATOR CATEGORY AND NAME TYPE
THEME RELATED PSIs: “MEDICATION ERRORS”
26. Transfusion Reaction Review
27. Wrong Blood Type Review
28. Medication Error (Does not fulfil the criteria as an indicator, therefore deleted) Review
29. Electronic Trigger Tool - Surveillance of Adverse Drug Events New
THEME RELATED PSIs: “OBSTETRICS”
30. Obstetric Trauma – Vaginal Delivery without Instrument Review
31. Obstetric Trauma – Vaginal delivery with instrument Review
32. Obstetric trauma – Caesarean Delivery Review
33. Problems with Childbirth Review
34. Birth Trauma – Injury to Neonate Review
THEME RELATED PSIs: “IN-HOSPITAL FALL”
35. Postoperative Hip Fracture Review
36. In-Hospital Hip Fracture or Fall Review
37. Patient Falls Review
DIAGNOSE SPECIFIC AS WELL AS OTHER SPECIFIC PSIs
38. Decubitus Ulcer Review
39. Failure to Rescue Review
40. Iatrogenic Pneumothorax Review
41. Assessment of Suicidal Risk in Schizophrenic Patients New
42. Side Effect of Anti-Psychotic Treatment New
Table 6. Example of statistics bases on the ratings of the three dimensions for one PSI
Relevance and Appropriatness Validity and Reliablity Feasibility
Number of ratings 8 8 8
Median 7,50 5,50 5,00
Mode 8 4# 5
Percentiles 25 6,00 4,00 3,25
75 8,00 6,75 5,00
# Multiple modes exist. The smallest value is shown
Table 7. Example of statistics bases on the ratings of relevance and appropriateness for one PSI
Score Frequency Percent
Score 4: Medium degree of relevance and appropriateness 1 12,5
Score 6: Medium degree of relevance and appropriateness 2 25,0
Score 7: High degree of relevance and appropriateness 1 12,5
Score 8: High degree of relevance and appropriateness 4 50,0
Total 8 100,0
Diagram 1. Example of distribution of the ratings for “Relevance and Appropriateness” for one PSI
Rating
0
1
2
3
4
5
6
7
8
9
1 2 3 4 5 6 7 8
Individuel raters
INDICATOR CATEGORY AND NAME APPLICATION*
INSTITUTION-WIDE PSIs
1. Measuring Hospital Standardised Mortality Rates 2
2. Death in Low-Mortality DRGs 3
3. Patients Experiencing Adverse Events 3
4. Patients Informed about an Adverse Event by the Staff 3
5. Patients Experiences of Adverse Events Management 3
6. Transition of Care - Patient's Understanding of the Purpose of their Medication 2
7. Institution-Wide use of Cultural Assessment 1
8. Surveying the Development of the Patient Safety Culture 1
1. Immediately workable throughout the European health care systems. 2. Workable in parts of Europe. 3. At present not
THEME RELATED PSIs: “INFECTION CONTROL”
9. Selected Infections due to Medical Care 4
10. Hospital Acquired-Infection Registration – Post Operative Wound Infections 2
11. Wound Infection 1#
12. Ventilator Pneumonia 2#
13. Hand Hygiene - Measured by the Alcohol Consumption 1
14. Hand Hygiene - Staff’s Compliance with Guidelines for use of Jewellery 4
THEME RELATED PSIs: “SURGICAL COMPLICATIONS”
15. Complications of Anesthesia 2
16. Foreign Body left during Procedure 4
17. Postoperative Pulmonary Embolism or Deep Vein Thrombosis 4
18. Postoperative Sepsis 1
19. Postoperative Haemorrhage or Haematoma 1
20. Postoperative Physiologic Metabolic Derangements 2
21. Postoperative Respiratory Failure 2
22. Accidental Puncture or Laceration 3
23. Wrong Site-Surgery 3
24. Medical Equipment-related Adverse Events 3
25. Patients experiencing Harmful Surgical Adverse Events 3
THEME RELATED PSIs: “MEDICATION ERRORS”
26. Transfusion Reaction 2
27. Wrong Blood Type 2
28. Medication Error (Does not fulfil the criteria as an indicator, there fore deleted) -
29. Electronic Trigger Tool - Surveillance of Adverse Drug Events 2#
THEME RELATED PSIs: “OBSTETRICS”
30. Obstetric Trauma – Vaginal Delivery without Instrument 2#
31. Obstetric Trauma – Vaginal delivery with instrument 2#
32. Obstetric trauma – Caesarean Delivery 3
33. Problems with Childbirth 3
34. Birth Trauma – Injury to Neonate 2#
1. Immediately workable throughout the European health care systems. 2. Workable in parts of Europe. 3. At present not
THEME RELATED PSIs: “INFECTION CONTROL”
9. Selected Infections due to Medical Care 4
10. Hospital Acquired-Infection Registration – Post Operative Wound Infections 2
11. Wound Infection 1#
12. Ventilator Pneumonia 2#
13. Hand Hygiene - Measured by the Alcohol Consumption 1
14. Hand Hygiene - Staff’s Compliance with Guidelines for use of Jewellery 4
THEME RELATED PSIs: “SURGICAL COMPLICATIONS”
15. Complications of Anesthesia 2
16. Foreign Body left during Procedure 4
17. Postoperative Pulmonary Embolism or Deep Vein Thrombosis 4
18. Postoperative Sepsis 1
19. Postoperative Haemorrhage or Haematoma 1
20. Postoperative Physiologic Metabolic Derangements 2
21. Postoperative Respiratory Failure 2
22. Accidental Puncture or Laceration 3
23. Wrong Site-Surgery 3
24. Medical Equipment-related Adverse Events 3
25. Patients experiencing Harmful Surgical Adverse Events 3
THEME RELATED PSIs: “MEDICATION ERRORS”
26. Transfusion Reaction 2
27. Wrong Blood Type 2
28. Medication Error (Does not fulfil the criteria as an indicator, there fore deleted) -
29. Electronic Trigger Tool - Surveillance of Adverse Drug Events 2#
THEME RELATED PSIs: “OBSTETRICS”
30. Obstetric Trauma – Vaginal Delivery without Instrument 2#
31. Obstetric Trauma – Vaginal delivery with instrument 2#
32. Obstetric trauma – Caesarean Delivery 3
33. Problems with Childbirth 3
34. Birth Trauma – Injury to Neonate 2#
1. Immediately workable throughout the European health care systems. 2. Workable in parts of Europe. 3. At present not
THEME RELATED PSIs: “IN-HOSPITAL FALL”
35. Postoperative Hip Fracture 1
36. In-Hospital Hip Fracture or Fall 1
37. Patient Falls 4
DIAGNOSE SPECIFIC AS WELL AS OTHER SPECIFIC PSIs
38. Decubitus Ulcer 1
39. Failure to Rescue 4
40. Iatrogenic Pneumothorax 3
41. Assessment of Suicidal Risk in Schizophrenic Patients 2
42. Side Effect of Anti-Psychotic Treatment 2
1. Immediately workable throughout the European health care systems. 2. Workable in parts of Europe. 3. At present not
PSIs RECOMMENDED IMPLEMETED THROUGHOUT EUROPE
PSI 7. Institution-Wide use of Cultural Assessment
The general restrictions concerning data comparability apply, please see above.
PSI 8. Surveying the Development of the Patient Safety Culture
Comparison between units, departments and nations is only suitable provided that the same
method of measuring is used.
PSI 11. Wound Infections
Data definitions, data quality, and availability vary across institutions and across Europe, which
makes this PSI unsuitable for nation wide comparison or benchmarking under the current
conditions.
PSI 13. Hand Hygiene - Measured by the Alcohol Consumption
This PSI is only suitable for nation wide comparison or benchmarking provided the existence of
comparable data registration practice.
PSI 18. Postoperative Sepsis
This condition might be under-reported, which influences the data quality and comparison
between units, departments and nations.
PSI 19. Postoperative Haemorrhage or Haematoma
The general restrictions concerning data comparability apply, please see above.
PSIs RECOMMENDED IMPLEMETED IN PARTS OF EUROPE
PSI 1. Measuring Hospital Standardised Mortality
Data quality and availability varies across Europe. The data definition of the PSI is
recommended to be altered according to data availability in each country, which makes this PSI
unsuitable for cross-nation comparison under the current conditions.
PSI 4. Transition of Care - Patient's Understanding of the Purpose of their Medication
The general restrictions concerning data comparability apply, please see above.
PSI 8. Hospital Acquired-Infection Registration – Post Operative Wound Infections
This PSI is only suitable for nationwide comparison provided the existence of comparable data
registration practice.
PSI 10 Ventilator Pneumonia
Data must be risk adjusted prior to comparing patient outcomes across hospitals or providers.
Also data is recommend adjusted for time. This PSI is only suitable for nationwide comparison
provided the existence of comparable data registration practise
PSI 13. Complications of Anesthesia
The general restrictions concerning data comparability apply, please see above.
PSI 18. Postoperative Physiologic Metabolic Derangements
The general restrictions concerning data comparability apply, please see above.
SImPatIE WP4 – Establishing a set of Patients Safety Indicators
30
Table 9. Recommendations and restrictions regarding implementation of the PSIs (Cont.)
PSIs RECOMMENDED IMPLEMETED IN PARTS OF EUROPE
PSI 19. Postoperative Respiratory Failure
The general restrictions concerning data comparability apply, please see above.
PSI 24. Transfusion Reaction
Data quality for this PSI varies across Europe. This PSI is highly dependent upon a specific
reliable database. Administrative data are not viewed reliable enough to base this PSI upon.
PSI 25. Wrong Blood Type
The general restrictions concerning data comparability apply, please see above.
PSI 28. Electronic Trigger Tool - Surveillance of Adverse Drug Events
Data quality and availability varies across Europe. This PSI is highly dependent upon a well
developed health informatics system. The data definition of the PSI is recommended altered
according to data availability in each country, which makes this PSI unsuitable for cross EU
comparison under the current conditions.
PSI 29. Obstetric Trauma – Vaginal Delivery without Instrument
This PSI is only recommended implemented in countries where case mix and comorbidity can be
addressed. Comparison between units, departments and nations is only suitable provided the
existence of comparable data definitions and scoring method.
PSI 30. Obstetric Trauma – Vaginal delivery with instrument
This PSI is only recommended implemented in countries where case mix and comorbidity can be
addressed. Comparison between units, departments and nations is only suitable with the
provision comparable data definitions and scoring method.
PSI 33. Birth Trauma – Injury to Neonate
This PSI is only recommended implemented in countries where case mix and comorbidity can be
addressed. Comparison between units, departments and nations is only suitable provided that
comparable data definitions and scoring method can be procured.
PSI 34. Postoperative Hip Fracture
The general restrictions concerning data comparability apply, please see above.
PSI 35. In-Hospital Hip Fracture or Fall
The general restrictions concerning data comparability apply, please see above.
PSI 37. Decubitus Ulcer
Comparison between units, departments and nations is only suitable provided comparable data
definitions, registration and scoring method. This PSI is only suitable for nation wide comparison
provided comparable data registration practise
PSI 41. Assessment of Suicidal Risk in Schizophrenic Patients
The general restrictions concerning data comparability apply, please see above.
PSI 42. Side Effect of Anti-Psychotic Treatment
The general restrictions concerning data comparability apply, please see above.
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