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The European protocol for surveillance of surgical site infections Workshop “European surveillance of healthcare-associated infections: theory and practice” Sofia, 26 – 27 November 2009

The European protocol for surveillance of surgical site infections Workshop European surveillance of healthcare-associated infections: theory and practice

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Page 1: The European protocol for surveillance of surgical site infections Workshop European surveillance of healthcare-associated infections: theory and practice

The European protocol for surveillance of surgical site infections

Workshop “European surveillance of healthcare-associated infections: theory and practice”

Sofia, 26 – 27 November 2009

Page 2: The European protocol for surveillance of surgical site infections Workshop European surveillance of healthcare-associated infections: theory and practice

Outline

Definition of surveillance

Objectives of European surgical site infection (SSI)

surveillance

Case definitions for SSIs

Categories of surgical procedures under surveillance

The National Healthcare Safety Network (NHSN) risk

index

Information to be collected

Indicators of SSI incidence

Page 3: The European protocol for surveillance of surgical site infections Workshop European surveillance of healthcare-associated infections: theory and practice

Definition of surveillance

Ongoing, systematic collection, analysis, and

interpretation of health data

Closely integrated with the timely dissemination

to those who need to know

Application of the data to preventing and

controlling disease

Thacker SB, Berkelman RL. Epidemiol Rev 1998

Page 4: The European protocol for surveillance of surgical site infections Workshop European surveillance of healthcare-associated infections: theory and practice

Why surveillance of SSIs? At the level of the hospital Target infection control activity Drive change in practice Develop & underpin partnerships with clinical teams

At the regional/national level Follow up epidemiological trends in time Identify and follow up risk factors of SSIs Improve the quality of data collection

At the European level Work towards comparable surveillance methods Describe and monitor the epidemiology of SSIs at European

level Draw up European reference tables for inter-hospital comparisons of

risk-adjusted SSI rates Contribute to the extension of SSI surveillance in the European Union

Page 5: The European protocol for surveillance of surgical site infections Workshop European surveillance of healthcare-associated infections: theory and practice

General characteristics of European SSI surveillance

Patient-based surveillance

Prospective surveillance

Minimum period of three months recommended

Participation on voluntary basis

Page 6: The European protocol for surveillance of surgical site infections Workshop European surveillance of healthcare-associated infections: theory and practice

Case definitions for SSIs

To compare results must identify SSIs consistently

May not capture every SSI

European definitions based on CDC, USA, definitions

Widely adoptedInternational comparisons

Page 7: The European protocol for surveillance of surgical site infections Workshop European surveillance of healthcare-associated infections: theory and practice

European definitions of SSIs

Superficial incisionalinvolves only skin or subcutaneous tissueoccurs within 30 days of surgery (with/without implant)

Deep incisionalinvolves fascial or muscle layersoccurs within 30 days, implants within 1 year

Organ/spacepart of anatomy opened / manipulated infection appears related to surgeryoccurs within 30 days, implants within 1 year

A nonhuman-derived object,

material, or tissue (eg, hip

prosthesis) that is permanently

placed in a patient during an

operative procedure and is not

routinely manipulated for

diagnostic or therapeutic

purposes

Page 8: The European protocol for surveillance of surgical site infections Workshop European surveillance of healthcare-associated infections: theory and practice
Page 9: The European protocol for surveillance of surgical site infections Workshop European surveillance of healthcare-associated infections: theory and practice

Superficial Incisional SSI

Must meet one of the following criteria: 1. Purulent drainage from superficial incision 2. Organisms isolated from a culture of:

fluid or tissue from superficial incision

3. At least 1 sign or symptom of infection : pain, tenderness, localised swelling, redness, heat and Incision deliberately opened by surgeon 4. Clinicians diagnosis of superficial incisional

unless incision is

culture-negative

Page 10: The European protocol for surveillance of surgical site infections Workshop European surveillance of healthcare-associated infections: theory and practice

Deep Incisional SSI

Must meet one of the following criteria: 1. Purulent drainage from deep incision 2. Deep incision spontaneously dehisces or Incision deliberately opened by surgeon in the presence of at least 1 sign or symptom of infection: fever (>38 C), pain, tenderness 3. Abscess or other evidence of infection in deep

incision: direct examination or re-operation or histopathology or radiology

4. Clinicians diagnosis of deep incisional

unless incision

is culture-

negative

Page 11: The European protocol for surveillance of surgical site infections Workshop European surveillance of healthcare-associated infections: theory and practice

Organ/Space SSI

Must meet one of the following criteria: 1. Purulent drainage from a drain placed into the

organ/space 2. Organisms isolated from a culture of:

fluid or tissue in the organ/space

3. Abscess or other evidence of infection involving the organ/space: direct examination or re-operation or histopathology or

radiology

4. Clinicians diagnosis of organ/space SSI

Page 12: The European protocol for surveillance of surgical site infections Workshop European surveillance of healthcare-associated infections: theory and practice

Tips on applying the definitions of SSIs!

» Encourage medical and nursing staff to document clinical signs and symptoms in notes and bacteriology request forms

» Develop clear guidance on when a wound swab should be taken: there should be some signs or symptoms of infection

» Check significance of positive microbiology cultures with microbiologist

» Visually check wounds if information from clinical staff/patients notes is inconclusive

» If a patient is prescribed antibiotics do not assume these are for SSI – check with clinician

Page 13: The European protocol for surveillance of surgical site infections Workshop European surveillance of healthcare-associated infections: theory and practice

Categories of surgical procedures under surveillance

NHSN1 category

Description ICD-9-CM 2001 codes included in the category

CBGB Coronary artery bypass grafting with both chest and donor site incisions Chest procedure to perform direct revascularisation of the heart; includes obtaining suitable vein from donor site for grafting

36.10-36.14, 36.19

CBGC Coronary artery bypass grafting with chest incision only Chest procedure to perform direct vascularisation of the heart using, e.g, the internal mammary artery

36.15-36.17, 36.2

CHOL Cholecystectomy Removal of gallbladder; includes procedures performed using the laparoscope

51.03, 51.04, 51.2-51.24

COLO Colon surgery Incision, resection or anastomosis of the large intestine; includes large-to-small and small-to-large bowel anastomosis

45.00, 45.03, 45.41, 45.49, 45.50, 45.52, 45.7-45.90, 45.92-45.95, 46.0, 46.03, 46.04, 46.1-46.14, 46.43, 46.52, 46.75, 46.76, 46.91, 46.92, 46.94, 48.5, 48.6-48.69

CSEC Caesarean section 74.0-74.2, 74.4-74.99HPRO Hip prosthesis

Arthroplasty of hip81.51-81.53

KPRO Knee prosthesis Arthroplasty of knee

81.54, 81.55

LAM Laminectomy Exploration or decompression of spinal cord through excision or incision into vertebral structure

03.0-03.09, 80.50, 80.51, 80.59

1 National Healthcare Safety Network , USA

Page 14: The European protocol for surveillance of surgical site infections Workshop European surveillance of healthcare-associated infections: theory and practice

How to compare SSI rates? Case-mix adjustment needed

A possible approach the National Healthcare Safety Network risk index

It is weighted by information on:

Risk of contamination of the wound: wound contamination class

Patient’s physical condition: American Society of Anaesthesiology (ASA) physical status classification

Duration of operation

Page 15: The European protocol for surveillance of surgical site infections Workshop European surveillance of healthcare-associated infections: theory and practice

How to build the NHSN risk index? The wound contamination class

1. Clean:

uninfected operative wound and respiratory, alimentary, genital,

or urinary tract not entered; operative incisional wounds that follow non-

penetrating trauma should be included in this category, e.g. coronary artery

bypass graft

2. Clean-contaminated: respiratory, alimentary, genital, or urinary tract entered, under controlled

condition and without unusual contamination, e.g. cholecystectomy

3. Contaminated:

open, fresh, accidental wound; operations with major breaks in sterile technique;

incisions in which acute, non purulent inflammation encountered, e.g. open bone

fracture just after the trauma

4. Dirty or infected wound:

old traumatic wound with retained devitalised tissue and wound that involves

existing clinical infection or perforated viscera, e.g. revision of infected hip prosthesis

Page 16: The European protocol for surveillance of surgical site infections Workshop European surveillance of healthcare-associated infections: theory and practice

How to build the NHSN risk index? The physical status classification developed by the

American Society of Anaesthesiology (ASA score)

1. Normally healthy patient

2. Patient with mild systemic disease

3. Patient with severe systemic disease

4. Patient with incapacitating systemic disease that is a constant threat to life

5. Moribund patient who is not expected to survive for 24 hours with or without operation

Page 17: The European protocol for surveillance of surgical site infections Workshop European surveillance of healthcare-associated infections: theory and practice

How to build the NHSN risk index? Duration of operation

NHSN category 75th percentile cut-off value in hours

CBGB 5

CBGC 4

CHOL 2

COLO 3

CSEC 1

HPRO 2

KPRO 2

LAM 2

Cut-off values for duration of operative procedure categories

In case of a reintervention within

72 hours after the primary

operation, the duration of

reintervention need to be added

to the duration of the primary

operation

Page 18: The European protocol for surveillance of surgical site infections Workshop European surveillance of healthcare-associated infections: theory and practice

How to build the NHSN risk index?

Variables for stratification

NHSN risk indexStratification

points

Wound classification Class > 2 1

ASA score > 2 1

Duration of operation > 75th percentile 1

Stratification points for the variables of the NHSN risk index

Four levels of risk are defined (levels 0 to

3) using a combination of the three

variables

Page 19: The European protocol for surveillance of surgical site infections Workshop European surveillance of healthcare-associated infections: theory and practice

Information to be collected

Page 20: The European protocol for surveillance of surgical site infections Workshop European surveillance of healthcare-associated infections: theory and practice

Surgical Site Infection Surveillance

Operative Procedure Data Collection Form

GENERAL DATA

Hospital Code

Operative Procedure ID

Age at Date of Operation (years) |__|__|__|

Gender Male |__| Female |__| Unknown |__|

d d / m m / y y y y

Date of Admission |_____|________|______________| Discharge Status alive |__| death |__|

Date of Operation |_____|________|______________| NNIS Operation Code |__|

__|__|__|

Date of Discharge or |_____|________|______________| Date of Last Follow-Up in Hospital ICD-9-CM Operation Code |__|__| |__|__|Date of Last Follow- |_____|________|______________|Up Post Discharge

Page 21: The European protocol for surveillance of surgical site infections Workshop European surveillance of healthcare-associated infections: theory and practice

Surgical Site Infection Surveillance

Operative Procedure Data Collection Form

STRATIFICATION AND PREOPERATIVE DATA

Endoscopic Procedure? Yes |__| No |__| ASA Physical Status Classification

Normal healthy patient 1 |__|

Wound Contamination Class Mild systemic disease 2 |__|

Clean 1 |__| Severe systemic disease 3 |__|

Clean-Contaminated 2 |__| Incapacitating systemic disease 4 |__|

Contaminated 3 |__| Moribund patient 5 |__|

Dirty/Infected 4 |__|

Duration of Operation – Minutes |__|__|__| Were perioperative prophylactic antibiotics given?(from skin incision to skin closure) Yes |__| No |__|

Urgent/Elective Operation Urgent |__|

Elective |__|

Page 22: The European protocol for surveillance of surgical site infections Workshop European surveillance of healthcare-associated infections: theory and practice

Surgical Site Infection Surveillance

Operative Procedure Data Collection Form

INFECTION DATA

Surgical Site Infection

Did the patient develop a surgical site infection? Micro-Organism Code #1

No – Stop here |__| |__|__|__|__|__|__|

Yes – Answer remaining questions |__| Resistance Micro-Organism #1 |__|__|

Type of Surgical Site Infection Micro-Organism Code #2

Superficial incisional |__| |__|__|__|__|__|__|

Deep incisional |__| Resistance Micro-Organism #2 |__|__|

Organ/Space |__|

Micro-Organism Code #3

Date of Infection d d / m m / y y y y |__|__|__|__|__|__|

|_______|_______|______________| Resistance Micro-Organism #3 |__|__|

Page 23: The European protocol for surveillance of surgical site infections Workshop European surveillance of healthcare-associated infections: theory and practice

How to measure the occurrence of SSIs?

For each surgical procedure category and for each level

of the NHSN risk indexthree indicators

Cumulative incidence

Cumulative incidence, post-discharge surgical site infections excluded

Incidence density

Page 24: The European protocol for surveillance of surgical site infections Workshop European surveillance of healthcare-associated infections: theory and practice

Cumulative incidence of SSIs (1)

Definitionthe crude percentage of operations resulting in a surgical site

infection

How can be calculated Numerator: number of surgical site infections detected

within 30 days after the operation or 1 year for hip prosthesis and knee prosthesis

Denominator: the total number of operations

Page 25: The European protocol for surveillance of surgical site infections Workshop European surveillance of healthcare-associated infections: theory and practice

Cumulative incidence of SSIs (2)

Example: cholecystectomy 6 months of surveillance 01.01.2008 – 30.06.2008

Number of SSIs detected within 30 days after the operation: 7

Total number of operations: 500

Cumulative incidence: 7 / 500 * 100 = 1.4%

Page 26: The European protocol for surveillance of surgical site infections Workshop European surveillance of healthcare-associated infections: theory and practice

Cumulative incidence of SSIs (3)

Interpretation

This indicator gives the most complete picture for a given surgical

procedure category

but is highly dependent on the length of postoperative stay in

hospital and on the intensity of post-discharge surveillance

Page 27: The European protocol for surveillance of surgical site infections Workshop European surveillance of healthcare-associated infections: theory and practice

Cumulative incidence of SSIs, post-discharge SSIs excluded (1)

Definitionthe crude percentage of operations resulting in a surgical site

infection,before hospital discharge

How can be calculated Numerator: number of surgical site infections detected

before hospital discharge Denominator: the number of operations with known date of

hospital discharge

Page 28: The European protocol for surveillance of surgical site infections Workshop European surveillance of healthcare-associated infections: theory and practice

Example: cholecystectomy 6 months of surveillance 01.01.2008 – 30.06.2008

Number of SSIs detected before hospital discharge: 3Number of operations with known date of hospital discharge:

400

Cumulative incidence of SSIs, post-discharge SSIs

excluded: 3 / 400 * 100 = 0.8%

Cumulative incidence of SSIs, post-discharge SSIs excluded (2)

Page 29: The European protocol for surveillance of surgical site infections Workshop European surveillance of healthcare-associated infections: theory and practice

Interpretation

This indicator only considers surgical site infections detected in the

hospital, therefore is independent of post-discharge surveillance

Anyway it depends on the length of postoperative stay in hospital

Cumulative incidence of SSIs, post-discharge SSIs excluded (3)

Page 30: The European protocol for surveillance of surgical site infections Workshop European surveillance of healthcare-associated infections: theory and practice

Incidence density of SSIs (1)

DefinitionThe rate of surgical site infections detected before hospital

discharge standardized by the length of patient’s postoperative stay in

hospital It can only be calculated when the discharge date is known

How can be calculated Numerator: number of surgical site infections detected before

hospital discharge Denominator: the total number of postoperative patient-days

in hospital (sum of length of postoperative stay in hospital for patients with known date of hospital discharge)

Page 31: The European protocol for surveillance of surgical site infections Workshop European surveillance of healthcare-associated infections: theory and practice

Example: cholecystectomy 6 months of surveillance 01.01.2008 – 30.06.2008

Number of SSIs detected before hospital discharge: 3Total number of postoperative patient-days in hospital:

2,000

Incidence density of SSIs: 3 / 2,000 * 1,000 = 1.5/1,000 patient-

days

Incidence density of SSIs (2)

Page 32: The European protocol for surveillance of surgical site infections Workshop European surveillance of healthcare-associated infections: theory and practice

Interpretation

This indicator only considers surgical site infections detected in the

hospital and therefore it does not reflect the complete epidemiological

picture However, it is independent of post-discharge surveillance and

correctsfor differences in postoperative hospital stay Therefore this indicator may be more reliable for inter-

hospital or inter-network comparisons

Incidence density of SSIs (3)

Page 33: The European protocol for surveillance of surgical site infections Workshop European surveillance of healthcare-associated infections: theory and practice

Conclusions

The European protocol of SSI surveillance is a consolidated tool for SSI surveillance at European level; since the early 2000 it has been used by 14 European countries

It allows to develop a “common methodological language” between different countries and different networks

It contributes to get SSI incidence indicators in order to monitor epidemiological trends and to analyse inter-country and inter-hospital differences

Page 34: The European protocol for surveillance of surgical site infections Workshop European surveillance of healthcare-associated infections: theory and practice

34

Thank you and Good luck

www.ecdc.europa.eu| [email protected]