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Helics icu protocol version 6.


Hospital in Europe
Link for Infection Control through
Surveillance
Surveillance of Nosocomial Infections
in Intensive Care Units
Protocol
(Based on Version 5.0 including technical amendments) Project commissioned by the EC / DG SANCO/ F/ 4
Agreement Reference number: VS/1999/5235 (99CVF4-025) Page 1 of 51 Surveillance of Nosocomial Infections in
Intensive Care Units: Master Protocol
Table of Contents
Page 2 of 51 Main Changes since version 5.0
Version 5.0 of this document was produced in October 2003. Since then a series of technical changes have been applied to this document. Summary of major changes: • Country codes have been updated to include new EU member states as of 2004 • The code for unknown has consistently been set to –1 (used to be 9, 99 etc. in previous versions of this document); to avoid problems for networks using ASCII type data communication internally, the field length of those numeric variables was changed to minimum 2 positions • Structure and text of the chapter on data collection was changed to improve clarity • Duplicate table icu_i were unified (was separate for levels 1 and 2)
• It was made clear that, for the surveillance of infections, a unique Patient ID and Admission data in ICU are mandatory since they are part of the unique key to trace infections. Only the hospital, however, and not the network should be able to trace the individual corresponding to this unique patient ID. • Concatenated ID fields were removed and components mentioned explicitly in tables • The structure o table icu_e was changed to reflect technical considerations of the IT
• The name of table helics_n was changed to icu_net to avoid confusion with similar SSI
• Some variable names and labels were changed to improve consistency • All variable names are consistently in lowercase • Some minor typographical errors were corrected Page 3 of 51 1 Rationale and objectives for surveillance of nosocomial infections
in intensive care units

Surveillance of nosocomial infections in intensive care units was chosen as a Helics component based on the existence of such networks in about half of the EU member states, on the fact that patients admitted to intensive care are at 5 to 10 times higher risk of acquiring a NI due to both intrinsic (e.g. immunodepression) and extrinsic (e.g. mechanical ventilation) risk factors, and because the ICU is often the epicentre of emerging NI problems in the hospital. The main objective of this protocol is to ensure standardisation of definitions, data collection and reporting procedures for hospitals participating in the national/regional surveillance of nosocomial infections (NI) in Intensive Care Units (ICUs) across Europe, in order to contribute to the EU surveillance of nosocomial infections and to improve the quality of care in the ICU in a multicenter setting. Specific objectives are: a At the level of the intensive care unit and the hospital: To monitor the size of the NI problem in a unit and identify the areas where prevention activities are needed, To compare the results of the unit with its previous ones, and for inter-unit comparison, compare groups of patients stratified for infection risk, in order to be able to identify areas where the quality of care can be improved. To sensitize personnel to infection problems (micro-organisms, antibiotic resistance.), set local targets for prevention. To provide relevant information to monitor and target infection control policies: the compliance with existing guidelines and good practices, the correction or improvement of specific practices, the development, implementation and evaluation of new practices. Participation to the European network will also produce gains at local level from international comparisons that may provide insights that would not be revealed by surveillance limited at the regional or national level. b At the level of regional or national network coordination: To provide to the units the necessary reference data to make comparisons of risk- adjusted rates between units/hospitals, To follow-up epidemiological trends in time: Identification of important nosocomial pathogens Epidemiology of emerging infections, antimicrobial resistance To identify and follow-up risk factors of nosocomial infections To improve the quality of data collection Page 4 of 51 c At the EU (HELICS) level To monitor and describe the epidemiology of nosocomial infections in intensive care units in the EU in view of responding to the objectives of Decision 2119/98 EC of the European Parliament and the Council.(1) To identify emerging nosocomial pathogens in the ICU To follow-up the incidence and the geographical spread of nosocomial infections by type and pathogen in the ICU To assess the risk and the occurrence of international spread of nosocomial pathogens To identify regions or countries at higher need of EU support with regard to surveillance and control of nosocomial infections To ensure communication of relevant data on nosocomial infections to the European Commission as a complement to the data transmission by the national Health authorities To facilitate the communication and the exchange of experience between national/regional networks for the surveillance of nosocomial infections To stimulate the creation of national/regional coordination centres for the surveillance of nosocomial infections in the ICU where these centres/networks do not exist To provide methodological and technical support to the national/regional coordination To improve surveillance methodology, data validation and utilization To validate risk factors of nosocomial infections in the ICU at the EU level To explore the correlation between structure and process indicators and the incidence of nosocomial infections in the ICU throughout Europe in order to generate hypotheses and new insights in nosocomial infection control (collaboration Brussels-Berlin). 2 Elaboration of the HELICS protocol for the surveillance of
nosocomial infections in intensive care units

The need for a new standardised protocol for the surveillance of NI in the ICU became apparent from the comparative analysis of the current surveillance methods in the EU during implementation phase 1 of HELICS.(2) The consensus for the new protocol is based on: - an in-depth analysis of the methodology of the existing national/regional surveillance networks for the surveillance of NI in the ICU - a questionnaire sent out to the HELICS-ICU Working Party members designed to measure their opinions about some key issues for the design of a new protocol. - meetings of the HELICS-ICU working party (WP1) - several meetings of the WP1 coordinator with the steering groups or coordinators of different networks in the member states (France, Spain, Germany, The Netherlands, Portugal, Denmark, Belgium, Luxemburg). The final HELICS-ICU protocol integrates as much as possible the conclusions of the different discussions, the results of the questionnaire and the existing national/regional surveillance protocols. The results of the questionnaire and discussions about a new standardised protocol directed towards a combined patient-based (level 2) and less labour-intensive unit-based protocol (level 1). The final HELICS-ICU protocol integrates as much as possible the conclusions of the different discussions, the results of the questionnaire and the analysis of the methods used in the existing national/regional surveillance protocols. Page 5 of 51 3 Indicators to be produced at the European level on the occurrence
and characteristics of nosocomial infections in intensive care units


The indicators generated by the different levels of the ICU-surveillance are shown in figure 1.
Level 1 (unit-based surveillance) represents the minimal data to be collected and is intended for
continuous surveillance. The denominator is collected at the level of the unit and consists in the
number of patient-days for patients staying longer than 2 days in the ICU (unit-based surveillance).
Indicators issued by level 1 are suited for the follow-up of indicators in time within the same unit
and for regional, national and international follow-up of trends for pathogen-specific infection rates.
They offer limited inter-unit comparability but, only when stratified according to the type of unit.

Level 2 is intended for advanced risk-adjusted comparison of infection rates between ICUs
(benchmarking), as a measure of quality of care in terms of infection control. Risk factors are
collected for every patient staying more than 2 days in the ICU, whether infected or not (patient-
based surveillance). In order to obtain sufficient precision of indicators, a surveillance period of 6
months is recommended.
.
A more comprehensive list of indicators generated by the different levels is given in the appendix.

Figure 1. Indicators generated by the different levels of the protocol for the surveillance
of NI infections in the ICU

atient-da s + ICU characteristics + ICU characteristics (NI Risk score, dev Site specific incidence rates Stratification by Page 6 of 51 4 Case definitions of ICU-acquired infections
The minimal requirement for HELICS is to include ICU-acquired bloodstream infection (BSI) or ICU-acquired pneumonia. Other infection types such as urinary tract infections may be added optionally. A specific option is developed under level 2 for the surveillance of catheter infection (surveillance of catheters rather than patients). Definition of key terms: ICU-acquired: an infection is considered as ICU-acquired if it occurs later than 48 hours in the ICU. Second infection episode: The combination of 1) new signs and symptoms and 2) radiographic evidence (for pneumonia) or other diagnostic testing is required. 4.1 Case definition of bloodstream infection

CODE: BSI

BSI-A:
1 positive blood culture for a recognised pathogen Patient has at least one of the following signs or symptoms: fever (>38°C.), chills, or hypotension and 2 positive blood cultures for a common skin contaminant (from 2 separate blood samples drawn within 48 hours).
skin contaminants = coagulase-negative staphylococci, Micrococcus sp., Propionibacterium acnes,
Bacillus sp., Corynebacterium sp.

BSI-B: Patient has at least one of the following signs or symptoms: fever (>38°C.), chills, or
hypotension
And either
1 positive blood culture with a skin contaminant in patient with an intravascular line in place and in whom the physician instituted appropriate antimicrobial therapy. positive blood Antigen test (e.g. H.influenzae, S.pneumoniae, N. meningitidis or Group B Streptococcus)
Comment:
BSI-A is the definition used by the majority of NI surveillance networks in Europe. BSI-B extents
this definition to the CDC definition of laboratory-confirmed bloodstream infection. Networks should
specify in the network data (table icu_net, see 6.3.1) whether only BSI A or both BSI B and BSI A
are included in the surveillance (i.e. networks using CDC definition of laboratory confirmed
bloodstream infection [CDCLCBI=BSI-A+B]). If this is the case, then BSI A and BSI B categories
should be specified in the data collection. Page 7 of 51 4.2 Case definition of ICU-acquired pneumonia
CODE: PN

Two or more serial chest X-rays or CT-scans with a suggestive image of pneumonia for patients with underlying cardiac or pulmonary disease. In patients without underlying cardiac or pulmonary disease one definitive chest X-ray or CT-scan is sufficient. and at least one of the following Fever > 38 °C with no other cause Leukopenia (<4000 WBC/mm3) or leucocytosis (≥ 12 000 WBC/mm3) and at least one of the following (or at least two if clinical pneumonia only = PN 4 and PN 5) New onset of purulent sputum, or change in character of sputum (color, odor, quantity, consistency) Cough or dyspnea or tachypnea Suggestive auscultation (rales or bronchial breath sounds), ronchi, wheezing Worsening gas exchange (e.g., O2 desaturation or increased oxygen requirements or increased ventilation demand) and according to the used diagnostic method a – Bacteriologic diagnostic performed by :
Positive quantitative culture from minimally contaminated LRTimen
Broncho-alveolar lavage (BAL) with a threshold of > 104 CFU≥ 5 % of BAL obtained cells contain intracellular bacteria on direct microscopic exam (classified on the diagnostic category BAL). Protected brush (PB Wimberley) with a threshold of >103 CFU/ml Distal protected aspirate (DPA) with a threshold of > 103 CFU/ml Positive quantitative culture from possibly contaminated LRT specimen Quantitative culture of LRT specimen (e.g. endotracheal aspirate) with a threshold of 106 CFU/ml b – Alternative microbiology methods
Positive blood culture not related to another source of infection Positive growth in culture of pleural fluid Pleural or pulmonary abscess with positive needle aspiration Histologic pulmonary exam shows evidence of pneumonia Positive exams for pneumonia with virus or particular germs (Legionella, Aspergillus, mycobacteria, mycoplasma, Pneumocystis carinii) o Positive detection of viral antigen or antibody from respiratory secretions (e.g., EIA, FAMA, shel vial assay, PCR) o Positive direct exam or positive culture from bronchial secretions or tissue o Seroconversion (ex : influenza viruses, Legionella, Chlamydia) o Detection of antigens in urine (Legionella)
c – Others
Positive sputum culture or non-quantitative LRT specimen culture
No positive microbiology

Note: PN 1 and PN 2 criteria were validated without previous antimicrobial therapy
1 LRT = Lower Respiratory Tract 2 CFU = Colony Forming Units Page 8 of 51 Comment: The subdivision of the pneumonia definition in 5 categories allows for the comparison of similar entities of pneumonia within and between networks. It is essential that all networks report PN4 and PN5 (clinical pneumonia without microbiological evidence) in order to achieve overall comparability, even if a microbiological exam was performed and yielded negative results. It is also advised, both for clinical and surveillance purposes, that networks promote as much as possible microbiological confirmation (PN1-3) as a routine practice in the ICU. Intubation-associated pneumonia (IAP): a pneumonia is defined as intubation-associated (IAP) if an invasive respiratory device was present (even intermittently) in the 48 hours preceding the onset of infection. Note with regard to IAP: It is strongly recommended to report directly the presence of intubation in the 48 hours before the infection. The variable is required in the minimal data set (level 1). Networks deriving this information from daily exposure data should not consider pneumonia in which the intubation was started on the same day as the onset of infection as IAP. Although very early onset IAP may occur rapidly after intubation, in the majority of these cases the ventilation was started because of the increasing ventilation demand of the patient with pneumonia. 4.3 Case definition of CVC-related infection
CODE: CRI
A central venous catheter-related infection relies on:

CRI1: Local CVC-related infection
(no positive blood culture)
quantitative CVC culture ≥ 103 CFU/ml (3) or semi-quantitative CVC culture > 15 CFU (4) pus/inflammation at the insertion site or tunnel
CRI2: General CVC-related infection (no positive blood culture)
quantitative CVC culture ≥ 103 CFU/ml or semi-quantitative CVC culture > 15 CFU clinical signs improve within 48 hours after catheter removal
CRI3: CVC-related BSI
• BSI occurring 48 hours before or after catheter removal and positive culture with the same micro-organism of either: quantitative CVC culture ≥ 103 CFU/ml or semi-quantitative CVC culture > 15 CFU quantitive blood culture ratio CVC blood sample/peripheral blood sample> 5 (5) differential delay of positivity of blood cultures (6): CVC blood sample culture positive 2 hours or less before peripheral blood culture (blood samples drawn at the same time) positive culture with the same micro-organism from pus from insertion site Page 9 of 51 Note: definition of catheter colonisation
CODE: CCO

Surveillance of catheter colonisation can only be done if all hospitals participating to the network
carry out systematic culture of all CVC tips after removal. Catheter colonisation is defined as
follows:
quantitative CVC culture ≥ 103 CFU/ml or semi-quantitative CVC culture > 15 CFU In case of CRI3 only, the three following criteria may also be accepted: positive culture from pus from insertion site quantitive blood culture ratio CVC blood sample/peripheral blood sample> 5 differential delay of positivity of blood cultures: CVC blood sample culture positive 2 hours or less before peripheral blood culture (blood samples drawn at the same time) 4.4 Case definition of urinary tract infection

CODE: UTI

Surveillance of UTI is optional (both in level 1 and level 2). Since the diagnosis of urinary tract
infections in the ICU is complicated by the fact that symptoms are often masked in the comatous
patient, asymptomatic bacteriuria is sometimes included in networks for the surveillance of
nosocomial infections in the ICU. In order to compare similar diagnostic entities between networks,
the UTI should be reported as one of following three categories (UTI-A, B or C):
UTI-A: microbiologically confirmed symptomatic UTI

• Patient has at least one of the following signs of symptoms with no other recognized cause: fever (>38°C), urgency, frequency, dysuria, or suprapubic tenderness • patient has a positive urine culture, that is, ≥ 105 microorganisms per ml of urine with no more than two species of microorganisms.
UTI-B: not microbiologically confirmed symptomatic UTI

• Patient has at least two of the following with no other recognized cause: fever (>38°C), urgency, frequency, dysuria, or suprapubic tenderness and at least one of the following: Positive dipstick for leukocyte esterase and/or nitrate Pyuria urine specimen with ≥10 WBC/ml or ≥ 3 WBC/high-power field of unspun urine Organisms seen on Gram stain of unspun urine At least two urine cultures with repeated isolation of the same uropathogen (gram-negative bacteria or S. saprophyticus) with ≥ 102 colonies/ml urine in nonvoided specimens ≤105 colonies/ml of a single uropathogen (gram-negative bacteria or S. saprophyticus) in a patient being treated with effective antimicrobial agent for a urinary infection Physician diagnosis of a urinary tract infection Physician institutes appropriate therapy for a urinary infection Page 10 of 51 UTI-C: asymptomatic bacteriuria

• Patient has no fever (>38°C), urgency, frequency, dysuria, or suprapubic tenderness and either of the following criteria: 1. Patient has had an indwelling urinary catheter within 7 days before urine is cultured and patient has a urine culture, that is, ≥105 microorganisms per ml of urine with no more than two species of microorganisms. 2. Patient has not had an indwelling urinary catheter within 7 days before the first positive culture and Patient has had at least two positive urine cultures ≥105 microorganisms per mm3 of urine with repeated isolation of the same microorganism and no more than two species of microorganisms. 5 Procedures for participation
5.1 Participation to the HELICS network
The partners of the European network of networks will sign a convention with the HELICS co-
operation. They are expected to report relevant data for at least the minimal data set described in
the current protocol. Only networks coordinated by officially mandated centres should participate.
The institutions in charge of official networks and receiving data from the hospitals must validate
the system and the quality of the data before data are transmitted to the EU database (see below).
Data will not be transmitted directly from the hospitals to the project database (with the exception of
temporary participation of pilot hospitals in the context of creation of a new network). However, if an
official national or regional network exists, individual hospital data from an area covered by such a
network will be refused.
5.2 Minimal participation period
The minimal participation period for participation to the ICU protocol is 3 months. However, in order
to stabilise NI indicators, a minimum period of 6 months is recommended. The simplicity of level 1
encourages a continuous surveillance.
Page 11 of 51 collection
6.1 Population under surveillance
6.1.1 Eligibility criteria for Intensive Care Units
The Intensive Care Units admitted in the surveillance networks must fit the definition established by
the European Society of Intensive Care Medicine (7):
"An ICU is a geographically defined area in the hospital providing care for critically ill patients with
specialised personnel and complex equipment."…
"The ICU is staffed with a specific group of specially trained doctors, nurses and other allied
personnel (e.g. physiotherapists, technicians) in appropriate numbers."…
"The ICU should provide at least facilities for temporary cardiac pacing and invasive
haemodynamic monitoring, ventilation supports and pump-controlled administration of infusions.
Facilities for blood gas, haemoglobin and electrolyte measurements should be provided in the ICU
or in the immediate vicinity. An ICU should function 24 hrs a day, 7 days a week. There must be at
least one doctor immediately available at all times who can deal with all emergencies."…
Neonatal and paediatric ICU can be included in the network, but results should be separately
identified in the analysis.
The aim should be to include as many units as possible. The range of units that are included in the
definition is too wide. Therefore within the very broad group of ICUs, subgroups should be defined
that will allow comparisons (see below). A questionnaire to be filled in by all ICU that take part in
the system will be used to define criteria for the subgroups.
6.1.2 Inclusion of patients
Only patients staying more than two calendar days are included in the surveillance, according to
the following algorithm:
Date of discharge from the ICU – Date of admission to the ICU + 1 > 2
Patients staying less than 3 days in the ICU are excluded. These patients add a lot of patient-days
and also device-days to the denominator, but are not at risk of developing an infection after day 2
in the ICU. Infections appearing after discharge from the ICU (post-discharge) are excluded. Post-
discharge surveillance is time consuming, adds little to the performance of the surveillance system
and is in practice rarely done(8,9).
In level 1 (unit-based surveillance), patient-days are included in the denominator if patients are
present (since more than 2 days) in the time window of the surveillance, even if they were admitted
before the beginning of that period.
In level 2 (patient-based surveillance) patients may be included following two separate methods:
Prospective inclusion: patients are included if the admission date to the ICU falls within the time window of the surveillance. After the end of the surveillance period, patients still under follow-up are censored (arbitrarily discharged) at the last day of the month following the end of the surveillance period (e.g. 31 July if the surveillance is conducted from 1 January to 30 June), in order to allow for data encoding and transmission to the national/regional coordination centre. The follow-up of these patients may be completed and data sent in for correction, e.g. at the end of the following surveillance period. Retrospective inclusion: patients are included if the discharge date from the ICU falls within the time window of the surveillance. Censoring is not an issue in this case and therefore, this method of inclusion is recommended. Note: The different inclusion methods result in slightly different denominator data for the same unit during the same surveillance period. In practice however, these differences are very small. Page 12 of 51 Approximately 2-3% of patients stay longer than 30 days in the ICU and less than 0.05% stay more than 3 months. The difference between unit-based and patient-based denominator data such as patient-days will decrease as the surveillance period increases. 6.2 Type of infections under surveillance
Nosocomial infections occurring after day two and later in the ICU should be reported. Infections
occurring before day 3 may be recorded, but will not be included in the analysis. Data on at least
ICU-acquired bloodstream infection and/or pneumonia should be reported. Other infection types
are optional.
In level 1, only infections occurring within the time window of the surveillance are included.
In level 2, infections may occur outside the time window, since the inclusion criterion is either the
admission or the discharge date of the patient.
6.3 Information to be collected
Variables are classified according to 3 levels:
M=mandatory: data will be rejected if this variable is missing
R=required: these variables are required for the correct interpretation of the results and/or for
routine analysis O=optional, data used for additional analysis
In the tables the first column indicates whether data belong to level 1 and/or level 2 surveillance, or to one of the optional registrations under level 2. The attribute column indicates whether data are mandatory (M), required (R) or optional (O). 6.3.1 Data at the Network level
Information at the level of the regional or national nosocomial infections surveillance network
should be collected once a year.
Data table icu_net: network data table (one record per network per year per surveillance component)
L

Attr. Variable Label
L1,2 M 1Country code L1,2 M 2Network code L1,2 M 3Surveillance component code L1,2 M 4Year net_year L1,2 M 5BSI-A alone or BSI-A+B L1,2 M 6All pneumonia or only IAP 8Other infections 9Catheter infection 10Catheter colonisation L1,2 M 11Level 1 (unit-based surveillance) L1,2 M 12Level 2 (patient-based surveil ance) net_l2 13L2, option a (NI risk score) 14L2, option b (CVC surveillance) 15L2, option c (antimicrobial use) Unique key=country code + network code + surveillance component code + year 1. Country code: country codes based on EARSS protocol (EARSS manual 2004,
es (International Organization for Standardization ISO 3166-1-alpha-2-code elements); AT=Austria; BE=Belgium; BG=Bulgaria; HR=Croatia; CY=Cyprus; CZ=Czech Republic; DK=Denmark; EE=Estonia; FI=Finland; FR=France; DE=Germany; GR=Greece; HU=Hungary; IS=Iceland; IE=Ireland; IL=Israel; IT=Italy; LV=Latvia; LT=Lithuania; LU=Luxembourg; MT=Malta; NL=Netherlands; NO=Norway; PL=Poland; PT=Portugal; RO=Romania; RU=Russian Federation; SK=Slovakia; SI=Slovenia; ES=Spain; SE=Sweden; CH=Switzerland; UK=United Kingdom Page 13 of 51 2. Network code: internal code given by the national coordinator to each sub-network in the
country, e.g. different C.Clin networks in France; 00 if not applicable; EN,SC,WA,NI designate England, Scotland, Wales and Northern-Ireland 3. Surveillance component code: always 1 for ICU surveillance (2=SSI surveillance)
4. Year: year for which data apply (yyyy)
Infections included in the national/regional surveillance network
These data are required for the interpretation of data coming from the different networks: e.g. zero rates
for a given (sub-)type of infections due to the fact that the national/regional protocol does not include that
type of infections.
5. BSI: 0=not included in the protocol, 1=Inclusion of BSI-A alone or 2=BSI-A+BSI-B
6. Pneumonia: 0:not included, 1=intubator-associated pneumonia only or 2=all Pneumonia
urinary tract infections 0=not included in the protocol: 1=UTI-A+UTI-B+UTI-C; 2=UTI-
A+UTI-B (=CDC); 3=UTI-A+UTI-C; 4=UTI-A only 8. Inclusion of the category "other infections"; 1=yes; 0=no
9. Inclusion of central catheter related infections (CRI) 1=yes; 0=no
10. Inclusion of central catheter colonization (CCO) 1=yes; 0=no
Note: systematic culture of all central catheters at removal in all hospitals participating to the network is
required for the inclusion of central catheter colonization

Mode of surveillance
11. Level 1: minimal data (unit-based): 1=yes; 0=no
12. Level 2: basic patient-based level: 1=yes; 0=no
Note: level 1 and level 2 surveillance may be implemented simultaneously in the same network
Options for L2:
13. Option a: standardised infection ratio for PN/BSI (see 6.3.4 and 6.3.6.5): 1=yes; 0=no 14. Option b: surveillance of central venous catheters + standardised infection ratio for CVC-related infection (see 6.3.4 and 6.3.6.6): 1=yes; 0=no 15. Option c: antimicrobial use in the ICU (see 6.3.4 and 6.3.6.7): 1=yes; 0=no Note: if only some participating hospitals choose L2 or L2 + one of the options, mark "yes" 6.3.2 Data at the Hospital and unit level
Data at the level of the hospital and the intensive care unit should be collected once a year. These
data will be used to stratify infection rates (by e.g. type of ICU) to improve comparibility.
For each hospital, collect:
Data table icu_h: Hospital characteristics data table (one record per hospital and per year)
L

Attr. Variable Label
L1,2 M 1 Country code country_id text 2 L1,2 M 2 Network code L1,2 M 3 Surveillance component code L1,2 M 4 Year net_year L1,2 M 5 Hospital code 6 Hospital size (n of beds in categories) 8 Hospital location unique key=country code + network code + surveillance component code + year + hospital code
For each separate Intensive Care Unit, collect:
Data table icu_u: ICU characteristics data table (one record per ICU and per year)
L

Attr. Variable Label
L1,2 M 1 Country code L1,2 M 2 Network code L1,2 M 3 Surveillance component code L1,2 M 4 Year net_year Page 14 of 51 L1,2 M 5 Hospital code L1,2 M 9 ICU code 12 ICU, % of intubated patients over last year unique key=country code + network code + surveillance component code + year + hospital code + ICU code
1. Country code: see 6.3.1
2. Network code: see 6.3.1
3. Surveillance component code: see 6.3.1 (1 for ICU)
4. Year: year for which data apply
5. Hospital
hospital codes should be anonymized at the level of the surveillance network. Hospital names or codes used within a network should be converted to a new numeric code before sending data to Helics and the resulting code table (mapping of usual hospital ID's to new Helics code) should be available at the level of the surveillance network only. 6. Hospital size (n beds in categories): 0=0-99, 1=100-199, 2=200-299, 3=300-399, 4=400-499,5=500-
599,…,-1= unknown 7. Hospital type: 1=University hospital, 2=general hospital, teaching; 3=general hospital, non-teaching;
4=specialist or other hospital; -1= unknown 8. Hospital location/region: optional; region within a country where hospital is located; geographical
code defined by the national coordination and used for mapping at EU level (e.g. pathogen-specific infection rates); may coincide with Network code; 00 if not applicable unique code for ICU, should remain identical in different surveillance periods/ years; ICUs from the same hospital should have different codes 10. ICU size: number of beds in the ICU
11. ICU type: 1=mixed, 2=medical, 3=surgical, 4=Coronary Care Unit, 5=burns, 6=neurosurgical;
7=pediatric, 8=neonatal; 9=other; -1= unknown: if 80% of the patients belong to a particular category, the ICU falls within that category 12. Percentage intubated patients over last year in the ICU: measured or estimated percentage of
patients with an invasive respiratory device over the last year These hospital and ICU characteristics represent the minimal data set that will be used for stratification of reference data. A more comprehensive questionnaire about relevant structural and process indicators is developed elsewhere. 6.3.3 Level 1 surveillance (unit-based surveillance)
Level 1 represents the minimal data to be collected by every surveillance network and is suited for
continuous surveillance because of its limited workload. Since the patient case mix of a single ICU
usually remains quite stable over time, it can be used to follow-up trends of infection rates in the
same unit. Most variations in risk-adjusted rates (e.g. n of intubator-associated pneumonia/1000
intubation days) are paralleled by variations in incidence densities (e.g. n of pneumonia/1000
patient-days). However, although level 1 surveillance offers limited inter-ICU comparison
possibilities (e.g. pathogen-specific infection rates), level 2 is more suited for benchmarking (e.g.
on a temporary basis combined with level 1).
For level 1 surveillance, denominator data should be collected at least every 3 months but
preferably by month, using table icu_d (denominator data: one record per ICU and per surveillance
period). For each infection episode with onset (infection date) within the start and end date of the
surveillance period, a record should be entered in table icu_i (infection data: one record per
infection episode and per infection site).
6.3.4 Level 2 surveillance (patient-based surveillance)
In level 2, patient data and exposure data are collected for each patient staying longer than 2 days
in the ICU. This patient-based surveillance collects both intrinsic and extrinsic risk factors and
allows for stratification of nosocomial infection rates, e.g. device-adjusted infection rates by patient
type. Level 2 without options represents the basic (minimal) patient data set.
Page 15 of 51 For level 2 without further options tables icu_p (one record per patient and ICU admission), icu_i
(infection data: one record per infection episode and per infection site) and icu_e (day by day
exposure: one record per patient-day and per device-exposure during that day) are required.
Three optional modules can be combined with level 2.
Option a: standardized infection ratio (SIR) for pneumonia and BSI.(10)
Option b: SIR for catheter-related infections, based on risk factors by catheter.(11)
Option c: fol ow-up of antimicrobial use in the ICU.

For option a additional variables (indicated as Oa) should be recorded in tables icu_p and icu_e.
For option b table icu_c should be completed (one record per central venous catheter and per
patient-ICU admission.
For option c table icu_a should be completed (one record per infection episode and per infection
site)
6.3.5 Optional antimicrobial resistance data (level 1 or level 2)
Instead of using the predefined list of antimicrobial resistance "tracer" phenotypes as available in
table icu_i, networks may prefer to use complete or partial antibiogram data. In this case, instead
of
table icu_i, two separate tables should be transferred, one table with a unique record per
infection (table icu_inf) and a second table with a unique record for each micro-organism (table
icu_res).
6.3.6 Detailed description of patient data tables

6.3.6.1 Denominator data: table icu_d (level 1 only)
Denominator data should be collected at least every 3 months but preferably by month.
Data table icu_d: Level 1 denominator data (one record per ICU and per surveillance period)
L

Attr. Variable Label
L1 M 1 Country code country_id text 2 L1 M 2 Network code L1 M 3 Surveillance component code L1 M 4 Hospital code L1 M 6 Start date surveillance period L1 M 7 End date surveillance period 8 Number of new admissions staying more 9 Number of patient-days for patients staying more than 2 days in the ICU L1 O 10 Number of new admissions in the ICU, all adi_al number L1 O 11 Number of patient-days in the ICU, all unique key= country code + network code + surveillance component code + hospital code + ICU code + start
date + end date
1. Country code: see 6.3.1
2. Network code: see 6.3.1
3. Surveillance component code: see 6.3.1 (1 for ICU)
4. Hospital
5. ICU code: see 6.3.2
6. Start date surveillance period (dd/mm/yyyy): e.g.1/1/2004
7. End date surveillance period (dd/mm/yyyy): e.g. 31/1/2004 or 31/3/2004; data by month or by 3
8. Number of new admissions in the ICU staying more than 2 days: number of patients for whom
the admission date to the ICU falls within the surveillance period and for whom the length of stay is longer than 2 calendar days (discharge date-admission date+1>2) Page 16 of 51 9. Number of patient-days for patients staying more than 2 days in the ICU: number of patient-days
within the surveillance period from patients staying more than 2 calendar days (discharge date-admission date+1>2), possibly admitted before the surveillance period, see appendix 10. Number of new admissions in the ICU, all: number of patients for whom the admission date to the
ICU falls within the surveillance period 11. Number of patient-days, all: number of patient-days within the surveillance period
Notes:
The collection of al ICU admissions is done as an indicator of the workload represented by patients with a short ICU stay (1 or 2 days) Since the primary objective of level 1 surveillance is the follow-up of trends, it is preferred to collect denominator data (patients and patient-days) by month The collection of unit-based denominator data should, as much as possible, be computerized, based on a list (e.g. administrative database) of ICU patients with admission date to the ICU and discharge date from the ICU. An example of an algorithm to compute the denominator data from such a database is given in the appendix. 6.3.6.2 Infection data: table icu_i (level 1 or level 2)
For each infection episode with onset (infection date) within the start and end date of the
surveillance period, following variables should be collected.
Data table icu_i: Level 1 numerator (infection) data (one record per infection episode and per
infection site)

Attr. Variable Label
L1,2 M 1 Country code country_id text 2 L1,2 M 2 Network code L1,2 M 3 Surveillance component code L1,2 M 4 Hospital code L1,2 M 5 ICU code L1,2 M 6 Patient ID L1,2 M 7 Date ICU admission L1,2 M 8 Infection date L1,2 M 9 Infection site (categories) 10 Micro-organism 1 L1,2 R/O 11 Resistance micro-organism 1 12 Micro-organism 2 L1,2 R/O 13 Resistance micro-organism 2 14 Micro-organism 3 15 Resistance micro-organism 3 16 Invasive device in 48 hours preceding 17 Origin of bloodstream infection 18 Antimicrobial treatment 19 Validated infection L2 O 20 CVC number unique key = country code + network code + surveillance component code + hospital code + ICU code +
patient ID + date ICU admission + infection date + infection site
1. Country code: see 6.3.1
2. Network code: see 6.3.1
3. Surveillance component code: see 6.3.1 (1 for ICU)
4. Hospital
5. ICU code : see 6.3.2
6. Patient ID unique patient code. This code should be anonymous and prevent the network
coordination from tracing back the patient. However, a patient that is infected or admitted several times to the ICU should keep the same number. Since this number will also be used for validation studies, (only) the hospital should be able to link the number to the patient's file. 7. Date ICU admission (dd/mm/yyyy): date of admission in the ICU.
Page 17 of 51 8. Infection
(dd/mm/yyyy): date onset infection (date all necessary case definition criteria are met, date of sample if appropriate); include all infections occurring after day 2 in the ICU for which the infection date falls within the surveillance period; infections occurring on day 1 and day 2 may be reported but will not be included in the indicators. 9. Infection site (also see case definitions): PN1-5, BSI-A/B, UTIA-C, CRI1-3, CCO, OTH
Pneumonia : always specify subcategory ! PN1: protected sample + quantitative culture (104 CFU/ml BAL/103 PB,DPA) PN2: non-protected sample (ETA) + quantitative culture (106 CFU/ml) PN3: alternative microbiological criteria PN4: sputum bacteriology or non-quantitative ETA PN5: no microbiological criterion (only clinical criteria, see case definition) BSI: Bloodstream infection BSI-A: positive hemoculture recognized pathogen/ 2 HC+ skin contaminant BSI-B: CDC extension (see case definition) - optional UTI: Urinary tract infection (optional) UTI-A: microbiological y confirmed symptomatic UTI UTI-B: symptomatic UTI, not microbiologically confirmed UTI-C: asymptomatic bateriuria CRI: CVC-related infection (optional) CRI1: local catheter infection CRI2: generalized catheter infection CRI3: CVC-related bloodstream infection CCO: CVC colonization (optional) OTH: other ICU-acquired infection (optional) 10. Micro-organism1: Required. 6 character code list (WHOCARE-based) – see code list in appendix; if
no micro-organism is available, specify either _NONID (Micro-organism not identified or not found), _NOEXA(examination not done) or _STERI (Sterile examination). 11. Antimicrobial resistance1: 1 digit (see code list in appendix)
required: oxacillin resistance in S. aureus (0=MSSA 1=MRSA -1= unknown) other micro-organisms: optional 12. Micro-organism2: Required
13. Antimicrobial resistance2: Required for S.aureus , optional for other micro-organisms
14. Micro-organism3: Optional
15. Antimicrobial resistance3: Required for S.aureus , optional for other micro-organisms
16. Invasive device in 48 hours preceding the infection: Mandatory for pneumonia (to distinguish
device-associated pneumonia from other pneumonia), optional (but recommended) for bloodstream infection (presence of central venous catheter) and UTI (presence of urinary catheter). 0=no 1=yes - -1= unknown (unknown not allowed if infection site=PN) 17. Origin of bloodstream infection (optional): C (C-CVC,C-PER,C-ART), S (S-PUL, S-UTI, S-DIG, S-
SSI, S-SST, S-OTH), U Catheter (C): the same micro-organism was cultured from the catheter or symptoms improve within 48
hours after removal of the catheter (C-CVC: central venous catheter, C-PER: peripheral catheter, C-ART: arterial catheter) Secondary to another site (S): the same micro-organism was isolated from another infection site or
strong clinical evidence exists that bloodstream infection was secondary to another infection site, invasive diagnostic procedure or foreign body. o Pulmonary (S-PUL) o Urinary tract infection (S-UTI) o Digestive tract infection (S-DIG) o SSI (S-SSI): surgical site infection o Skin and soft tissue (S-SST) o Other (S-OTH) Unknown (U): None of the above, bloodstream infection of unknown origin
18. Antimicrobial treatment (optional): patient received antimicrobial treatment for this infection (incl.
antiviral and antifungal treatment); 0=no 1=yes -1= unknown 19. Validated infection (optional): e.g. for use in electronic surveillance, detected "infections" on the
basis of positive microbiological result and/or antimicrobial treatment should be validated by the clinician (confirm that the infection matches the case definition) 0=no 1=yes 9=not applicable -1= unknown 20. CVC number (optional): links infection record to a specific central venous catheter in level 2 option b
(CVC-based surveillance), see table icu_c
Page 18 of 51 6.3.6.3 Level 2 patient data: table icu_p
In level 2, patient data and exposure data are collected for each patient staying longer than 2 days
in the ICU.
In the following tables, data are classified according to the data structure. The first column indicates
whether data belong to basic level 2 surveillance or to one of the optional modules.
Data table icu_p: Level 2 patient data (one record per patient and ICU admission)
L

Attr. Variable Label
L2 M 1 Country code country_id text 2 L2 M 1 Network code L2 M 1 Surveillance component code L2 M 2 Hospital code L2 M 4 Patient ID L2 M 5 Date ICU admission L2 M 6 Discharge date from the ICU L2 R 7 Discharge status L2 R 8 Gender sex L2 O 10 Patient origin L2 R 11 Admission date in the hospital L2 R 12 SAPS II score L2 O 13 APACHE II score L2 R 14 Type of admission L2 O 16 Impaired immunity L2 R 17 Antimicrobial treatment within 48 h around admission (<>48h) Oa R 18 Acute coronary care 19 Surgery in 30 days before admission (2 variables for 2 possible sites) Oa O 20 Glasgow coma score, estimated Oa O 21 Glasgow coma score, measured unique key = country code + network code + surveillance component code + hospital code + ICU code +
patient ID + date ICU admission
1. Country code, network code, surveillance component code: link with network data table, see
2. Hospital
code: see 6.3.2
3. ICU code: see 6.3.2
4. Patient
ID: unique patient code. This code should be anonymous and prevent the network
coordination from tracing back the patient. However, a patient that is infected or admitted several times to the ICU should keep the same number. Since this number will also be used for validation studies, (only) the hospital should be able to link the number to the patient's file. 5. Date ICU admission (dd/mm/yyyy): date of admission in the ICU
6. Date ICU discharge (dd/mm/yyyy): date of discharge from the ICU - it is recommended to include
patients based on this date, e.g. when participating to the surveillance from 1/4/2002 to 30/4/2002, include al patients that are discharged in this period and where (date of discharge - date of admission + 1) > 2 (=patients staying more than 2 calendar days in the ICU); patients may also be included prospectively based on admission date (see higher) 7. Discharge status (number 1): status at discharge from ICU (1 = discharged alive from ICU, 2 =
death in ICU, -1 = unknown); record date of death as date of discharge from ICU; (Note:DNR/withdrawal may be added as supplementary category- discharged alive with therapeutic withdrawal - DNR=do not resuscitate) 8. Gender (string 1): gender of the patient (M/F/U)
9. Age (numeric 3): age in years, -1= unknown
10. Patient origin: 1=ward in this/other hospital; 2=other ICU; 3=community (patient came from his
home, via emergency or not); 4=long term care/nursing home; -1= unknown 11. Admission date in hospital (dd/mm/yyyy): date of admission in the hospital
Page 19 of 51 12. SAPS II score on admission (numeric 3): Simplified Acute Physiology Score (12) at admission -
Severity of illness score developed to predict mortality (see appendix); SAPS II score is preferred because it was validated in the nosocomial infection risk score; -1= unknown; if not available, use 13. APACHE II score on admission (numeric 3): Acute Physiology, Age, Chronic Health Evaluation score
(13) - see appendix 1; -1= unknown; prefer SAPS II score because of use in NI risk score. Also see appendices for details on risk scores. 14. Type of admission (numeric 1): as defined in SAPS II score (1=medical: no surgery within 1 week of
admission to ICU; 2=scheduled surgical: surgery was scheduled at least 24 hours in advance +/- 7 days ICU admission; 3=unscheduled surgical: patients added to the operating room schedule within 24 hours of the operation); -1 = unknown 15. Trauma: ICU admission resulted from blunt or penetrating traumatic injury to the patient, with or
without surgical intervention; 1=yes; 0=no; -1= unknown 16. Impaired immunity: 1=yes; 0=no; -1= unknown; yes: <500 PMN/mm3, due to treatment
(chemotherapy, radiotherapy, immune suppression, corticosteroids long duration or high doses recently), due to disease (leucemia, lymphoma, AIDS) - Apache II definition 17. Antimicrobial therapy around admission: 1=yes; 0=no; -1= unknown; specify "yes" if any antibiotic
therapy in the 48 hours preceding ICU admission and/or during the first 2 days of ICU stay (=antibiotic therapy for an infectious event around ICU admission, excl. antifungal and antiviral treatment) has been given; not: antimicrobial prophylaxis, SDD, local treatment 18. Acute coronary care : All acute non-surgical cardiac disease. Larger than coronary suffering;
1=yes; 0=no; -1 = unknown 19. Surgery before admission + site: specify whether patient had surgery in the last 30 days before
ICU admission including the day of admission, and if so, specify the surgery site; codes: 0=no surgery;1=coronary surgery; 2=other cardiac; 3=other thoracic; 4=other vascular; 5= neurosurgery; 6=other surgery; -1= unknown 20. Glasgow Coma score, estimated (numeric 2): Use the lowest value in first 24 hours; -1= unknown;
record both a. the "original"=estimated GCS, i.e. if the patient is sedated, record the estimated Glasgow Coma Score before sedation (see appendix 1) (=component of both SAPS II and APACHE II score) and, 21. Glasgow Coma score, measured (numeric 2): the "measured" GCS, i.e. if the patient is sedated,
record measured status at that moment; see appendix for details on GCS; -1= unknown 6.3.6.4 Level 2 day by day exposure data: table icu_e
Data table icu_e: Level 2 day-by-day exposure data (one record per day and per patient-device-
exposure during that day)
L

Attr. Variable Label
country_id text 2 1 Surveillance component code 5 Date ICU admission L2/Oa R/O 7 ICU Exposure unique key = country code + network code + surveillance component code + hospital code + ICU code +
patient ID + date ICD admission + date in ICU
1. Country code, network code, surveillance component code: link with network data table, see
2. Hospital
code: see 6.3.2
3. ICU code: see 6.3.2
4. Patient
ID: unique patient code. This code should be anonymous and prevent the network
coordination from tracing back the patient. However, a patient that is infected or admitted several times to the ICU should keep the same number. Since this number will also be used for validation studies, (only) the hospital should be able to link the number to the patient's file. 5. Date ICU admission (dd/mm/yyyy): date of admission in the ICU
6. Date in the ICU: day in the ICU for which daily exposure data are recorded
Page 20 of 51 7. ICU Exposure: Required for Level 2: CVC and INT; Optional for Level 2: UC; Required for option a:
NIT, FNIT, PN; Optional for option a: NIV, VEN, REINT. CVC=Central venous catheters: specify
whether >=1 CVC was present in this patient on that day; CVC = vascular access device that
terminates at or close to the heart or one of the great vessels; excluded: arterial catheters, external
pacemaker, implanted chambers; included: v. subclavia, v. jugularis, v. basilica, v. cephalica, v.
femoralis, v.umbilicalis, other veins, dialysis catheters, Swann-Ganz; optionally fill out one record by
catheter (option b); INT=Intubation: patient has oro-tracheal or naso-tracheal intubation or
tracheotomy , even if intermittent during the day (1 hour is counted as 1 day); UC=Urinary catheter:
urinary catheter use; suprapubic catheters are included; iterative urinary catheterization excluded
(e.g. for urinary sampling or in case of urine retention); optional, if UTI are registered; NIT=Naso-oro
intestinal tube without feeding in ICU
: specify whether patient had a naso-oro intestinal tube
without feeding in the ICU; FNIT=Naso-oro intestinal tube with feeding in ICU: specify whether
patient had a naso-oro intestinal tube with feeding in the ICU; PN=Parenteral nutrition in ICU:
specify whether patient had parenteral nutrition in the ICU =patient receives minimum 2 nutritional
elements via perfusion (2 out of 3: proteins, fats and sugars); NIV=Non-invasive mechanical
ventilation
: patient is ventilated (any form of mechanical respiratory assistance of inspiration and/or
expiration) without intubation (BIPAP/CIPAP); VEN=Invasive mechanical ventilation: patient is
ventilated (any form of mechanical respiratory assistance of inspiration and/or expiration) with
intubation; REINT=Re-intubation: patient was extubated and re-intubated on that day (at least once)
6.3.6.5 Level 2 option a: PN/BSI risk score
Additional variables in tables icu_p and icu_e (see related description) need to be recorded to
compute the risk scores for pneumonia and bloodstream infections originally developed by the
NSIH surveil ance network in Belgium (10). Optional variables were added on suggestion of the
ICU working party and members of the infection section of ESICM in order to validate and possibly
customize the risk score at the European level.
6.3.6.6 Level 2 option b: risk score for catheter-related infection: table icu_c
This option includes variables to be recorded for each central venous catheter (CVC) to allow the
calculation of the standardized catheter-infection ratio developed by the REACAT surveillance
network (C.Clin Paris-Nord, France) as an indicator of quality of catheter care.(11)
Data table icu_c: Level 2 Option b: central venous catheter (CVC) data (one record per CVC and per
patient-ICU admission)
L

Attr. Variable Label
Ob M 1 Country code country_id text 2 Ob M 1 Network code Ob M 1 Surveillance component code Ob M 2 Hospital code Ob M 4 Patient ID Ob M 5 Date ICU admission Ob M 6 CVC number Ob R 7 Date insertion CVC Ob R 8 Insertion site CVC Ob R 9 Antibiotic perfusion through catheter Ob R 10 Date CVC removal Ob R 11 Other infection at removal 12 At least 1 organ failure at removal unique key = country code + network code + surveillance component code + hospital code + ICU code +
patient ID+ date ICU admission + CVC number
1. Country code, network code, surveillance component code: link with network data table, see
2. Hospital
code: see 6.3.2
3. ICU code: see 6.3.2
Page 21 of 51 4. Patient
ID: unique patient code. This code should be anonymous and prevent the network
coordination from tracing back the patient. However, a patient that is infected or admitted several times to the ICU should keep the same number. Since this number will also be used for validation studies, (only) the hospital should be able to link the number to the patient's file. 5. Date ICU admission (dd/mm/yyyy): date of admission in the ICU
6. CVC number: ID number for this central venous catheter (link with infection data: table icu_i)
7. Insertion date: date CVC was inserted
8. Site: catheter insertion site; 1=subclavia, 2=jugular, 3=femoral, 4=other site; -1= unknown
9. ATB perfusion: antibiotic perfusion given via CVC; 1=yes; 0=no; -1= unknown
10. Date removal: date CVC was removed
11. Other infection at removal: did the patient have an infection at any other site at the moment of CVC
removal? 1=yes; 0=no; -1= unknown 12. At least 1 organ failure at removal: did the patient have an organ failure (at least one) at the
moment of CVC removal? 1=yes; 0=no; -1= unknown 6.3.6.7 Level 2 option c: antimicrobial use: icu_a
Data table icu_a: Level 2, Option c: antimicrobial use data (one record per antimicrobial class per day
and per patient-ICU admission)
L

Attr. Variable Label
Oc M 1 Country code country_id text 2 Oc M 1 Network code Oc M 1 Surveillance component code Oc M 2 Hospital code Oc M 4 Patient ID Oc M 5 Date ICU admission Oc R 7 Antimicrobial ATC-code Oc R 8 Reason for antimicrobial use unique key= country code + network code + surveillance component code + hospital code + ICU code +
patient ID+ date ICU admission + date in ICU + antimicrobial class
1. Country code, network code, surveillance component code: link with network data table, see
2. Hospital
code: see 6.3.2
3. ICU code: see 6.3.2
4. Patient
ID: unique patient code. This code should be anonymous and prevent the network
coordination from tracing back the patient. However, a patient that is infected or admitted several times to the ICU should keep the same number. Since this number will also be used for validation studies, (only) the hospital should be able to link the number to the patient's file. 5. Date ICU admission (dd/mm/yyyy): date of admission in the ICU
6. Date in the ICU: day in the ICU for which daily exposure data are recorded
7. Antimicrobial molecule (ATC code): 41: antimicrobial ATC code list in appendix, ordered by
antimicrobial class e.g. J01CE= Beta-lactamase sensitive penicillins; ATC-code J01CE01=Benzylpenicillin 8. Reason for antimicrobial use: S: SDD (selective digestive decontamination), P:prophylaxis (ex.
surgical); E: empiric therapy - antimicrobial treatment of an infection (or suspicion of infection) without microbiological proof, M: gram-stain or micro-organism known, A: antibiogram known 6.3.6.8 Optional antimicrobial resistance data tables (level 1 or level 2)
Instead of using a predefined list of antimicrobial resistance "tracer" phenotypes, networks may
prefer to use complete or partial antibiogram data. In this case, two separate tables should be
transferred, one with a unique record per infection (icu_inf) and a second table with a unique
record for each micro-organism (icu_res).
Data table icu_inf: Infection data (one record per infection episode and per infection site)
L Attr.

Variable
Variable Format Length
L1,2 M 1 Country code country_id text 2 L1,2 M 1 Network code Page 22 of 51 L1,2 M 1 Surveillance component code L1,2 M 2 Hospital code L1,2 M 3 ICU code L1,2 M 4 Patient ID L1,2 R 5 Date ICU admission addt_icu date 10 L1,2 M 6 Infection date L1,2 M 7 Infection site (categories) L1,2 R 8 Invasive device in 48 hours preceding inv_dev number 2 L1,2 O 9 Origin of bloodstream infection L1,2 O 10 Antimicrobial treatment L1,2 O 11 Validated infection L1,2 O 12 CVC number cvc_num number 2 unique key = country code + network code + surveillance component code + hospital code + ICU code +
patient ID + infection date + infection site
1. Country code, network code, surveillance component code: link with network data table, see
2. Hospital
code: see 6.3.2
3. ICU code: see 6.3.2
4. Patient
ID: unique patient code. This code should be anonymous and prevent the network
coordination from tracing back the patient. However, a patient that is infected or admitted several times to the ICU should keep the same number. Since this number will also be used for validation studies, (only) the hospital should be able to link the number to the patient's file. 5. Date ICU admission (dd/mm/yyyy): date of admission in the ICU
6. Infection
(dd/mm/yyyy): date onset infection (date all necessary case definition criteria are met, date of sample if appropriate); include all infections occurring after day 2 in the ICU for which the infection date falls within the surveillance period; infections occurring on day 1 and day 2 may be reported but will not be included in the indicators. 7. Infection site (also see case definitions): PN1-5, BSI-A/B, UTIA-C, CRI1-3, CCO, OTH
Pneumonia : always specify subcategory ! PN1: protected sample + quantitative culture (104 CFU/ml BAL/103 PB,DPA) PN2: non-protected sample (ETA) + quantitative culture (106 CFU/ml) PN3: alternative microbiological criteria PN4: sputum bacteriology or non-quantitative ETA PN5: no microbiological criterion (only clinical criteria, see case definition) BSI: Bloodstream infection BSI-A: positive hemoculture recognized pathogen/ 2 HC+ skin contaminant BSI-B: CDC extension (see case definition) - optional UTI: Urinary tract infection (optional) UTI-A: microbiological y confirmed symptomatic UTI UTI-B: symptomatic UTI, not microbiologically confirmed UTI-C: asymptomatic bateriuria CRI: CVC-related infection (optional) CRI1: local catheter infection CRI2: generalized catheter infection CRI3: CVC-related bloodstream infection CCO: CVC colonization (optional) OTH: other ICU-acquired infection (optional) 8. Invasive device in 48 hours preceding the infection: Mandatory for pneumonia (to distinguish
device-associated pneumonia from other pneumonia), optional (but recommended) for bloodstream infection (presence of central venous catheter) and UTI (presence of urinary catheter). 0=no 1=yes - -1= unknown (unknown not allowed if infection site=PN) 9. Origin of bloodstream infection (optional): C (C-CVC,C-PER,C-ART), S (S-PUL, S-UTI, S-DIG, S-
SSI, S-SST, S-OTH), U Catheter (C): the same micro-organism was cultured from the catheter or symptoms improve within 48
hours after removal of the catheter (C-CVC: central venous catheter, C-PER: peripheral catheter, C-ART: arterial catheter) Secondary to another site (S): the same micro-organism was isolated from another infection site or
strong clinical evidence exists that bloodstream infection was secondary to another infection site, invasive diagnostic procedure or foreign body. Page 23 of 51 o Pulmonary (S-PUL) o Urinary tract infection (S-UTI) o Digestive tract infection (S-DIG) o SSI (S-SSI): surgical site infection o Skin and soft tissue (S-SST) o Other (S-OTH) Unknown (U): None of the above, bloodstream infection of unknown origin
10. Antimicrobial treatment (optional): patient received antimicrobial treatment for this infection (incl.
antiviral and antifungal treatment); 0=no 1=yes -1= unknown 11. Validated infection (optional): e.g. for use in electronic surveillance, detected "infections" on the
basis of positive microbiological result and/or antimicrobial treatment should be validated by the clinician (confirm that the infection matches the case definition) 0=no 1=yes 9=not applicable -1= unknown 12. CVC number (optional): links infection record to a specific central venous catheter in level 2 option b
(CVC-based surveillance), see table icu_c

Data table icu_res: Micro-organism & antimicrobial resistance data (one record per micro-organism)

L Attr.
Variable
Variable Format Length
L1,2 M 1 Country code country_id text 2 L1,2 M 1 Network code L1,2 M 1 Surveillance component code L1,2 M 2 Hospital code L1,2 M 3 ICU code L1,2 M 4 Patient ID L1,2 R 5 Date ICU admission addt_icu date 10 L1,2 M 6 Infection date L1,2 M 7 Infection site (categories) L1,2 M 8 Micro-organism L1,2 O 9 Penicillin susceptibility L1,2 O 10 Ampicil in r_ampi L1,2 O 11 Amoxicil in/clavulanate r_aug L1,2 R 12 Methicillin/oxacillin (beta-lact.res.penic.) L1,2 O 13 Piperacillin/ticarcillin (anti-pseudom. penic.) L1,2 O 14 Piperacillin/ticarcillin + enzyme inhibitor r_pipenz text L1,2 O 15 Cefalotin/cefazolin (1st gen cephalosporins) L1,2 O 16 Cefuroxim/cefamandole/cefoxitin (2G ceph) L1,2 O 17 Cefotaxime/ceftriaxone (3rd gen ceph.) L1,2 O 18 Ceftazidim (anti-pseudom 3G ceph) L1,2 O 19 Cefepime/cefpirome (4G cephalosporin) L1,2 O 20 Extended Spectrum Beta-Lactamase (ESBL) r_esbl text L1,2 O 21 Meropenem/imipenem (carbapenems) L1,2 O 22 Co-trimoxazole (sulfamethoxazole + trimet.) L1,2 O 23 Tetra-/doxy-/minocycline (tetracyclines) L1,2 O 24 Erythromycin (macrolides) L1,2 O 25 Clindamycin (lincosamides) L1,2 O 26 Quinupristin/dalfopristin (streptogramins) L1,2 O 27 Gentamycin r_genta L1,2 O 28 Netilmycin r_netil L1,2 O 29 Tobramycin r_tobra L1,2 O 30 Amikacin r_amika L1,2 O 31 Ciprofloxacin/oflocacin r_cipro L1,2 O 32 Levofloxacin r_levo L1,2 O 33 Gatifloxacin/Sparfloxacin r_gatiflo L1,2 O 34 Moxifloxacin/Trovafloxacin r_moxiflo L1,2 O 35 Nalidixic acid L1,2 O 36 Vancomycin/teicoplanin (Glycopeptides) L1,2 O 37 Colistin (polymixins) L1,2 O 38 Fusidic acid L1,2 O 39 Fosfomycin r_fosfomy L1,2 O 40 Linezolid r_linezo L1,2 O 41 Ketoconazol r_keto Page 24 of 51 L1,2 O 42 Fluconazole r_fluco L1,2 O 43 Itraconazole r_itra L1,2 O 44 Amphotericin-B r_ampho L1,2 O 45 Flucytosine r_flucyt L1,2 O 46 Echinocandins (ex. caspofungin) unique key=country code + network code + surveillance component code + hospital code + ICU code +
patient ID + Infection date + infection site + micro-organism code
1. Country code, network code, surveillance component code: link with network data table, see
2. Hospital
code: see 6.3.2
3. ICU code: see 6.3.2
4. Patient
ID: unique patient code. This code should be anonymous and prevent the network
coordination from tracing back the patient. However, a patient that is infected or admitted several times to the ICU should keep the same number. Since this number will also be used for validation studies, (only) the hospital should be able to link the number to the patient's file. 5. Date ICU admission (dd/mm/yyyy): date of admission in the ICU
6. Infection
(dd/mm/yyyy): date onset infection (date all necessary case definition criteria are met, date of sample if appropriate); include all infections occurring after day 2 in the ICU for which the infection date falls within the surveillance period; infections occurring on day 1 and day 2 may be reported but will not be included in the indicators. 7. Infection site (also see case definitions): PN1-5, BSI-A/B, UTIA-C, CRI1-3, CCO, OTH
Pneumonia : always specify subcategory ! PN1: protected sample + quantitative culture (104 CFU/ml BAL/103 PB,DPA) PN2: non-protected sample (ETA) + quantitative culture (106 CFU/ml) PN3: alternative microbiological criteria PN4: sputum bacteriology or non-quantitative ETA PN5: no microbiological criterion (only clinical criteria, see case definition) BSI: Bloodstream infection BSI-A: positive hemoculture recognized pathogen/ 2 HC+ skin contaminant BSI-B: CDC extension (see case definition) - optional UTI: Urinary tract infection (optional) UTI-A: microbiological y confirmed symptomatic UTI UTI-B: symptomatic UTI, not microbiologically confirmed UTI-C: asymptomatic bateriuria CRI: CVC-related infection (optional) CRI1: local catheter infection CRI2: generalized catheter infection CRI3: CVC-related bloodstream infection CCO: CVC colonization (optional) OTH: other ICU-acquired infection (optional) 8. Micro-organism: Required. 6 character code list (WHOCARE-based) – see code list in appendix; if
no micro-organism is available, specify either _NONID (Micro-organism not identified or not found), _NOEXA(examination not done) or _STERI (Sterile examination). 9-46. Susceptibility of micro-organisms to antimicrobials: U: unknown / not determined/ not available /
not applicable (default value); S: sensitive; I: intermediate; R: resistant; oxacillin susceptibility in S. aureus
is required;
Page 25 of 51 7 Control of the quality and validation of data
7.1 Role of the official network
The official networks in the countries are responsible for the quality of the data, for validation and
for data checks. They will be asked to provide an indication of the kind of selection in their data so
that the European centre can judge its representativeness. The official centres will be also be
asked to describe their procedures to guarantee the quality of the data.
7.2 Validation
nosocomial infections in the ICU
7.2.1 External data validation
The primary objective of a validation study is to determine the sensitivity and the specificity of the
surveillance as well as some other parameters such as the exhaustiveness of the denominator and
the accurateness of risk factors collected in the surveillance.
The method for the validation of nosocomial infections in the ICU depends on the infection type.
Laboratory-confirmed infections such as bloodstream infection may be traced directly from the
laboratory information system. For the validation of other infections, e.g. pneumonia, a sample of
patient files reported negative to the surveillance should be examined by a trained investigator in
order to estimate the number of false negatives. This sample should be big enough in order to
obtain results at the network level with a reasonably small confidence interval. The detailed
methodology of external data validation will be addressed during training sessions and is
developed elsewhere. In any case, validation is a very labour-intensive work involving mainly the
members of the national coordination team.
7.2.2 Internal data validation
Data should also be validated in the hospital whenever the collected data appear to be
inconsistent, for example checking of missing information by the person in charge of data entering.
The user software in the hospital should also include data entry checks that prohibits the user of
entering impossible data or omitting essential data.
The automatic creation of lists of possible infections (e.g. based on positive laboratory results or
antibiotic use) that is regularly submitted to the clinician for validation (check whether or not it was
an ICU-acquired infection that matches the case definition), may be more efficient in case finding
than relying on the active step of reporting an infection. Electronic surveillance (automatic data
collection from existing databases) will also have an impact on the workload of the surveillance,
which is essential for the sustainability of the surveillance at long term.
7.3 Role of the HELICS management team
When receiving the data, the HELICS data manager will realise a new check of the quality of data
for completeness of information and consistency. The modalities of the consistency checks will be
defined in the appropriate validation tools.
Page 26 of 51 8 Confidentiality
8.1 Patient
It will not be possible to identify individual patients in the European database on NI in the ICU by coding patient information at the hospital level or at the level of the official networks in the countries. However, for validation purposes, the hospitals should be able to trace back patients based on anonymous unique patient numbers. 8.2 Hospital and ICU confidentiality
A unique code is assigned to each hospital (unit) by the national surveillance system. The key
linking each hospital (unit) to its HELICS code remains strictly within the national surveillance
system to secure confidentiality. It is not to be transmitted to any other organization under any
circumstance. This number will be used for correspondence and feedback.
8.3 Publication
The data will be used to generate European annual reports on nosocomial infections in the ICU, reference tables on the internet, mapping of pathogen-specific incidence of nosocomial infections in European ICUs (mapping) and scientific publications. Official networks in the countries have to provide written consent with any publication before publication. Authorships will be dealt with according to the authorship regulations used by the British Medical Journal; in any publication reference wil be made to the official networks in the countries, including their acronym and contact information, if desired by the networks. Page 27 of 51 9 Data flow, accessibility and storage
Most of these topics are developed in the Standard Operating Manual for the surveillance of nosocomial infections. The data files to be exported for the surveillance of nosocomial infections in intensive care units are the following: (Unit-based
File (table) name Description
Country and network data Unit-based denominator data icu_inf & icu_res* Optional infection & AMR data ICU patient data, level 2 minimal data day-by-day exposure data central venous catheter data antimicrobial use data Level 1 data are the minimal data set to be transmitted by participating networks. Level 2 data are
more complete and are compatible with level 1 data. Therefore, they may replace or complete level
1 data. For option a additional variables in tables icu_p and icu_e are required.
* When both icu_inf and icu_res are used they replace table icu_i.
Page 28 of 51 10 References
(1) Decision N° 2119/98/EC of the European Parliament and of the Council of 24 September 1998 setting up a network for the epidemiological surveillance and control of communicable diseases in the Community. Official Journal of the European Communities 1998:L (2) HELICS. Development of a European network on nosocomial infections. Implementation Phase I. Final Report. 30-6-2002. (3) Brun-Buisson C, Abrouk F, Legrand P, Huet Y, Larabi S, Rapin M. Diagnosis of central venous catheter-related sepsis. Critical level of quantitative tip cultures. Arch Intern Med 1987; 147(5):873-877. (4) Maki DG, Weise C, Sarafin H. A semiquantitative culture method for identifying intravenous-catheter-related infection. N Engl J Med 1977; 296:1305-1309. (5) Blot F, Nitenberg G, Brun-Buisson C. New tools in diagnosing catheter-related infections. Support Care Cancer 2000; 8(4):287-292. (6) Quilici N, Audibert G, Conroy MC, Bollaert PE, Guillemin F, Welfringer P et al. Differential quantitative blood cultures in the diagnosis of catheter-related sepsis in intensive care units. Clin Infect Dis 1997; 25(5):1066-1070. (7) Guidelines for the utilisation of intensive care units. European Society of Intensive Care Medicine. Intensive Care Med 1994; 20(2):163-164. (8) Geffers C, Gastmeier P, Brauer H, Daschner F, Ruden H. Surveillance of nosocomial infections in ICUs: is postdischarge surveillance indispensable? Infect Control Hosp Epidemiol 2001; 22(3):157-159. (9) Hugonnet S, Eggimann P, Sax H, Touveneau S, Chevrolet JC, Pittet D. Intensive care unit-acquired infections: is postdischarge surveillance useful? Crit Care Med 2002; 30(12):2636-2638. (10) Suetens C, Leens E, Morales I, Colardyn F. Risk score for the prediction of ICU-acquired pneumonia and bacteraemia. 5th International Conference of the Hospital Infection Society, Edinburgh, 15-18 September 2002 2002;Book of Abstracts:122. (11) Joly C, Beaucaire G. C CLIN Paris-Nord. Réseau de surveillance des infections liées aux cathéters veineux centraux dans les services de réanimation adulte REACAT. Résultats 2001-2002. 1-75. 2002. (12) Le Gall JR, Lemeshow S, Saulnier F. A new Simplified Acute Physiology Score (SAPS II) based on a European/North American multicenter study. JAMA 1993; 270(24):2957-2963. (13) Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Crit Care Med 1985; 13(10):818-829. Page 29 of 51 11 Appendices
11.1 Appendix 1: Participants to the meetings and the elaboration of the ICU
protocol
AUSTRIA

Michael HIESMAYR1,2 AKH Universitätskliniken Helsinki University Central Hospital Maria WOSCHITZ-MERKAC5 Bundesministerium für Gesundheit und Frauen Petra GASTMEIER1,4 Medizinische HochSchule Hannover Francis COLLARDYN2 Christine GEFFERS1,4 Belgian Society of Intensive Care Medicine and Freie Universität Berlin Institut für Hygiene Universitair Ziekenhuis Scientific Institut of Public Health National Disease Surveillance Centre, Unit of Epidemiology LUXEMBOURG
Ingrid MORALES1,4 Margaret HEMMER2 Scientific Institut of Public Health Unit of Epidemiology Centre Hospitalier du Luxembourg, Jean-Claude SCHMIT3 National Service of Infectious Diseases Amtssygehused i Herlev Ringvej, Centre Hospitalier de Luxembourg THE NETHERLANDS
C.Clin Sud-Est, Lyon Centraal Begeleigings Orgaan (CBO) Centre Hospitalier Lyon-Sud Chairman ESICM Infection Akershus University Hospital University of Oslo Höpital Saint-Joseph – Service Réanimation Clémence JOLY1,4 Infection Control nurse association C-CLIN Paris Nord Norwegian Institute of Public Health Nils SMITH-ERICHSEN1,2 Akershus University Hospital Centre Hospitalier Lyon-Sud UNITED KINGDOM
Jacques FABRY1,4 Barry COOKSON3,4 Laboratoire d'Epidémiologie et Santé Publique Laboratory of Healthcare Associated Infection Page 30 of 51 Health Protection Agency PORTUGAL
Eduardo GOMES DA SILVA1,2 UCIP Hospital do Desterro Scottish Centre for Infection & Environmental HAI Project Team Comissào de Controlo de Infecçào Hospitalar Hosp. S. Antonio dos Capuchos/Desterro Georgia DUCKWORTH1,4 Health Protection Agency José Artur PAIVA2 Faculdade de Medicina do Porto Juan Alonso ECHANOVE1,4 Epidemic Intelligence Service (EIS) Mercedes PALOMAR1,2 Hospital Vall d'Hebron Barcelona Josu INSAUSTI2 Soins Intensifs Navarra 1 National/Regional network for the surveillance of nosocomial infections - coordination; 2 Intensivist, NI expert; 3 Microbiologist/Infectious diseases specialist; 4 Epidemiologist; 5 Ministry of Health Page 31 of 51 11.2 Appendix 2: Microorganism code list

Note: The code list is adapted from the original WHOCARE coding system. The current list is a selection
of micro-organisms based on their frequency of occurrence in nosocomial infections in different EU
networks and infection types and/or on their public health importance. The minimal list represents the
minimal level of detail that should be provided by every network. Networks/countries preferring to use the
complete WHOCARE list may obtain the database from the HELICS coordination centre.

Micro-organism selection and minimal list
Microorganism

Gram + cocci
Staphylococcus aureus Staphylococcus epidermidis Staphylococcus haemolyticus Coag-neg. staphylococci, not specified Other coagulase-negative staphylococci (CNS) Staphylococcus sp., not specified Streptococcus pneumoniae Streptococcus agalactiae (B) Streptococcus pyogenes (A) Other haemol. Streptococci (C, G) STRHCG Streptococcus sp., other Streptococcus sp., not specified Enterococcus faecalis Enterococcus faecium Enterococcus sp., other Enterococcus sp., not specified Gram-positive cocci, not specified Other Gram-positive cocci Gram - cocci
Moraxella catharralis Moraxella sp., other Moraxella sp., not specified Neisseria meningitidis Neisseria sp., other Neisseria sp., not specified Gram-negative cocci, not specified Other Gram-negative cocci Gram + bacilli
Corynebacterium sp. Bacillus sp. Lactobacillus sp. Listeria monocytogenes Gram-positive bacilli, not specified Other Gram-positive bacilli Enterobacteriaceae Citrobacter freundii
Citrobacter koseri (e.g. diversus) Citrobacter sp., other Citrobacter sp., not specified Enterobacter cloacae Enterobacter aerogenes Enterobacter agglomerans Enterobacter sakazakii Enterobacter gergoviae Enterobacter sp., other Enterobacter sp., not specified Page 32 of 51 Escherichia coli Klebsiella pneumoniae Klebsiella oxytoca Klebsiella sp., other Klebsiella sp., not specified Proteus mirabilis Proteus vulgaris Proteus sp., other Proteus sp., not specified Serratia marcescens Serratia liquefaciens Serratia sp., other Serratia sp., not specified Hafnia sp. Morganella sp. Providencia sp. Salmonella enteritidis Salmonella typhi or paratyphi Salmonella typhimurium Salmonella sp., not specified Salmonella sp., other Shigella sp. Yersinia sp. Other enterobacteriaceae Enterobacteriaceae, not specified Gram - bacilli
Acinetobacter baumannii Acinetobacter calcoaceticus Acinetobacter haemolyticus Acinetobacter lwoffii Acinetobacter sp., other Acinetobacter sp., not specified Pseudomonas aeruginosa Stenotrophomonas maltophilia Burkholderia cepacia Pseudomonadaceae family, other Pseudomonadaceae family, not specified Haemophilus influenzae Haemophilus parainfluenzae Haemophilus sp., other Haemophilus sp., not specified Legionella sp. Achromobacter sp. Aeromonas sp. Agrobacterium sp. Alcaligenes sp. Campylobacter sp. Flavobacterium sp. Gardnerella sp. Helicobacter pylori Pasteurella sp. Gram-neg Bacilli, not specified Other Gram-neg Bacilli, non enterobacteriaceae GNBOTH Anaerobic bacilli
Bacteroïdes fragilis Page 33 of 51 Bacteroïdes other Clostridium difficile Clostridium other Propionibacterium sp. Prevotella sp. Anaerobes, not specified Other bacteria
Mycobacterium, atypical Mycobacterium tuberculosis complex Chlamydia sp. Mycoplasma sp. Actinomyces sp. Nocardia sp. Candida albicans Candida glabrata Candida tropicalis Candida parapsilosis Candida sp., other Candida sp., not specified Aspergillus fumigatus Aspergillus niger Aspergillus sp., other Aspergillus sp., not specified Adenovirus VIRADV Cytomegalovirus (CMV) Enterovirus (polio, coxsackie, echo) Hepatitis A virus Hepatitis B virus Hepatitis C virus Herpes simplex virus Human immunodeficiency virus (HIV) Influenza A virus Influenza B virus Influenza C virus Parainfluenza virus Respiratory syncytial virus (RSV) Rhinovirus VIRRHI Rotavirus VIRROT Varicella-zoster virus Virus, not specified Micro-organism not identified or not found
Examination not done
Sterile examination
_NONID: evidence exists that a microbiological examination has been done, but the micro-organism can not be correctly classified or the result of the examination can not be found; _NOEXA: no diagnostic sample taken, no microbiological examination done; _STERI: a microbiological examination has been done, but the result was negative (e.g. negative culture) Page 34 of 51 Antimicrobial resistance
1. Tracer antimicrobial resistance fenotypes

S. aureus*
Enterococcus faecalis and
faecium
ampi-S ampi-R vanco-R Acinetobacter baumannii
Pseudomonas aeruginosa
*minimal data=S.aureus, MSSA or MRSA
code STAAUR/0 for MSSA, STAAUR/1 for MRSA, STAAUR/-1 if unknown
R = intermediate or resistant
Note : an I strain is coded as resistant (I = R)
S = sensitive
oxa = oxacillin GISA = intermediate or resistant to glycopeptides (MIC vancomycin or teicoplanin)vanco = vancomycin ampi = penicillin A or amoxicillin C3 = cefotaxim or ceftazidim ESBL = Extended spectrum beta-lactamase producer ticar = ticarcillin or piperacillin CAZ = ceftazidim unk = unknown

2. Optional antibiogram

Instead of using a predefined list of antimicrobial resistance "tracer" phenotypes, networks may
prefer to use complete or partial antibiogram data. The complete list is given in Appendix (data
collection forms) and in section 6.3.5. (table icu_res).
Page 35 of 51 11.3 Appendix 3: List of antimicrobials (from ABC Calc 1.91)
ATC_cl ATC_cl_label

Included antibacterials (+ ATC code)
J01A Tetracyclines Demeclocycline (J01AA01), Doxycyline (J01AA02), Chlortetracycline (J01AA03), Lymecycline (J01AA04), Metacycline (J01AA05), Oxytetracycline (J01AA06), Tetracycline (J01AA07), Minocycline (J01AA08), Rolitetracycline (J01AA09), Penimepicycline (J01AA10), Clomocycline (J01AA11), Tet.+chlor.+demecl. (J01AA20), Other comb. of tetracyclines (J01AA20), Oxytetracycline combinations (J01AA56) J01B Amphenicols (J01BA01), Thiamphenicol (J01BA02) J01CA_1 Penicil ins, extended spectrum Ampicillin (J01CA01), Pivampicillin (J01CA02), Amoxicillin without anti-pseudomonal activity (J01CA04), Bacampicillin (J01CA06), Epicillin (J01CA07), Pivmecillinam (J01CA08), Mecillinam (J01CA11), Metampicillin (J01CA14), Talampicillin (J01CA15), Temocillin (J01CA17), Hetacillin (J01CA18), Pivampi. + pivmecillinam (J01CA20), Other combinations (J01CA20), Ampicillin combinations (J01CA51) J01CA_2 Penicillins, extended spectrum with Carbenicillin (J01CA03), Carindacillin (J01CA05), anti-pseudomonal activity Azlocillin (J01CA09), Mezlocillin (J01CA10), Piperacillin (J01CA12), Ticarcillin (J01CA13), Sulbenicillin (J01CA16), Combinations (J01CA20) Beta-lactamase sensitive penicillins Benzylpenicillin (J01CE01), Phenoxymethylpenicillin (J01CE02), Propicillin (J01CE03), Azidocillin (J01CE04), Pheneticillin (J01CE05), Penamecillin (J01CE06), Clometocillin (J01CE07), Benzathine benzylpenicillin (J01CE08), Procaine penicillin (J01CE09), Benzathine phenoxymethylpenicillin (J01CE10), Procaine pen.+benzylpen.(1800:360) (J01CE30), Combinations (other) (J01CE30) J01CF Beta-lactamase resistant penicillins Dicloxacillin (J01CF01), Cloxacillin (J01CF02), Methicillin (J01CF03), Oxacillin (J01CF04), Flucloxacillin (J01CF05) Beta-lactamase inhibitors Sulbactam (J01CG01), Tazobactam (J01CG02) J01CR_1 Comb. of penicillins, incl. beta- Ampicillin and enzyme inhibitor (J01CR01), Amoxicillin and lactamase inhib., without anti- enzyme inhibitor (J01CR02), Sultamicillin (J01CR04) J01CR_2 Comb. of penicillins, incl. beta- Ticarcillin and enzyme inhibitor (J01CR03), lactamase inhib., with anti-pseud. Piperacillin and enzyme inhibitor (J01CR05) activity J01CR_3 Other combinations of penicillins Ampicillin + cloxacillin (J01CR50), Ampicillin + flucloxacillin (J01CR50), Other combinations of penicillins (J01CR50) J01DA_1 First generation cephalosporins Cefalexin (J01DA01), Cefaloridine (J01DA02), Cefalotin (J01DA03), Cefazolin (J01DA04), Cefadroxil (J01DA09), Cefazedone (J01DA15), Cefatrizine (J01DA21), Cefapirin (J01DA30), Cefradine (J01DA31), Cefacetrile (J01DA34), Cefroxadine (J01DA35), Ceftezole (J01DA36) J01DA_2 Second generation cephalosporins Cefoxitin (J01DA05), Cefuroxime (Oral) (J01DA06), Cefuroxime (Parenteral) (J01DA06), Cefamandole (J01DA07), Cefaclor (J01DA08), Cefotetan (J01DA14), Cefonicide (J01DA17), Cefotiam (J01DA19), Loracarbef (J01DA38), Cefmetazole (J01DA40), Cefprozil (J01DA41) Page 36 of 51 APPENDIX: List of antimicrobials (continued)
ATC_cl ATC_cl_label
Included antibacterials (+ ATC code)
J01DA_3 Third generation cephalosporins Cefotaxime (J01DA10), Ceftazidime (J01DA11), Cefsulodin (J01DA12), Ceftriaxone (J01DA13), Cefmenoxime (J01DA16), Latamoxef (J01DA18), Ceftizoxime (J01DA22), Cefixime (J01DA23), Cefodizime (J01DA25), Cefetamet (J01DA26), Cefpiramide (J01DA27), Cefoperazone (J01DA32), Cefpodoxime (J01DA33), Ceftibuten (J01DA39), Cefdinir (J01DA42), Ceftriaxone, combinations (J01DA63) J01DA_4 Fourth generation cephalosporins Cefepime (J01DA24), Cefpirome (J01DA37) J01DF Monobactams Meropenem (J01DH02), Imipenem and enzyme inhibitor (J01DH51) Sulfonamides: Trimethoprim and Trimethoprim (J01EA01), Brodimoprim (J01EA02), J01EB Short-acting Sulfaisodimidine (J01EB01), Sulfamethizole (J01EB02), Sulfadimidine (J01EB03), Sulfapyridine (J01EB04), Sulfafurazole (J01EB05), Sulfanilamide (J01EB06), Sulfathiazole (J01EB07), Sulfathiourea (J01EB08), Combinations (J01EB20) J01EC Intermediate sulfonamides Sulfamethoxazole (J01EC01), Sulfadiazine (J01EC02), Sulfamoxole (J01EC03), Combinations (J01EC20), J01ED Long-acting Sulfadimethoxine (J01ED01), Sulfalene (J01ED02), Sulfametomidine (J01ED03), Sulfametoxydiazine (J01ED04), Sulfamethoxypyridazine (J01ED05), Sulfaperin (J01ED06), Sulfamerazine (J01ED07), Sulfaphenazole (J01ED08), Sulfamazon (J01ED09), Combinations (J01ED20) Combinations of sulfonamides and Sulfamethox. + trimeth. (40:8, 80:16) (J01EE01), trimethoprin, incl. deriv. Sulfamethox. + trimeth. (oth. comb.) (J01EE01), Sulfadiazine and trimethoprim (J01EE02), Sulfametrole and trimethoprim (J01EE03), Sulfamoxole and trimethoprim (J01EE04), Sulfadimidine and trimethoprim (J01EE05) J01FA Macrolides Erythromycin (J01FA01), Erythromycin ethylsuccinate tabl. (J01FA01), Spiramycin (J01FA02), Midecamycin (J01FA03), Oleandomycin (J01FA05), Roxithromycin (J01FA06), Josamycin (J01FA07), Troleandomycin (J01FA08), Clarithromycin (J01FA09), Azithromycin (J01FA10), Miocamycin (J01FA11), Rokitamycin (J01FA12), Dirithromycin (J01FA13), Flurithromycin (J01FA14), Telithromycin (J01FA15) J01FF Lincosamides (Oral) (J01FF01), Clindamycin (Parenteral) (J01FF01), Lincomycin (J01FF02), J01FG Streptogramins (J01FG01), Quinupristin/dalfopristin J01GA Aminoglycoside Streptomycin (J01GA01), Streptoduocin (J01GA02) (Parenteral) (J01GB01), Tobramycin (Inhal. sol.) (J01GB01), Gentamicin (J01GB03), Kanamycin (J01GB04), Neomycin (J01GB05), Amikacin (J01GB06), Netilmicin (J01GB07), Sisomicin (J01GB08), Dibekacin (J01GB09), Ribostamycin (J01GB10), Isepamicin (J01GB11) Page 37 of 51 APPENDIX: List of antimicrobials (continued)
ATC_cl ATC_cl_label
Included antibacterials (+ ATC code)
J01MA Fluoroquinolones (J01MA01), Ciprofloxacin (Oral) (J01MA02), Ciprofloxacin (Parenteral) (J01MA02), Pefloxacin (J01MA03), Enoxacin (J01MA04), Temafloxacin (J01MA05), Norfloxacin (J01MA06), Lomefloxacin (J01MA07), Fleroxacin (J01MA08), Sparfloxacin (J01MA09), Rufloxacin (J01MA10), Grepafloxacin (J01MA11), Levofloxacin (J01MA12), Trovafloxacin (J01MA13), Moxifloxacin (J01MA14), Gemifloxacin (J01MA15), Gatifloxacin (J01MA16) Other quinolones Rosoxacin (J01MB01), Nalidixic acid (J01MB02), Piromidic acid (J01MB03), Pipemidic acid (J01MB04), Oxolinic acid (J01MB05), Cinoxacin (J01MB06), Flumequine(J01MB07) Combinations of antibacterials Penicillins, comb. With other antibacterials (J01RA01), Sulfonamides, comb. (excl. trimethoprim)(J01RA02), Cefuroxime, comb. with other antibacterials (J01RA03) J01XA Glycopeptides (Parenteral) (J01XA01), Teicoplanin (J01XA02) J01XB Polymixins (Parenteral) (J01XB01), Polymyxin B (Parenteral) Steroid antibacterials Fusidic acid (J01XC01) Imidazole derivates Metronidazole (Parenteral) (J01XD01), Tinidazole (Parenteral) (J01XD02), Ornidazole (Parenteral) (J01XD03) J01XE Nitrofuran derivates Nitrofurantoin (J01XE01), Nifurtoinol (J01XE02), Other antibacterials Fosfomycin (Parenteral) (J01XX01), Fosfomycin (Oral) (J01XX01), Xibornol (J01XX02), Clofoctol (J01XX03), Spectinomycin (J01XX04), Methenamine, hippurate, (J01XX05), Methenamine, mandelate (J01XX05), Mandelic acid (J01XX06), Nitroxoline (J01XX07), Linezolid (J01XX08) Antimycotics for systemic use Amphotericin B (J02AA01), Hachimycin (J02AA02), Miconazole (J02AB01), Ketoconazole (J02AB02), Fluconazole (J02AC01), Itraconazole (J02AC02), Voriconazole (J02AC03) Flucytosine (J02AX01) , Caspofungin (J02AX04), Micafungin (J02AX05), Nystatin (J02AX10) Page 38 of 51 11.4 Appendix 4: Calculation of denominator data in unit-based surveillance.
Example based on a list (database) including at least the admission date to the ICU and discharge
date from the ICU for each patient.
Include ICU patients from list/database in analysis if:
1) admis_dt>=start_dt AND admis_dt<=end_dt (patients admitted within surveillance period)
OR
2) disch_dt>=start_dt AND disch_dt<=end_dt (patients discharged within surveillance period)
OR
3) admis_dt<start_dt AND disch_dt>end_dt (patients present during the entire surveillance period)
* step 1: compute length of stay (LOS) per patient los= disch_dt – admis_dt + 1 * step 2: compute days outside surveillance period days_out1 = start_dt – admis_dt (positive if ICU-days fall before start surveillance period) days_out2 = disch_dt – end_dt (positive if ICU-days fall after end surveillance period) recode days_out1 min/0 → 0 (all negative values recoded to 0) recode days_out2 min/0 → 0 (all negative values recoded to 0) *step 3: compute days in ICU within surveillance period (los_in) los_in= los - days_out1 - days_out2 *step 4: compute denominators a. N of new admissions in surveillance period, all= count (sum) of patients IF admis_dt>=start_dt AND admis_dt<=end_dt b. N of new admissions in surveillance period and staying more than 2 days count (sum) of patients IF admis_dt>=start_dt AND admis_dt<=end_dt AND los>2 c. N of patient-days in surveillance period, all= sum(los_in) d. N of patient-days in surveillance period, patients staying >2D = sum(los_in IF los>2) Figure: Patient-days to be counted in unit-based surveillance (level 1) for patients staying more than 2 calendar days in the ICU, example (blue=days included in denominator; red=days not included in denominator; dark blue=included infections). E.g., first patient: patient is admitted to the ICU on 25 December 2002, and is discharged on 8 January 2003. For the surveillance period January 2003, only 8 days are counted. Two infections occurring after day 2 in the ICU are both registered in the numerator data. E.g., fourth patient: this patient is not counted because the length of stay is less than 3 days. E.g., totals: the total number of patient-days for patients staying more than 2 days in this example is 70, the total number new admissions staying more than 2 days is 10. The totals for all patients (optional) are 75 and 13 respectively. 25/12/02 26/12/02 Page 39 of 51 11.5 Appendix 5. Risk scores definitions
SAPS II scoreThe Simplified Acute Physiology Score II (SAPS II) is one of the most used in ICU to evaluate the
probability of hospital or ICU mortality and a starting point for evaluation of the efficiency of a
intensive care unit. It includes 17 variables, 12 physiology variables and three underlying disease
variables.
Variable
DEFINITION
COMMENTS
The SAPS II components should The total score must be be measured 24 hours after computed adding the weighted admission to the ICU. The worst values. values within those 24 hours are to be recorded; each category of values has a weighted value in points. Use the patient's age (in years) at his last birthday. Use the worst value in 24 hours, either low or high heart rate; if it varied from cardiac arrest (11points) to extreme tachycardia (7points), assign 11 points Systolic blood pressure Use the same method as for heart rate: eg, if it varied from 60 mm Hg to 205 mm Hg, assign 13 points. Body temperature Use the highest temperature in degrees Centigrade or Fahrenheit If ventilated or continuous Only if the patient has been pulmonary artery pressure, use mechanical y ventilated. the lowest value of the ratio. Total urinary output in 24 hours Patients staying less than 48 hours are not included in the HELICS surveillance Serum urea or serum urea Use the highest value in mmol/L nitrogen level for serum urea, in mg/dL for serum urea nitrogen. Use the worst (high or low) WBC count according to the scoring sheet Serum potassium level Use the worst (high or low) in mmol/L, according to the scoring sheet Serum sodium level Use the worst (high or low) in 3 Le Gall JR, Lemeshow S, Saulnier F. A new simplified acute physiology score (SAPS II) based on a European / North American Multicenter Study. JAMA 1993; 270:2957-2963.
Page 40 of 51 mmol/L, according to the scoring sheet Serum bicarbonate level Use the lowest value in mEq/L. Use the highest value in µmol/L or mg/dL. Glasgow Coma score* Use the lowest value; if the This variable must be repeated patient is sedated, record the on the HELICS form. estimated Glasgow Coma Score before sedation (see definition below). Type of admission a) Unscheduled surgical, Patients added to the operating room schedule within 24 hours of the Patient whose surgery was scheduled at least 24 hours in advance. surgery within 1 week of admission to ICU. This variable must be repeated on the HELICS form. Select YES if HIV-positive with clinical complications such as Pneumocystis carinnii pneumonia, Kaposi's sarcoma, lymphoma, tuberculosis, or toxoplasma infection. Hematologic malignancy Select YES, if lymphoma, acute leukaemia or multiple myeloma. Metastatic cancer Select YES, if proven metastasis This variable must be repeated by surgery, computed on the HELICS form. tomographic scan, or any other method Page 41 of 51
SAPS II weights

Heart rate (beats/min) Systolic BP (mm Hg) Body temperature (°C) Only if ventilated or positive airway pressure (BPAP/CPAP) PaO2(mmHg)/FiO2 ratio e.g. 70 mmHg / 0.5 = 140 Urinary output (ml/day) Serum urea (mg/dl) WBC count (103/mm3) Serum potassium (mEq/L) Serum sodium (mEq/L) Bicarbonate (mEq/L) Bilirubin (mg/dl) Glasgow coma score (if patient is sedated, estimate status before sedation) Chronic diseases metastatic cancer9 hematol.malignancy10 Type of admission scheduled surgical0 unscheduled surgical8 APACHE 2 score
William A. Knaus, MD ; Elizabeth A. Draper, MS; Douglas P. Wagner, PhD; Jack E. Zimmerman, MD. APACHE II: A severity of disease classification system. Crit. Care Med. 1985; 818-829 Page 42 of 51









THE APACHE II SEVERITY OF DISEASE CLASSIFICATION SYSTEM

HIGH ABNORMAL RANGE LOW ABNORMAL RANGE PHYSIOLOGIC VARIABLE TEMPERATURE – rectal (C°) 38.5° – 38.9° MEAN ARTERIAL PRESSURE – mm Hg (ventricular response) RESPIRATORY RATE – (non ventilated or OXYGENATION: A aDO2 or PaO2 (mm Hg) a. FIO2 ≥ 0.5 record a A aDO2 b. FIO2 < 0.5 record only PaO2 SERUM SODIUM (mMol/L) SERUM POTASIUM (mMol/L) SERUM CREATININE (mg/100ml) (Double point score for acute renal failure) WHITE BLOOD COUNT (total/mm3) GLASGOW COMA SCORE (GCS) Score = 15 minus actual GCS A Total ACUTE PSYSIOLOGIC SCORE (APS) Sum of the 12 individual variable points Serum HCO2 (venous mMol/L) (Not preferred, use if no ABGs) C CHRONIC HEALTH POINTS CARDIOVASCULAR: New York Heart Association Class IV Assign points to age as If the patient has a history of severe organ system insufficiency or is RESPIRATORY: Chronic restrictive, obstructive or vascular 1.1 APACHE
disease resulting in severe exercise restriction, i e, unable to immuno-compromised assign points as follows for nonoperative or emergency postoperative patients – 5 climb stairs or perform household duties; or documented AGE (yrs) Points chronic hypoxia, hypercapnia, secondary polycythemia, severe pulmonary hypertension (>40mmHg); or respirator for elective postoperative patients – 2 points RENAL: Receiving chronic dialysis Organ Insufficiency or immuno-compromised state must have been IMMUNO-COMPROMISED: The patient has received therapy evident prior to this hospital admission and conform to the following
that suppresses resistance to infection, e g immuno- suppression, chemotherapy, radiation, long term or recent C Chronic Health LIVER: Biopsy proven cirrhosis and documented portal hypertension high dose steroids or has a disease that is sufficiently , episodes of past upper GI bleeding attributed to portal hypertension advanced to suppress resistance to infection e g, leukemia, Total ---- APACHE II or prior episodes of hepatic failure/encephalopathy/coma Page 43 of 51 Glasgow coma score Score Glasgow = Y + V + M
Best Eye Response Best Verbal Response Best Motor Response 1. No eye opening. 1. No verbal response 1. No motor response. 2. Eye opening to pain. 2. Incomprehensible 2. Extension to pain. 3. Eye opening to verbal 3. Flexion to pain. 3. Inappropriate words. 4. Withdrawal from 5. Localising pain. 6. Obeys Commands
Note that the phrase 'GCS of 11' is essentially meaningless, and it is important to break the figure
down into its components, such as E3V3M5 = GCS 11. A Coma Score of 13 or higher correlates
with a mild brain injury, 9 to 12 is a moderate injury and 8 or less a severe brain injury.
Glasgow Paediatric Coma ScoreThe Paediatric GCS is scored between 3 and 15, 3 being the worst, and 15 the best. It is
composed of three parameters: Best Eye Response, Best Verbal Response, and Best Motor
Response, as given below:
Best Eye Response. (4)
1. No eye opening. 2. Eye opening to pain. 3. Eye opening to verbal command. 4. Eyes open spontaneously. Best Verbal Response. (5) 1. No vocal response 2. Inconsolable, agitated 3. Inconsistently consolable, moaning. 4. Cries but is consolable, inappropriate interactions. 5. Smiles, oriented to sounds, follows objects, interacts. Best Motor Response. (6) 1. No motor response. 2. Extension to pain. 3. Flexion to pain. 4. Withdrawal from pain. 5. Localising pain. 6. Obeys Commands. Note that the phrase 'GCS of 11' is essentially meaningless, and it is important to break the figure down into its components, such as E3V3M5 = GCS 11. A Coma Score of 13 or higher correlates with a mild brain injury, 9 to 12 is a moderate injury and 8 or less a severe brain injury. 4 Teasdale G., Jennett B., Assessment of coma and impaired consciousness. A practical scale. Lancet. 1974 Jul 13;2(7872):81-4. 5 http://www.trauma.org/scores/gpcs.html Page 44 of 51 11.6 Appendix 6. Comprehensive list of indicators
Bloodstream infection Incidence density of nosocomial # BSI (of all origin) >D2*1000/n of patient- bloodstream infection in the ICU Pathogen-specific bloodstream infection # BSI (of all origin, by pathogen) >D2*1000/n of patient-days Observed n of patients with BSI/ Expected Standardised bloodstream infection ratio n of patients with bloodstream infection Stratification of device-adjusted infection Infection rates by ICU-type Infection rates by risk factors Incidence density of nosocomial # pneumonia (of all origin) >D2*1000/n of pneumonia (clinical + microb. confirmed) in # PN with microbiol. documentation by semi-quantitative (BAL,PB…) or % microbiol. confirmed pneumonia quantitative culture of endotracheal aspirate/ total PN Pathogen-specific pneumonia incidence # pneumonia (of all origin, by pathogen) >D2*1000/n of patient-days Intubator-associated pneumonia rate in the # device-associated pneumonia*1000/n of intubation days Observed n of patients with pneumonia/ Standardised pneumonia ratio Expected n of patients with pneumonia Infection rates by ICU-type Stratification of infection rates Infection rates by risk factors Urinary tract infections Incidence density of nosocomial UTI in the # UTI >D2*1000/n of patient-days # UTI (of all origin, by pathogen) Pathogen-specific UTI incidence rate >D2*1000/n of patient-days # device-associated UTI*1000/n of urinary Catheter-associated UTI rate in the ICU Stratification of infection rates Infection rates by risk factors Catheter Infections Incidence density of catheter infections in # catheter-associated infections*1000/n of central line days (catheter-total) # catheter-associated infections by Idem, by insertion site insertion site*1000/n of central line days (catheter-total by site) Observed n of patients with catheter Standardised Catheter Infection ratio infection/ Expected n of patients with catheter infection Antimicrobial use in the ICU N of antibiotic treatment days/N of patient- Antimicrobial treatment utilization rate Ratio documented treatment/empiric N of Documented AB treatment days/ N of Empiric AB treatment days N of antibiotic treatment days/N of patient- Stratified AM use days by risk factors Device use in the ICU Central line utilization rate N of central line days/N of patient-days Intubation utilization rate N of days with intubation/N of pt-d N of non-invasive ventilation days/N of Non-invasive ventilation utilization rate Urinary catheter utilization rate N of urinary catheter days/N of pat-days Page 45 of 51 11.7 Appendix 7: Example of graphical output of level 1 surveillance at various
levels

Legend: upper-left: comparison of individual infection rates with other ICUs participating to the network;
Upper right: follow-up of indicators in time compared to national percentiles (10,50,90); Lower left: mapping
of pathogen-specific incidence at the national level; Lower right: international mapping of indicators
- quired pneumonia 0 – Jun0
Page 46 of 51 11.8 Appendix 8: Data collection forms (models)
Page 47 of 51 HELICS Level 1 data collection form L1: DENOMINATOR DATA

Hospital _
Unit Period from: to: _ Patients staying > 2 days (>=3 d) All patients (o) Number of admissions to ICU Number of patient-days
L1: INFECTION DATA

Admission Infection
Patient ID
AMT° VAL°
48h ORI°
Patient ID: unique patient code; Adm.dt. ICU: admission date in unit; Infection date: date onset infection (date of sampling if appropriate); Infection Site: BSI-A/B bloodstream infection; PN1-PN5: ICU-acquired pneumonia; UTI-A/B/C urinary tract infection; CRI1-CRI3: CVC infection; (CCO:catheter colonization); OTH: other infection site; MO1-MO3/R: 6 character micro-organism code/resistance profile code (e.g. STAAUR/0=MSSA, STAAUR/1=MRSA, STAAUR/-1=S.aureus, resistance unknown); IDU 48: invasive device exposure in 48 hours before infection, required if site=pneumonia (intubation), optional for other infection sites; BSI ORI: Origin of bloodstream infection(o):C:catheter-associated;S:secondary (pulmonary (S-PUL), urinary (S-UTI), digestive (S-DIG), surgical site infection (S-SSI), skin and soft tissue (S-SST), other (S-OTH);U:unknown; AMT: antimicrobial treatment (Y if AMT was started); VAL: for validation (e.g. in case of electronic surveillance) if infection is nosocomial and matches case definition, Y/N;°=optional level 1 form Page 48 of 51 NOSOCOMIAL INFECTION SURVEILLANCE IN INTENSIVE CARE UNITS
Level 2: basic data set for patient-based surveillance Country: _ Hospital code: _ Unit: Patient ID:
Date ICU admission: - - _ Date ICU discharge: - - _
Discharge status
alive death in ICU
Gender: M F U
Age (yrs) : _
Origin of the patient:
ward in this/other hospital ICU community long-term care Admission date in hospital: / / _ (dd/mm/yyyy)

SAPS II score
APACHE II score

Type of admission:
medical
scheduled surgical unscheduled surgical Impaired immunity
Antimicrobial treatment +/- 48 Hrs around admission Yes No
Central venous catheter(s) Urinary catheter (o) a Registration can cover more than 14 days Option a: Risk score for ICU-acquired pneumonia and bloodstream infections (additional variables) Acute coronary care Yes No
Surgery site (within last 30 days before admission, incl. day of admission) : no surgery
coronary surgery other cardiac other thoracic other major vascular abdominal neurosurgery other sites Glasgow Coma Scale°: CGSestimated _ ; CGSmeasured _
Mechanical ventilation non-invasive° Naso/oro-intestinal tube present Feeding through naso/oro-intestinal tube Parenteral nutrition Option b: Option central venous catheter surveillance For each central venous catheter >1 organ failure CVC numbera date a More than 4 CVC registrations are allowed b 1=subclavia, 2=jugular, 3=femoral, 4=other site; c Y/N Option c: Antimicrobial use in the ICU *by day: P(prophylaxis)/ S (SDD)// E (empiric therapy)/ M (therapy based on micro-organism or gram stain) or A (AMT based on antibiogram)
More than 4 Antimicrobial registrations are allowed
Helics-ICU Level 2 : patient-based surveillance data collection form Page 49 of 51

LEVEL 2 INFECTION DATA
Hospital code: ICU code: _ Patient ID: _
Admission date in the ICU:

Infection date Site
AMT° VAL°
48h ORI°
Patient ID: unique patient code ; Adm.dt. ICU: admission date in unit; Infection date: date onset infection (date of sampling if appropriate); Infection Site: BSI-A/B bloodstream infection; PN1-PN5: ICU-acquired pneumonia; UTI-A/B/C urinary tract infection; CRI1-CRI3: CVC infection; (CCO: catheter colonization); OTH: other infection site; MO1-MO3/R: 6 character micro-organism code/resistance profile code (e.g. STAAUR/0=MSSA, STAAUR/1=MRSA, STAAUR/-1=S.aureus, resistance unknown); IDU 48: invasive device exposure in 48 hours before infection, required if site=pneumonia (intubation), optional for other infection sites; BSI ORI: Origin of bloodstream infection(o):C:catheter-associated;S:secondary (pulmonary (S-PUL), urinary (S-UTI), digestive (S-DIG), surgical site infection (S-SSI), skin and soft tissue (S-SST), other (S-OTH);U:unknown; AMT: antimicrobial treatment (Y if AMT was started); VAL: for validation (e.g. in case of electronic surveillance) if infection is nosocomial and matches case definition, Y/N;CVC num: CVC number – for CCO in option c (catheter colonization), link with CVC risk factors; °=optional Helics-ICU Level 2 : patient-based surveillance data collection form Page 50 of 51
INFECTION DATA & ANTIMICROBIAL RESISTANCE DATA (optional) (one form per infection)
Hospital code: ICU code: _ Patient ID: _
Admission date in the ICU: Infection date: _ Infection type _
Invasive device in 48h before infection: Y / N Origin of bloodstream infection _
Antimicrobial treatment°: Y / N
Validated infection°: Y / N
CVC number°: _
Micro-organism1 Micro-organism2 Micro-organism code : Amoxicillin-clavulanic acid Methicillin/oxacillin (B-lactamase res.pen.) Piperacillin/ticarcillin (anti-pseudom. peni.) Cefalotin/cefazolin (1st gen. ceph.) Cefuroxim/cefamandole/cefoxitin (2nd GC) Cefotaxime/ceftriaxone (3rd GC) Ceftazidime (anti-pseudom. 3rd GC) Cefepime/cefpirome (4th GC) Carbap. Meropenem/imipenem Sulfa & tr. Co-trimoxazole (sulfamethox. + trimeth.) Tetracycl. Tetracycline/doxycycline/minocycline Macrolid. Erythromycin (macrolides) Clindamycin (lincosamides) similar Quinupristin-dalfopristin (streptogramins) Ciprofloxacin/ofloxacin Oth. quin. Nalidixic acid Glycopep. Vancomycin/teicoplanin Polymyx. Colistin Other Fosfomycin Patient ID: unique patient code ; Adm.dt. ICU: admission date in unit; Infection date: date onset infection (date of sampling if appropriate); Infection Site: BSI-A/B bloodstream infection; PN1-PN5: ICU-acquired pneumonia; UTI-A/B/C urinary tract infection; CRI1-CRI3: CVC infection; (CCO: catheter colonization); OTH: other infection site; Invasive device exposure in 48 hours before infection, required if site=pneumonia (intubation), optional for other infection sites; BSI ORI: Origin of bloodstream infection(o):C:catheter-associated (C-CVC: central catheter; C-PER: peripheral catheter; C-ART: arterial catheter; S:secondary (pulmonary (S-PUL), urinary (S-UTI), digestive (S-DIG), surgical site infection (S-SSI), skin and soft tissue (S-SST), other (S-OTH);U:unknown; AMT: antimicrobial treatment (Y if AMT was started); VAL: for validation (e.g. in case of electronic surveillance) if infection is nosocomial and matches case definition, Y/N;CVC num: CVC number – for link with option c data (catheter infections); Micro-organism: 6 character micro-organism code (e.g. STAAUR) - if no micro-organism is available, specify either _NONID (Micro-organism not identified or not found), _NOEXA(examination not done) or _STERI (Sterile examination); Antimicrobial resistance data: U: unknown/ not available / not applicable; S: sensitive; I: intermediate; R: resistant; °=optional Helics-ICU : infection & antimicrobial resistance form Page 51 of 51

Source: http://www.sicsag.scot.nhs.uk/hai/helics_protocol.pdf

Op-gbev120037 1046.1053

Weak 50-mRNA Secondary Structures in Short EukaryoticGenes Yang Ding, Premal Shah, and Joshua B. Plotkin* Department of Biology, University of Pennsylvania *Corresponding author: E-mail: [email protected] Accepted: September 21, 2012 Experimental studies of translation have found that short genes tend to exhibit greater densities of ribosomes than long genes ineukaryotic species. It remains an open question whether the elevated ribosome density on short genes is due to faster initiation orslower elongation dynamics. Here, we address this question computationally using 50-mRNA folding energy as a proxy for translationinitiation rates and codon bias as a proxy for elongation rates. We report a significant trend toward reduced 50-secondary structure inshorter coding sequences, suggesting that short genes initiate faster during translation. We also find a trend toward higher 50-codonbias in short genes, suggesting that short genes elongate faster than long genes. Both of these trends hold across a diverse set ofeukaryotic taxa. Thus, the elevated ribosome density on short eukaryotic genes is likely caused by differential rates of initiation, ratherthan differential rates of elongation.

Mcneil, a johnson & johnson subsidiary fda case study

McNeil, a Johnson & Johnson Subsidiary FDA Case StudyWarren AdisHagan School of Business, Iona College, [email protected] Follow this and additional works at: Recommended CitationAdis, Warren (2014) "McNeil, a Johnson & Johnson Subsidiary FDA Case Study," Communications of the IIMA: Vol. 14: Iss. 3, Article2.Available at: This Article is brought to you for free and open access by CSUSB ScholarWorks. It has been accepted for inclusion in Communications of the IIMA byan authorized administrator of CSUSB ScholarWorks. For more information, please contact .