ONKO-KISS Protocol: Healthcare-associated Infection ... ·...

Krankenhaus-Infektions-Surveillance-System (KISS)

Hospital Infection Surveillance System

ONKO-KISS Protocol:

Healthcare-associated Infection Surveillance in

Hematology/Oncology Wards

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ONKO-KISS: Protocol on HAI Surveillance in hematology/oncology wards © 2012 National Reference Center

for the Surveillance of Nosocomial Infections

www.nrz-hygiene.de

This draft version is not approved for citation or application.

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Table of Contents: 1. Introduction ........................................................................................................................................ 4

2 Goals of ONKO-KISS .......................................................................................................................... 5

3. Requirements for participation in ONKO-KISS by hematology/oncology units and duties of

KISS institutions .................................................................................................................................... 6

4. Methods .............................................................................................................................................. 7

4.1 Patient data collection ............................................................................................................................... 7

4.2 Infection data collection ............................................................................................................................ 7

4.3 Calculation of reference data ................................................................................................................... 7

4.4 Comparing infection rates ........................................................................................................................ 8

5 General definition principles by the CDC and specified definitions ............................................. 9

6 Definitions ......................................................................................................................................... 11

6.1 Primary Bloodstream Infection (BSI) .................................................................................................... 11

6.2 Pneumonia ............................................................................................................................................... 12

6.2.1 Definitions for fungal pneumonia and Legionella pneumonia (Legionnaire’s disease) ......... 13

7. Surveillance specifications ............................................................................................................ 15

7.1 Patient data collection forms for ONKO-KISS, ONKO-KISS_PAED and ONKO-KISS_AL ......... 15

7.1.1 ONKO-KISS and ONKO-KISS_PAED .......................................................................................... 19

7.1.2 Specifications for ONKO-KISS_AL (for acute leukemia) ........................................................... 19

7.2 Patient progress form ............................................................................................................................. 21

7.3 BSI pathogen resistance surveillance .................................................................................................. 21

8. Documentation specifications ....................................................................................................... 22

8.1 Patient information form ......................................................................................................................... 22

8.2 Abbreviations of underlying illnesses ................................................................................................... 22

8.3 ICD-10 codes for acute leukemias ........................................................................................................ 22

8.4 Pathogen abbreviations .......................................................................................................................... 23

8.5 Examples for determining neutropenia as a surveillance period ...................................................... 27

9 References ........................................................................................................................................ 29

10 Appendix ......................................................................................................................................... 30

10.1 Patient data collection form for ONKO-KISS and ONKO-KISS_PAED: Patients with bone

marrow or blood stem cell transplantations (BMT, PBSCT, cord blood) ............................................... 30

10.2 Patient data collection form for ONKO-KISS_AL: Patients with AML or ALL without primary

transplantation and receiving standard chemotherapy............................................................................. 31

10.3 Data collection forms for pneumonia .................................................................................................. 32

10.4 Progress form for infection surveillance, Hematological /Oncological Units ................................ 35

11 Legal Notice .................................................................................................................................... 36

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1. Introduction

It has been known for over twenty years that the continuous, systematic collection, analysis

and interpretation of data relevant to nosocomial infections as well as feedback for doctors

and nurses can reduce the frequency of these infections. This kind of internal quality

assurance is known as surveillance. Data from one hospital are more valid and more

effective when they are compared with those from other hospitals. The frequency of infection

at one station or ward can only be determined in context with data from other stations and

departments. In order to avoid false conclusions, comparisons are only possible when

identical methods of data collection with fixed diagnostic definitions are used.

The Hospital Infection Surveillance System (German: Krankenhaus-Infektions-Surveillance-

System = KISS) was launched in 1997 by the National Reference Center for the Surveillance

of Nosocomial Infections (German: Nationales Referenzzentrum = NRZ). ONKO-KISS, a

module for the surveillance of healthcare-associated infections in patients over 16 years of

age with bone marrow or blood stem cell transplantations, was developed in late 2000. A

similar module, ONKO-KISS_PAED, was launched in 2003 to include patients under 16 or in

pediatric wards. ONKO-KISS_AL, similarly, was started in 2005 to include patients over 16

with acute leukemia (AML or ALL).

The project is based at the Institute for Environmental Medicine and Hospital Hygiene

(German: Institut für Umweltmedizin und Krankenhaushygiene = IUK) at the University Clinic

Freiburg.

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2 Goals of ONKO-KISS

Patients receiving either autologous or allogeneic bone marrow or blood stem cell

transplantation have one of the highest rates of infection of all oncology patients, especially

in the neutropenic phase. Because patients with autologous and allogeneic transplantations

have varying infection rates, the data for these groups are evaluated separately.

Bloodstream infections (BSI) and pneumonia are among the most frequent and most severe

healthcare-associated infections (HAI). For this reason, it makes sense to continuously track

healthcare-associated bloodstream infections and pneumonias in these patients, especially

in the neutropenic phase.

This surveillance protocol has the primary goal of providing participating institutions with

necessary specifications and definitions. This creates proper conditions for standardizing

data collection and data analysis. In this way, reference data can also be made available for

benchmarking and internal quality assurance.

Acute leukemia patients being treated with chemotherapy are also especially susceptible to

infection in the neutropenic phase and are included for this reason in ONKO-KISS.

ONKO-KISS, ONKO-KISS_PAED and ONKO-KISS_AL are evaluated separately. Reference

data are generated for ONKO-KISS and ONKO-KISS_AL. The reference data from ONKO-

KISS serve as a reference for ONKO-KISS_PÄD.

Other hematology or oncology departments can use the definitions contained within this

protocol to perform surveillance of HAIs. Analogical evaluation of surveillance data makes it

possible for these departments—after taking their unique situations into account—to

benchmark themselves in the reference data.

The basis for the following protocol is the (partially modified) CDC definitions for healthcare-

associated bloodstream infection and pneumonia surveillance. Special definitions apply for

the surveillance of pneumonia caused by aspergilli or legionella.

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3. Requirements for participation in ONKO-KISS by

hematology/oncology units and duties of KISS institutions

Participating facilities must fulfill the following requirements:

Treatment of at least 20 patients with bone marrow or blood stem cell

transplantations annually (for ONKO-KISS_AL, at least 20 patients with AML or ALL

must be treated with chemotherapy annually)

Written agreement of ward head to KISS participation and to data transfer via

webKess

Employment of full-time infection control personnel or hygiene specialists by the

participating hospital. Infection control personnel are the most important contact

partners for ONKO-KISS and are responsible for organizing surveillance in the

participating departments and wards.

Registration of participation with the IUK Freiburg

Participation in an introductory course in surveillance by the IUK. A date for the

introductory course will be made with each new participant before the start of

surveillance.

Registration for webKess by the participating ward

Regular transfer of collected data to the NRZ via webKess

Readiness of infection control personnel to participate in validation measures in HAI

diagnosis; e.g. during the annual ONKO-KISS participant meeting in Freiburg

Readiness to employ appropriate internal quality assurance measures upon relevant

surveillance results

Agreement to use the fixed definitions given here for HAI diagnosis and agreement to

inform attending physicians

Strict use of the specifications found in this protocol and readiness to discuss open

questions. In addition to those data required by this protocol, participating

departments are free to include other data that are relevant for quality management.

The NRZ promises participating departments to:

Provide advice and expert support during surveillance

Handle each ward’s data strictly confidentially

Send standardized infection data as reference data to participant yearly

Advise them on the implementation of surveillance results for quality management

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4. Methods

4.1 Patient data collection

All patients who receive a bone marrow transplantation (BMT) or peripheral blood stem

cell transplantation (PBSCT) or a cord blood transplantation should be kept under

surveillance during the neutropenic phase.

The following applies for ONKO-KISS_AL: all patients who are treated with

chemotherapy for acute leukemia are included in surveillance during the neutropenic

phase.

A patient data collection form must be completed for all neutropenic patients

Basic data for each patient should be documented, such as name, birthdate, sex, date of

admission or transfer, start and end of neutropenic phase or phases, illness (if

applicable), type of transplantation (or phase of chemotherapy for ONKO-KISS_AL) and

type of venous access, as well as any length of stay in intensive care.

If a central venous catheter is present, additional information about its location and type

as well as about the use of remanent skin disinfectant and/or patches should be included.

4.2 Infection data collection

Surveillance should take place during the neutropenic phase. During the neutropenic

phase, all healthcare-associated bloodstream infections and pneumonias should be

recorded in the patient data collection form. For each recorded case of pneumonia, a

special infection data collection form should be completed with information about

diagnosis.

4.3 Calculation of reference data

The following infection rates are calculated (incidence density: total number of cases in

reference to 1000 neutropenia-days):

Bloodstream infection rate:

Total BSI

———————x1000

Neutropenia-days

Pneumonia infection rate:

Total cases of pneumonia

———————x1000

Neutropenia-days

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Starting in 2011, the infection rates for BSI and pneumonia per 100 patients have been

available publicly online. Until then, the rates had only been available to ONKO-KISS

participants.

4.4 Comparing infection rates

Standardized infection rates are calculated by the NRZ with the collected data of all

participating departments and made available as reference data. These figures are available

online on the NRZ web site. The infection rates of each specific ward are kept confidential

and transferred only to that ward.

The reference data make it possible to benchmark one’s own data against the pooled data of

all participating departments. However, comparison is only possible when all factors are

taken into account. This comparison is only possible when other relevant factors are taken

into account. However, the Institute for Environmental Medicine and Hospital Hygiene

provides an aid for reference data interpretation.

Changes in infection rates on one station may be observed over time and may point to

infection control issues that should be investigated further. Starting in 2011, participants have

been provided with a “smoothed curve” once per year via webKess in order to better

recognize changes in the course of surveillance.

Surveillance results must be presented yearly to the wards or departments in which

surveillance has taken place.

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5 General definition principles by the CDC and specified definitions

A diagnosis of infection for the purpose of surveillance relies on a combination of clinical

symptoms, and laboratory and other supporting data (e.g., X-rays, microbiological evidence),

weighted differently according to the type of infection.

An infection is defined as healthcare associated when it was not apparent or in the

incubation stage at admission.

HAI can be caused by endogenous or exogenous pathogens.

A colonization (presence of disease agents on skin or mucous membranes, in open

wounds, in excretion or secretion) is not an infection.

It is important to note that these epidemiological definitions are not intended for day-to-day

infection diagnosis by attending physicians, but instead for HAI surveillance. The definitions

should make it possible for infection control personnel to recognize a HAI based on patient

records. They provide a structure into which patients can be classified in order to provide the

best possible comparison between departments or wards.

These definitions are not appropriate for making decisions about treatment or therapy.

Specific definitions for ONKO-KISS

During surveillance of the neutropenic phase, as is analogous to CDC criteria, BSI and

pneumonia are only recorded when they were not apparent or in incubation at the start of

neutropenia.

BSI surveillance:

CDC definitions apply. Because nearly all neutropenic patients have a CVC of one type or

another, healthcare-associated BSIs are per se defined as associated with devices.

It is characteristic in neutropenic patients who have received a bone marrow or blood stem

cell transplantation that blood cultures are negative because of early antibiotic therapy. In

order to assure simple classification, only laboratory-confirmed BSIs according to CDC

criteria are considered HAIs.

Pneumonia surveillance:

The modified criteria for immune-suppressed patients by Carlisle, P., et. al. (1993) apply for

healthcare-associated pneumonia surveillance.1 These were also the basis for a four-year

surveillance period (1997 to 2001) of HAI in the Inner Medicine I (Hematology, Oncology)

ward of the University Clinic Freiburg.2 A multi-year pilot phase within ONKO-KISS showed

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that the CDC definitions for healthcare-associated pneumonia in immune-suppressed

patients are not appropriate for surveillance within ONKO-KISS. At the same time, the

appropriateness of Carlisle’s definitions has been confirmed.

Special definitions for pneumonia caused by fungus or Legionella have been in use since

2004 because these types of pneumonia could not be recorded with the above-named

criteria (Carlisle).

The definition for pneumonia was adjusted in order to include pneumonia caused by fungus

in 2010 following EORTC criteria for the definitions of invasive fungal infections (De Pauw et

al, Clin Infect Dis 2008; 46:1813-21).

The definition for pneumonia caused by Legionella is the CDC definition for atypical

pneumonia in patients with immunodeficiency or suppression.

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6 Definitions

Following the Guidelines of the Infectious Diseases Society of America (IDSA) from

19973, the definition for neutropenia is:

a neutrophil count of <500 cells/mm3, or a count of <1000 cells/mm3 with a predicted

decrease to <500 cells/mm3

or:

total leucocytes < 1000/mm3.

The neutropenic phase is ended when a patient has not been neutropenic according to

the above definition for three consecutive days (for examples, see 9.1).

6.1 Primary Bloodstream Infection (BSI)

Laboratory confirmed BSI has to fulfill at least one of the following criteria:

Either:

1. Patient has a recognized pathogen* cultured from 1 or more blood cultures and organism

cultured from blood is not related to an infection at another site. Catheter-associated BSI is

classified as a primary BSI also when there are signs of infection at the site of insertion.

and/or:

2. One of the following: fever (>38oC, rectal or oral), chills, or hypotension

and one of the following:

Common skin contaminant** is cultured from 2 or more blood cultures drawn on

separate occasions and signs and symptoms and positive laboratory results are not

related to an infection at another site.

Positive blood test for antibodies and the pathogen is not related to an infection at

another site.

* Evidence of Aspergillus spp. is always considered contamination.

**Diphtheroids [Corynebacterium spp], Propionibacterium spp, coagulase-negative

staphylococci [including S epidermidis], etc.

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6.2 Pneumonia

Pnuemonia in immune-suppressed patients

must fulfill one of the following criteria.

Either:

Fever (>380C, measured rectally or orally) and new or progressive and persistent infiltrate in

radiological diagnosis*

and/or:

at least two of the following:

Sputum production

Coughing

Dyspnea

Rhoncus or crackling sounds

Leukocytes in sputum microscopy

Pleural rub

*I.e., a radiologically proven infiltrate that does not appear in a second examination (with a

multi-day interval) is not adequate.

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6.2.1 Definitions for fungal pneumonia and Legionella pneumonia

(Legionnaire’s disease)

Definition of fungal pneumonia

Demonstrated opportunistic fungal pneumonia

Histo/cytopathology: Hyphae in needle aspiration/biopsy material (not mucous membrane) +

damage to tissue (microscopy or imaging)

or

Blood culture: Fungus from tissue/biopsy materials from primarily sterile body parts with

evidence indicating pneumonia

NOT: Bronchoalveolar lavage (BAL); NOT: Evidence of Aspergillus spp. in blood cultures

Probable opportunistic fungal pneumonia

At least one of the following patient characteristics:

Current or recent neutropenia (< neutrophils/mm3) for >10 days

Status post allogeneic BSCT

Corticosteroid > 3 weeks (average dose 0.3 mg/kg/d prednisone equivalent) with the

exception of patients with allergic bronchopulmonary aspergillosis.

Treatment with further T-cell immune suppressants (e.g., Cyclosporin, TNF- blocker,

specific monoclonal antibodies, nucleoside analogues) within the last 90 days

Severe congenital immunodeficiency

And

At least one of the follow mycological findings

Direct evidence: Evidence of fungus in respiratory secretion (Sputum, BAL, brush

biopsy) by

Fungus culture (Aspergillus, Fusarium, Mucor, Absidia, Rhizopus spp., etc)

Evidence of fungus components indicating fungal infestation

Indirect evidence:

Positive evidence of aspergillus antibodies (Galalctomannan-AG) from BAL,

plasma or serum

And

At least one of the following findings in thoracic CT: (consistent with mycological

findings and in a temporal relationship to the course of infection):

Thick nodules with or without halos

Air crescents

Cavity development

Modified according to EORTC criteria for invasive fungal infections (De Pauw, et al., Clin

Infect Dis 2008; 46: 1813-21)

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Definition of Legionella pneumonia (Legionnaire’s disease)

At least one of the following signs is found in two or more thoracic X-rays (In patients

without underlying pulmonary or cardiac disease (e.g., respiratory distress syndrome,

bronchopulmonary dysplasia, pulmonary edema, or chronic obstructive pulmonary disease),

one definitive chest radiograph is acceptable):

New or progressive and persistent infiltrate

Consolidation

Cavity development

Pneumatoceles, in infants <1 year old

and at least one of the following:

Fever (>38C) with no other recognized cause

For adults >70 years old, altered mental status with no other recognized cause

New onset of purulent sputum

or change in character of sputum (color, consistency,

smell)

or increased respiratory secretions or increased suctioning requirements

New onset or worsening cough or dyspnea or tachypnea

Rales

or bronchial breath sounds

Worsening gas exchange (increased oxygen requirements, or increased ventilator

demand)

Hemoptysis

Pleural pain

and at least one of the following:

Cultured evidence or micro-immunofluoresence (IF test) for Legionelle spp. from

respiratory tract secretion or tissue

Evidence of L. pneumophila SG1 antigens in urine

Quadrupling of L. pneumophila antibody titer to >1:128 in serial serum tests

Source: CDC definitions for pneumonia in immunocompromised patients, specified for

Legionella pneumonia (Legionnaire’s disease)

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7. Surveillance specifications

7.1 Patient data collection forms for ONKO-KISS, ONKO-KISS_PAED and

ONKO-KISS_AL

Participants submit their ONKO-KISS data for evaluation via webKess. In order to enter their data,

participants must register for webKess with the NRZ in Berlin. An abbreviation for the hospital will be

provided by the NRZ.

Each module (ONKO-KISS, ONKO-KISS_PAED and ONKO-KISS_AL) must be registered separately.

Written registration at the NRZ in Berlin with consent of the appropriate ward is the final step.

The Internet address of webKess is www.webKess.de.

Online problems can be resolved by calling the NRZ at 030 450 570022 or by writing an email to kiss-

[email protected].

Reference data are prepared once per year by the NRZ in Berlin. In order to make sure the reference

data reflect the most recent surveillance, ONKO-KISS participants are required to complete their

surveillance data from one calendar year within the first six weeks of the next year.

The definition of a BSI for surveillance changed in 2011. Previously, it was possible to record a case of

BSI with a single culture of skin flora. Because of this substantial change, reference data were cut off

at the end of 2010 and restarted in January 2011. Data can only be evaluated before 2010 or after

2011.

Participants can evaluate their own data at any time in webKess.

Advice on surveillance for individual cases is available from the IUK in Freiburg.

Data should be recorded on the collection form and transferred to webKess when the patient is

discharged. The system automatically gives each patient an ID that should be noted on the chart in

order to clearly attribute the data.

Patients can be under surveillance in multiple wards, but the NRZ only evaluates hospitals as a whole.

After consulting with the NRZ, it is possible for hospitals with more than one participating ward to

receive separate abbreviations.

Sex, age and underlying disease are collected as master data.

Type of venous access is also recorded.

If two kinds of venous access are present, only the most risky in relation to infections is

recorded. Usually, the risk of infection is lowest with a PVC, followed by ports, Hickman

catheters and CVCs.

If a patient has a CVC, the site of the CVC is also recorded, and if the CVC is coated (with

silver or antibiotics) or not. In addition, the use of remanent skin disinfectants during the

installation or maintenance of the venous access is also documented. Octenidin (Octeniderm,

Octenisept) and Chlorhexidin (Skinsept F) have remenence effects. The use of patches or

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bandages with remanent active ingredients (e.g., Biopatch or Tegaderm CHG/Chlorhexidin) is

also recorded.

Surveillance is performed during the neutropenic phase or phases.

The beginning and ending of all neutropenic phases is documented, as is if the patient was

neutropenic at admission to the ward.

The number of neutrophils or the total number of leukocytes measured at a set time (e.g. 7 a.m.)

is recorded.

Neutropenia (neutrophil count of <500 cells/mm3 or total leucocytes < 1000/mm

3) must be present

for two consecutive days to begin the neutropenic phase. The neutropenic phase is ended as

soon as the neutrophil count is >500 cells/mm3 or total leucocytes > 1000/mm

3 for three

consecutive days.

If a patient is no longer neutropenic for one or maximum two consecutive days during a

neutropenic phase, then these days are counted as neutropenia-days (see 8.4 for examples).

Because some patients develop multiple neutropenic phases, patients must be kept under

surveillance regarding their neutrophil or total leukocyte counts until they are transferred or

discharged.

The reason for ending surveillance is also documented: end of neutropenic phase, transfer or

discharge of patient while neutropenic, or death of patient.

If a patient was on an ICU during the neutropenic phase and if he or she was ventilated by

intubation should be recorded. Days in intensive care are counted as neutropenia-days and HAIs

appearing there should be recorded.

Quinolone prophylaxis (with Levofloxacin or Ciprofloxacin, for example) should be recorded if

performed. A “Yes” for prophylaxis means that quinolone was given BEFORE the start of fever

and BEFORE the first therapeutic antibiotics. Information must also be provided if quinolone

prophylaxis is NOT performed: either this is appropriate for a patient’s prophylactic regime or the

patient is already on antibiotics.

Infection surveillance

Infections are to be documented after the second day of the neutropenic phase; infections are to

be documented up to and including the second day after the neutropenic phase (see 8.4 for

examples).

When a BSI or pneumonia appears during the neutropenic phase, the data of the infection and the

proven pathogen are both recorded. Up to 4 pathogens can be recorded per infection. The

pathogens are listed in order of presumed etiological relevance.

Specifications for BSI surveillance

The start date for a BSI is the date on which the blood culture was taken. If the same pathogen is

found more than once, then only one case of BSI is recorded. If a different pathogen is found in a later

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culture, that does not automatically mean that a second case of BSI is present. A second case is only

recorded if the previous BSI had already ended.

BSIs are ended when all infection parameters are within normal limits and the patient has been

clinically stable for three days, independent of whether antibiotic therapy has ended or not.

Coagulase-negative staphyloccci, corynebacteria and propionbacteria are considered skin

contaminants; Streptococcus mitis is considered a disease agent.

According to current CDC definitions, BSIs in which only a skin contaminant and not a disease agent

are found should only be included in surveillance when the pathogen was found in at least two blood

cultures taken separately.

Aspergilla are always considered contamination.

Specifications for pneumonia surveillance

The start date for pneumonia is that on which the first specific sign of pneumonia appeared. The

following signs apply as specific for pneumonia: sputum production, cough, rhoncus or crackling

sounds, leukocytes in sputum microscopy and pleural rub, as well as an X-ray or CT examination with

indications for pneumonia. Fever and dyspnea are not signs specific to pneumonia.

Pneumonia may be included in surveillance in three different ways:

Variant 1

Surveillance by fever and two verifications by X-ray or CT (without a time restriction between the

first and second verification). If the first verification is an examination with the suspicion of pneumonia

and is confirmed later, then the first verification is considered a positive verification.

Fever and one positive X-ray exam must be present at the same time (within a period of three days).

Variant 2

Surveillance by clinical signs and symptoms

If surveillance should take place based only on clinical signs and symptoms (not including fever or

dyspnoe), then at least two of these must be present for at least three days. Clinical signs include:

sputum production, cough, rhoncus or cracklings ounds, leukocytes in sputum microscopy and pleural

rub. In these (rare) cases, pneumonia can only be recorded if the patient was not X-rayed. If there is a

negative x-ray or CT result available, the infection is not considered pneumonia.

Varient 3 (most common case)

Surveillance by fever, one verification by X-ray and CT and two clinical signs or symptoms

The clinical signs or symptoms for pneumonia must present simultaneously for at most ten days.

Clinical signs include: Dyspnoe, sputum production, cough, rhoncus or crackling sounds, leukocytes in

sputum microscopy and pleural rub. In the same time period, fever must be present once and a

positive X-ray result must be available.

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Whether the radiological verification took place by X-ray or by CT must be recorded.

If patient material was examined microbiologically and if a pathogen could be confirmed in this

way must be recorded.

Because the definitions for pneumonia surveillance, especially those for fungal pneumonia or

Legionella pneumonia (Legionnaire’s disease), are rather difficult to implement, all definition

criteria are asked about for all cases of pneumonia. In this way, it is possible to see which criteria

were important in making the diagnosis. A special form for each kind of pneumonia (normal,

fungal, Legionella) is available in webKess.

After the neutropenic phase

Infection surveillance ends after the end of the neutropenic phase.

Patients are observed in regard to further neutropenic phases until the end of their stay on the

ONKO-KISS ward.

The reason for ending surveillance (discharge, transfer, or death) must also be documented.

After the end of surveillance, patient data is entered by the participants into webKess.

General specifications

Facilities new to ONKO-KISS have the opportunity to record only BSI for a certain period,

upon approval by the project headquarters in Freiburg. The prerequisite is that the relevant

data are being recorded on the ward.

We recommend performing surveillance once or twice a week.

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7.1.1 ONKO-KISS and ONKO-KISS_PAED

Those patients who have received bone marrow transplantation (BMT) or peripheral blood stem

cell transplantation (PBSCT) or cord blood transplantation on the participating ward are included in

surveillance. Only children with allogeneic transplants are included in ONKO-KISS_PAED. ONKO-

KISS includes patients older than 16; ONKO-KISS_PAED includes all children under 16 and those

young adults still being treated in pediatrics.

ONKO-KISS and ONKO-KISS_PAED data are collected and evaluated in separate databanks.

A unique ID number is assigned to each patient data form when the data is entered into webKess.

This number should be noted on the form in order to correctly correlate the data to the patient.

Patient data forms remain with participants.

If two underlying illnesses are both present, enter the illness for which the transplantation or

transplantation is relevant. If this is not possible, check AND.

Both the degree of illness and the type of transplantation or transplantation are recorded.

“Early stage” includes all patients with complete remission of their illness, all patients who

received transplantation directly after their diagnosis, and all CML patients in the first chronic

stage. “Late stage” includes all relapsed patients, patient in second remission or the second

chronic phase, or in any further stage, e.g. second or third recidivism.

If a patient receives transplantation twice during the same stay in the participating ward, only one

data collection form is filled out, and the more invasive procedure is recorded. If a patient receives

multiple transplantations and is transferred out of the participating ward and back again, then a

new data collection form should be filled out for each transplantation.

Patients are recorded by the hospital where they receive transplantations and not in other

hospitals they were in for staging or chemotherapy, even when the patients may have been

neutropenic.

7.1.2 Specifications for ONKO-KISS_AL (for acute leukemia)

All patients over 16 years of age with acute leukemia (AML and ALL) that have not received a

primary transplantation and have been treated with chemotherapy are to be included in

surveillance. Relapsed patients who received allogeneic transplantations prior to current

treatment are not included. Patients receiving special treatment (experimental or palliative, for

example) are not included.

All types of acute leukemia listed under 8.3 in the ICD-10 codes are included. Other types may be

included upon approval from the IUK.

It is possible to include only AML patients and not track patients with ALL.

ONKO-KISS_AL data are entered into a separate databank and evaluated separately. AML and

ALL patients are also evaluated separately. Data are also evaluated by therapy group.

A data collection form should be completed for each neutropenic phase.

Because the risk of infection increases with each (successive) neutropenic phase, how many

times the patient has already been neutropenic is also recorded. The phases should be numbered

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chronologically, and the number of the phase should be noted. In this way it is possible to evaluate

in which neutropenic phase a patient developed an infection. Because this information is very

important, it must be determined when a patient’s medical history is taken if and how many times

he or she has already been neutropenic. Neutropenic phases are counted starting once leukemia

has been diagnosed. If the course of sickness is unknown because of stays in other hospitals,

then it is necessary and important to ask the previously attending physicians about the number of

prior cycles or to determine this information from referral letters. Every cycle of neutropenia is

should be given a new number. This information must not be collected about patients being

treated with a relapse protocol.

The phases of treatment are classified in the following table:

Chemotherapy phase Therapy block No.

Preliminary phase 0

Induction 1 1

Induction 2 2

Reinduction 1 3

Reinduction 2 4

Consolidation 1 5

Consolidation 2 6

Consolidation 3 7

Consoldiation 4 8

Consolidation 5 9

Induction 1 and 2 10

Reinduction 1 and 2 11

Consolidation 1 and 2 12

Consolidation 6 13

Consolidation 7 14

Preliminary phase and induction 1 15

Induction 3 16

Preliminary phase, induction 1 and 2 17

Induction, phase unknown (1, 2, or 1 and 2) 18

Patients are divided into four therapy groups by the type of chemotherapy given for the purpose of

risk stratification when the data are evaluated twice yearly.

Standard therapy

Expanded therapy

Relapse therapy

Therapy for patients >60

The therapy block numbers (from the above table) are sorted into the therapy groups “standard

therapy” and “expanded therapy” as follows.

Therapy groups (AML) Therapy block no.

Standard therapy 0, 1, 2, 5, 10, 15, 17, 18 Expanded therapy 3, 4, 6, 7, 8, 9, 11, 12, 13, 14, 16 Relapse therapy Patients >60

Therapy groups (ALL) Therapy block no.

Standard therapy 0, 1, 2, 3, 4, 5, 6, 10, 11, 12, 15, 17, 18

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Expanded therapy 7, 8, 9, 13, 14, 16 Relapse therapy Patients > 60

Patients being treated according to a relapse therapy plan are not sorted into therapy groups. Only

the fact that the patients are being treated by a relapse therapy plan is noted.

Patients 61 and older are also not sorted into therapy groups. As with patients in relapse therapy,

this group is evaluated separately.

Patients in relapse therapy and patients 61 and over should still be classified by therapy block,

although they are not included in “standard” or “expanded” therapy groups.

The specific type of therapy undergone by a patient is not recorded on the patient information form

or in webKess.

Instead, participating departments are required to answer an annual questionnaire about by which

kinds of therapy their AML and ALL patients receive.

7.2 Patient progress form

The patient progress form has been developed as an aid to HAI surveillance. Fevers, microbiological

or radiological evidence and changes to antibiotic therapy can be noted here when patient records are

examined, in order to ease the diagnosis of healthcare-associated BSI or pneumonia.

Questions about the pneumonia or BSI diagnosis can be directed to the IUK.

7.3 BSI pathogen resistance surveillance

The resistograms of proven BSI disease agents (all pathogens except skin contaminants) should be

sent upon their appearance per fax to the IUK in Freiburg.

The resistograms must be clearly identified with ONKO-KISS hospital abbreviation, the module and

the patient’s webKessID.

These data are collect in a databank and evaluated.

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8. Documentation specifications

8.1 Patient information form

Hospital abbreviation Assigned by the NRZ upon registration for webKess. If the hospital

already has an abbreviation because of participation in another module,

it will be used further.

Patient ID Automatically assigned during data entry.

Underlying illness See 8.2 for list of abbreviations of underlying illnesses

Transplantation Sygenic transplantation is considered “ allogeneic/related” for the

purposes of surveillance.

Pathogen See 8.4 for list of pathogen abbreviations

ICD-10 codes for ONKO-

KISS_AL

See 8.3 for list of acute leukemias

8.2 Abbreviations of underlying illnesses

Acute myeloid leukemia AML

Chronic myeloid leukemia CML

Acute lymphoblastic

leukemia

ALL

Non-Hodgkin’s lymphoma NHL

Myelodysplastic syndrome MDS

Plasma cell myeloma PLAS

All other illnesses AND

8.3 ICD-10 codes for acute leukemias

C91.0 C91.5 C91.7 C91.9

C92.0 C92.2 C92.4 C92.5 C92.7 (following consultation) C92.9

C93.0 C93.2 C93.7 C93.9

C94.2 C94.3 C94.7

C95.0 C95.2 C95.7 C95.8 C95.9

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8.4 Pathogen abbreviations

Please differentiate as exactly as possible. For technical reasons, the abbreviations have been left in

the German original and may seem unrelated to the English name of the pathogen.

Pathogen Pathogen group

No growth KW KW

Gram-positive pathogens

Other gram-positive pathogens APS GPST

Other cocci ANK ANK

Bacillus spp. BAL GPST

Cornebacterium spp. COR GPST

Enterococci ENT ENT

Enterococcus faecalis ÊFIS ENT

Enterococcus faecium EFUM ENT

Vancomycin-resistant Enterococcus VRE VRE

Vancomycin-resistant Enterococcus faecalis VFIS VRE

Vancomycin-resistant Enterococcus faecium VFUM VRE

Coagulase-negative Staphylococcus KNS KNS

Staphylococcus epidermidis SEPI KNS

Staphylococcus haemolyticus SHAE KNS

Staphylococcus hominis SHOM KNS

Staphylococcus lugdunensis SLUG KNS

Micrococci MIK ANK

Nocardia NOC GPST

Propionibacterium PPB GPST

Staphylococcus aureus SAU SAU

Methicillin-resistant Staphylococcus aureus MRSA MRSA

Streptococci STR STR

Group A Streptococci STRA STR

Group B Streptococci STRB STR

Streptococcus equismilis (C and G) STRE STR

Streptococcus mitis STRM STR

Streptococcus pneumonia STRP STR

Viridan streptococcus STRV STR

Gram-negative pathogens

Other gram-negative pathogens AGNE AGNE

Acinetobacter spp. ACI ACI

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Other enterobacteria AEN AEN

Other gram-negative bacilli ANS ANS

Other gram-negative ESBL bacilli ANS_ESBL ANS_ESBL

Other gram-negative MBL bacilli* ANS_MBL ANS_MBL

Other non-fermenter ANO ANO

Bacteroides spp. BAC BAC

Burkholderia cepacia BCE BCE

Citrobacter spp. CIT CIT

Citrobacter spp., ESBL CIT_ESBL CIT_ESBL

Citrobacter spp., MBL* CIT_MBL CIT_MBL

Enterobacter spp. ENB ENB

Enterobacter spp., ESBL ENB_ESBL ENB_ESBL

Enterobacter spp., MBL* ENB_MBL ENB_MBL

Escherichia coli ECO ECO

Escherichia coli, ESBL ECO_ESBL ECO_ESBL

Escherichia coli, MBL* ECO_MBL ECO_MBL

Haemophilus spp. HAE HAE

Klebsiella spp. KLE KLE

Klebsiella spp., ESBL KLE_ESBL KLE_ESBL

Klebsiella spp., MBL* KLE_MBL KLE_MBL

Moraxella catarrhalis MOR MOR

Neisseria spp. NEI NEI

Proteus spp. PRO PRO

Proteus spp., ESBL PRO_ESBL PRO_ESBL

Proteus spp., MBL* PRO_MBL PRO_MBL

Pseudomonas aeruginosa PAE PAE

Pseudomonas aeruginosa, MBL* PAE_MBL PAE_MBL

Serratia spp. SER SER

Serratia spp., ESBL SER_ESBL SER_ESBL

Serratia spp., MBL SER_MBL SER_MBL

Stenotrophomonas maltophilia STM STM

Always include resistance to ESBL!

*Metallo-betalactamase- and carbapenemase-producing pathogens are included in the abbreviation

MBL.

Pathogen Pathogen group

Other pathogens

Other anaerobes ANA ANA

Atypical mycobacteria AMY AMY

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Atypical pneumonia pathogens

Chlamydia spp. CHL CHL

Legionella spp. LEG LEG

Legionella antigens LEG_AG ÖEG

Legionella antibodies LEG_AK LEG

Mycoplasma MPL MPL

Fungi

Aspergillus spp. ASP ASP

Aspergillus antibodies ASP_AG ASP

Aspergillus flavus AFL ASP

Aspergillus fumigates ASF ASP

Aspergillus nidulans ANI ASP

Aspergillus niger ASN ASP

Aspergillus terreus ATE ASP

Candida spp. ANC ANC

Candida albicans CAN ANC

Candida glabrata CGLA ANC

Candida krusei CKRU ANC

Candida parapsilosis CPAR ANC

Candida tropicalis CTRO ANC

Candida guiellermondi CGUI ANC

Candida kefi CKEF ANC

Candida norvegensis CNOR ANC

Candida inconspicua CINC ANC

Hyphae or other parts of fungus* HYPH SCH

Acremonium spp. ACRE SCH

Absidia spp. ABS SCH

Exophiala spp. EXO SCH

Fusarium spp. FUS SCH

Mucor spp. MUC SCH

Penicillium spp. PEN SCH

Pseudoallescheria spp. PSE SCH

Rhizopus spp. RHI SCH

Sedosporium spp. SED SCH

Other funguss SPA SCH

Cryptococcus spp. CRY HEF

Geotrichum spp. GEO HEF

Trichosporon TRI HEF

Other yeasts HPA HEF

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Pneumocystis jirovecii PCC PCC

Other fungi ANP ANP

*for fungal pneumonia surveillance

Viruses

Adenovirus ADV ADV

Other viruses ANV ANV

Cytomegalie virus CMV CMV

Enterovirus ENV ENV

Human metapneumovirus HMV HMV

Herpes simplex HSV HSV

Influenza / parainfluenza INV INV

Respiratory syncytial virus RSV RSV

Rhinovirus RHV RHV

Pathogens are presented in the evaluation summarized in groups.

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8.5 Examples for determining neutropenia as a surveillance period

(In these examples, L= total leukocytes per mm3. In reference to neutrophil granulocytes, the

relevant limit value is 500/mm3.)

1.

In this case, the patient is considered continuously neutropenic, because the leukocyte count was

>1000/ mm3 for only two consecutive days rather than three, as required. As a result, 7 neutropenia-

days are recorded. Infections are recorded from day 2.

2.

In this case, the patient is considered neutropenic starting on day 5 because the leukocyte count was

< 1000 mm3 for only one day (on day 2) and not for two consecutive days, as required. Three

neutropenia-days are recorded from day 5. Infections are recorded from day 6.

3.

In this case, the patient is considered neutropenic starting on day two because the leukocyte count

was < 1000 mm3 on two consecutive days. Day 4 is also considered a neutropenia day because the

leukocyte count was not >1000 mm3 for three consecutive days, as required. 6 neutropenia-days are

recorded, and infections are recorded from day 3.

4.

In this case, the patient is considered neutropenic until day 3. The patient is no longer neutropenic

from day 4. As a result, 3 neutropenia-days are recorded. Infections are recorded from day 2 to day 5.

Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7

200 L 600 L 1000 L 1200 L 1200 L 800 L 400 L


1400 L 800 L 1200 L 1100 L 600 L 200 L 100 L


1400 L 800 L 1000 L 1100 L 600 L 200L 100L


200 L 800 L 1000 L 1100 L 1800 L 2600 L 5400 L

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5.

In this case, the patient is considered from day 3 to 5 not neutropenic and neutropenic on days 1 and

2 and from day 6. Days 3 to 5 are not counted as neutropenia-days, and 4 neutropenia-days are

recorded for the patient. Infections are recorded from day 2 to 4 (including day 4) and from day 7.

Infections appearing on days 5 and 6 are not recorded.

This situation is highly unlikely and has been presented here only for the sake of completeness.

More likely is a situation in which a patient is neutropenic in two clearly different phases.

A final example:

6.


200 L 800 L 1000 L 1500 L 2100 L 4500 L 6200 L


5200 L 5800 L 5200 L 3500 L 1800 L 800 L 200 L

The first phase of neutropenia lasts until day 3. The second phase starts on day 13. The neutropenia-

days of both phases are counted together, with the result of 5 neutropenia-days for the patient.

Infections are recorded from day 2 to day 5 and from day 14. Infections that appear between day 6

and day 13 are not recorded.


200 L 800 L 1200 L 1500 L 1100 L 800 L 200 L

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9 References

1. Carlisle P et al.: Nosocomial infections in neutropenic cancer patients, Infect Control

Hosp Epidemiol 1993, 6: 320-324

2. Dettenkofer M et al.: Nosokomiale Infektionen bei neutropenischen Patienten auf einer

KMT-Station, 4. Berliner Workshop: Nosokomiale Infektionen bei

immunsupprimierten Patienten, Berlin 2000

3. Dettenkofer M, Ebner W, Bertz H et al.: Surveillance of Nosocomial Infections in Adult

Recipients of Allogeneic and Autologous Bone Marrow and Peripheral Blood

Stem-Cell Transplantation. Bone Marrow Transplantation 2003; 31:795-801

4. Dettenkofer M, Wenzler-Röttele S, Babikir R, Bertz H, Ebner W, Meyer E, Rüden H,

Gastmeier P, Daschner F D: Surveillance of nosocomial sepsis and pneumonia in

patients with a bone marrow or peripheral blood stem cell transplantation. A

multicenter project. Clin Infect Dis 40, 926-931, 2005

5. Laws H J, Kobbe G, Dilloo D, Dettenkofer M, Meisel R, Geisel R, Haas R, Gobel U,

Schulze-Robbecke R: Surveillance of nosocomial infections in paediatric

recipients of bone marrow or peripheral blood stem cell transplantation during

neutropenia, compared with adult recipients. J Hosp Infect Oct 18, 2005

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10 Appendix

10.1 Patient data collection form for ONKO-KISS and ONKO-KISS_PAED: Patients with bone marrow or blood stem cell transplantations (BMT, PBSCT, cord blood) Last name: First name:

Birthdate: Date of admission:

Hospital: webKess ID: Gender f m Birth year:

1st

Neutropenic phase: from (date) ____________ to _______________

2nd

Neutropenic phase: from (date) ____________ to _______________

Patient was neutropenic upon admission to ward: Yes No

Surveillance ended by: end of neutropenic phase transfer/discharge death

Basic illness AML CML ALL NHL MDS PLAS AND

Current stage Early Late

Transplantation KMT PBSCT Cord blood

autologous autologous

allogeneic, related allogeneic, related allogeneic, related

allogeneic, unrelated allogeneic, unrelated allogeneic, unrelated

Quinolone prophylaxis (i.e., Levofloxacin or Ciprofloxacin) Yes No

If no, why? No routine quinolone prophylaxis Quinolone prophylaxis is

routine, but patient already under antibiotic

Type of access CVC Hickman Port No central access

If CVC: Site of access? Jugular Subclavian Other type

Type of CVC? Uncoated Coated (silver) Coated (anti-infective)

Use of skin disinfectants with remanence effects? Yes No

If Yes: Octenidin Chlorhexidin other_____________

Upon CVC insertion: Yes No unknown

For catheter care: Yes No unknown

Use of patches/bandages with remanence effects? Yes No

If Yes: Biopatch Tegaderm CHG/Chlorhexidin other ____________

Patient in ICU No Yes from (date) _______________ ventilated? Yes No

BSI: Yes No

Date: ___________ Pathogen: ________

Pneumonia: Yes No

Date: ___________ Microbiological examination of sample? Yes No

Pathogen: ________ Found in ________________

Version 06_2011

Institute for Environmental Medicine and Hospital Hygiene, University Clinic Freiburg

National Reference Center for Surveillance of Nosocomial Infections, Berlin

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10.2 Patient data collection form for ONKO-KISS_AL: Patients with AML or ALL

without primary transplantation and receiving standard chemotherapy

Last name: First name:

Birthdate: Date of admission:

Hospital: webKess ID: Gender f m Birth year:

Current stay:

Neutropenic phase No.: ______ from (date) ________ to (including) ____________

Patient was neutropenic upon admission to ward: Yes No

Surveillance ended by: end of neutropenic phase transfer/discharge death

Basic illness AML ALL

Current stage Early Late

Chemotherapy Phase __________________________ (see surveillance protocol)

Quinolone prophylaxis (i.e., Levofloxacin or Ciprofloxacin) Yes No

If no, why? No routine quinolone prophylaxis Quinolone prophylaxis

is routine, but patient already under antibiotic

Type of access CVC Hickman Port No central access

If CVC: Site of access? Jugular Subclavian Other type

Type of CVC? Uncoated Coated (silver) Coated (anti-infective)

Use of skin disinfectants with remanence effects? Yes No

If Yes: Octenidin Chlorhexidin other_____________

Upon CVC insertion: Yes No unknown

For catheter care: Yes No unknown

Use of patches/bandages with remanence effects? Yes No

If Yes: Biopatch Tegaderm CHG/Chlorhexidin other ____________

Patient in ICU No Yes from (date) _______________ ventilated? Yes No

BSI: Yes No

Date: ___________ Pathogen: ________

Pneumonia: Yes No

Date: ___________ Microbiological examination of sample? Yes No

Pathogen: ________ Found in ________________

Version 06_2011



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10.3 Data collection forms for pneumonia

Data collection form for normal pneumonia

Patient ONKO-KISS ID: _________________________

Diagnosis criteria (fill out for each case of pneumonia registered)

Evidence from single X-ray Yes No

Evidence from multiple X-rays Yes No

Evidence from single CT Yes No

Evidence from multiple CT Yes No

Fever > 38oC Yes No

Sputum Yes No

Coughing Yes No

Dyspnea Yes No

Crackling sounds Yes No

Pleural rub Yes No

Version 06_2010



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Data collection form for Fungal Pneumonia

Patient ONKO-KISS ID: ______________________________

Demonstrated invasive fungal pneumonia

Histo/Zytopathology: (Proof of hyphae in tissue): Yes No

Culture of tissue from primarily sterile body sites: Yes No

Probable invasive fungal pneumonia

At least one of the following patient characteristics

Neutropenia > 10 days Yes No

Post status PBSCT or BMT: Yes No

Corticosteroid treatment > 3 weeks Yes No

T-cell immunosuppressive medication Yes No

Congenital immunodeficiency Yes No

At least one of the following mycological findings

Culture evidence of fungus Yes No

HYPH Evidence of fungal parts Yes No

ASP_AG Positive evidence of aspergillus AG in BAL or serum Yes No

At least one of the following findings in thoracic CT

Thick nodules with or without halos Yes No

Air crescents Yes No

Cavity development Yes No

Version 08_2010



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Data collection form for Legionella pneumonia

Patient ONKO-KISS ID: _____________________

At least one of the following signs confirmed by thoracic X-ray

New or progressive and persistent infiltrate Yes No

Consolidation Yes No

Cavity formation Yes No

Pneumatoceles, in infants <1 year old Yes No

At least one of the following:

Fever (38C) Yes No

Confusion without other cause in adults >70 years old Yes No

New purulent sputum Yes No

New cough or dyspnea or tachypnea

Yes No

Rales

or bronchial breath sounds Yes No

Worsening gas exchange Yes No

Hemoptysis Yes No

Pleural pain Yes No

And at least one of the following:

LEG Culture evidence or IF test Yes No

LEG_AG Evidence L.pneumophila AG in urine Yes No

LEG_AK Repeated quadrupling of antibody titer to > 1:128 Yes No

Version 08_2010



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10.4 Progress form for infection surveillance, Hematological /Oncological Units

(Example)

Patient:

Date Leukocytes Fever X-ray/ CT Pulmonary findings Microbio

Version 03_2011



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11 Legal Notice

National Reference Center (NRZ) for Surveillance of Nosocomial Infections (Director: Prof. Petra Gastmeier, MD) Charité-University Medicine Berlin A joint institution of Freie Universität Berlin und Humboldt Universität zu Berlin Hindenburgdamm 27 12203 Berlin Tel.: 030/8445 3680 Fax: 030/8445 3682 www.nrz-hygiene.de Technical Support, including webKess: Tel. 030/ 8445 3680 e-mail: [email protected] Partner Prof. Markus Dettenkofer, MD Institute for Environmental Medicine and Hospital Hygiene University Clinic Freiburg Breisacher Str. 115 B 79106 Freiburg Tel.: 0761/270 82750 Fax: 0761/270 82030 Robert Koch-Institut (RKI) Abteilung für Infektionskrankheiten, FG 14: Angewandte Infektions- und Krankenhaushygiene (Prof. Martin Mielke, MD) Nordufer 20 13353 Berlin Tel.: 030/4547 2233 Fax: 030/4547 2612

ONKO-KISS Contact

Institut für Umweltmedizin und Krankenhaushygiene

Albert Ludwigs-Universität Freiburg

Breisacherstraße 115 b – 79106 Freiburg

Prof. Markus Dettenkofer, MD (Project leader)

Tel.: 049 761/270 827/50 · Fax: 049 761/270 82530

E-mail: [email protected]

Regina Babikir (administration, organization, surveillance questions)

Tel.: 049 761/270-82750 · Fax: 0761/270-82030 E-mail: [email protected]

Last update: October 2012

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