Catheter-related Infection (CRI) in Irish Intensive Care Units

Transcription

1 Catheter-related Infection (CRI) in Irish Intensive Care Units A pilot surveillance study in collaboration with the Irish Critical Care Trials Group (ICCTG), Intensive Care Society of Ireland (ICSI), Health Protection Surveillance Centre (HPSC) and Health Service Executive Critical Care Program (HSE CCP) National Report May 2011

2 Contents Page: Executive Summary Introduction Methods Results ICU Demographics Data Completion Overall Patient Characteristics CVC Utilisation CVC Insertion and Removal Data CRI Data Microbiological Data Characteristics of Patients who Developed CRI CVC Insertion Data for CRI Conclusions and Recommendations Acknowledgements Funding Support 17 Appendices..18 Appendix A: Data Collection Forms...18 Appendix B: HELICS CRI case definitions Appendix C: Caveats Appendix D: Preliminary ICU Survey Results Appendix E: National CRI Audit Committee References

3 Executive Summary The national catheter-related infection (CRI) pilot surveillance project took place between November 1 st 2010 and January 31 st Nine hospitals participated in the study. This incorporated eleven intensive care units (ICUs) with capacities ranging from five to twenty-six beds. Overall completion of surveillance forms was very high at 99.5%, with valid surveillance forms received for 614 patients incorporating 1209 temporary central venous catheters (CVCs). The percentage of patients who had a CVC inserted varied greatly between the units (49% - 96%) with a national CVC utilisation figure of 71%. The median age of patients was 66 years with a male predominance (60%). The majority of CVCs were inserted in the ICU (63%) followed by the operating theatre (22%). The remaining CVCs were inserted in other hospitals (6%), the emergency department (5%), other areas of the hospital (3%) and on a ward (0.4%). The most common anatomical site of CVC insertion was the internal jugular vein (72%), followed by the femoral (17%) and subclavian (11%) veins. 84% of CVCs were inserted electively compared with 13% of CVCs which were inserted under emergency circumstances. Nationally, there were seventeen CRIs identified in the 1209 CVCs denoting a rate of 1.4 CRIs per 100 CVCs and a national CRI rate of 2.2 infections per 1000 CVC days (95% CI: ). CRI rates for individual units ranged from 0.0 to 8.1 CRIs per 1000 CVC days. The most common causative pathogen was coagulase-negative staphylococci, which was associated with six CRIs (35%), followed by Candida albicans which was associated with four CRIs (24%). Development of a CRI was associated with a longer ICU stay and patients who developed a CRI had more CVCs inserted and more CVC days than the patients without a documented CRI. The CRI rate for CVCs which were inserted in the ICU was 1.4 per 1000 CVC days which compared favourably with the rates of 5.2 and 10.4 for CVCs inserted in the operating theatre and in other areas of the hospital, respectively. A CRI rate of 3.0 per 1000 CVC days was identified for CVCs inserted in the internal jugular vein compared to a rate of 0.8 for CVCs inserted in the femoral vein. The CRI rate for CVCs inserted in emergency circumstances was 3.9 per 1000 CVC days compared to a rate of 2.0 for CVCs that were inserted electively. 2

4 1.0 Introduction The reduction of healthcare associated infection (HCAI) is vital to facilitate improvements in patient care and safety. Catheter-related infections (CRI) are one of the most frequent HCAIs and their associated morbidity, mortality and expense are the most significant adverse effect of central venous catheters* (CVCs). 1, 2 As a result, the reduction of CRI has been advocated as a measure of healthcare quality. 3 Patients admitted to an intensive care unit (ICU) have a five to ten-fold increased risk of developing a HCAI. 4 While some Irish ICUs conduct local CRI surveillance, using a variety of internationally recognised definitions, there is currently no national CRI surveillance programme in ICUs throughout Ireland. The aim of this pilot project was to, for the first time, institute surveillance of CRI in ICUs throughout Ireland utilising standard, uniform Hospitals in Europe Link for Infection Control through Surveillance (HELICS) definitions of CRI. 5 As the collected data were not adjusted for severity of critical illness, the results should be assessed on an individual ICU basis only and are not suitable for inter-hospital comparison. Appendix C contains details of the caveats that should be taken into account when interpreting these data. *Where the term CVC is used in this report, it refers to all of the temporary CVCs captured in the study (including standard CVCs, Vascaths and pulmonary artery catheter introducers) 3

5 2.0 Methods Study Setting and Population The national CRI surveillance pilot project took place between November 1 st 2010 and January 31 st 2011 as a multicentre study with prospective collection of data in eleven ICUs from nine Irish hospitals. Participation of the ICUs in the project was on a voluntary basis. In accordance with the HELICS protocol, the study population comprised all patients 18 years of age, admitted to the ICU for more than 48 hours during the study period, who had a non-tunnelled CVC inserted; incorporating standard multi-lumen CVCs, Vascaths and pulmonary artery catheter (PAC) introducers. Patients with tunnelled catheters, peripherallyinserted central catheters (PICC) or peripheral intravenous cannulae were excluded. Patients were not followed beyond discharge from ICU, as is the recommendation of the HELICS protocol. National CRI Audit Committee The national CRI audit committee comprised three Consultants in Intensive Care Medicine, a Consultant Microbiologist, a Specialist Registrar in Microbiology, two surveillance scientists (one acting as dedicated CRI project data manager), and two CRI audit nurses. Prior to commencement of the study, the national CRI audit committee met weekly and decided upon: (i) The use of HELICS definitions of CRI (ii) The use of level 2 (or patient-based) data collection (iii) The content and design of the study protocol, CRI patient surveillance form, denominator form, and positive microbiology form (See Appendix A) All information (protocol, forms, etc.) relevant to the study, including a section on frequently asked questions (FAQ) were posted on the website of the Health Protection Surveillance Centre (HPSC) and maintained throughout the study period. Throughout the data collection period, the national CRI audit committee met via weekly teleconference to discuss ongoing data collection, returned forms, and any issues raised by local audit nurses in the course of the local data collection and local multidisciplinary team (MDT) discussions. 4

6 Local CRI Audit Nurse Each participating ICU nominated a senior nurse to act as local CRI audit nurse responsible for local data collection. Completed, anonymised data from each participating ICU were returned centrally to the data manager who was based in the HPSC. Two of the local CRI audit nurses also undertook the roles of national CRI audit nurse coordinators, acting as nominated contact points for other local CRI audit nurses, providing support, feedback and information and highlighting any issues that arose during the study period to the national CRI audit committee. Prior to study commencement, two training days were held in Dublin and all CRI audit nurses attended to receive training on the study protocol, which incorporated detailed information regarding CRI diagnosis, CRI surveillance form completion and the data return processes. In addition, sample patient case studies were presented as part of the training process, incorporating completion of patient surveillance forms for further demonstration of the study protocol with provision of immediate feedback to participants. CRI Multidisciplinary Team In order to facilitate consistent diagnosis of CRI, each participating ICU convened a multidisciplinary team (MDT) comprising a Consultant in Intensive Care Medicine, Consultant Microbiologist, senior ICU nursing staff, in addition to the local CRI audit nurse. All patients with suspected CRI were presented by the local CRI Audit Nurse to the MDT at weekly meetings and discussed on a case-by-case basis. CRI Diagnosis CRI diagnosis was made according to the HELICS case definitions for CRI 4 (Appendix B). The CRI4 (bloodstream infection) category is not an official HELICS definition as it was developed specifically for this pilot study. This category was proposed in the initial stages of consultation by the national CRI audit committee to allow for inclusion of those cases of CRI where sufficient clinical evidence exists to diagnose CRI in the setting of bacteraemia due to pathogens usually considered non-significant (such as coagulase-negative staphylococci), but where only one set of blood cultures had been taken from the patient. The HELICS CRI3 definition requires at least two sets of blood cultures to yield positive growth for a nonsignificant pathogen in order to meet the case definition. 5

7 Microbiological Diagnosis of CRI All nine microbiology laboratories completed a short survey regarding current diagnostic practices for CRI. Eight of the nine participating microbiology laboratories processed CVC tips for culture and further identification and susceptibility testing in the event of significant growth being detected or if specifically requested. One laboratory did not process CVC tips and as a result it was not possible for the participating ICUs from that hospital to meet the case definition for CRI1, CRI2, or part of CRI3 and of CRI4 (where positive blood cultures and tip were required). Due to this inability to comply fully with the HELICS protocol, the data collected from the two ICUs served by this microbiology laboratory were not included in the national analysis, other than for the calculation of the national CRI3 rate. Of the eight laboratories that processed CVC tips, seven used the Maki roll plate (semiquantitative) method with greater than 15 colony forming units (CFUs) being the cut-off for significant growth. One laboratory used sonication broth (quantitative) method with 100 CFUs being the cut-off for significant growth. Five of nine participating laboratories reported exact time to positivity when reporting blood culture results, thus facilitating calculation of differential time to positivity (DTP) when comparing simultaneously-taken blood cultures from a CVC and a peripheral percutaneous (clean-stick) site. The definition of DTP provided in the 2004 HELICS guidelines contained a typographical error as it stated that the CVC culture flags positive two hours or less before the peripheral culture. The correct definition is that the CVC culture flags positive two hours or more before the peripheral culture. 5 This error has been corrected in the updated HELICS ICU protocol published in December Although the CRI study protocol and patient surveillance form quoted the 2004 definition, once the typographical error was noted all units using this method were contacted to ensure the correct definition was being used. Also the correct DTP definition was taught during the audit nurse training days and was also conveyed in writing during the survey of laboratory diagnostic practices. Data Collection The CRI patient surveillance form (Appendix A) was structured to facilitate recording of data on up to four CVCs during a patient s admission to ICU. In addition, the denominator form and positive microbiology forms (Appendix A) assisted data collection. All data were collected in paper format at local ICU level by the ICU audit nurse. 6

8 Once completed locally and signed off by the local MDT, the CRI patient surveillance forms and denominator forms were returned centrally to the data manager. A Microsoft Access database was designed by the data manager and upon receipt of CRI forms, data were crosschecked and manually entered into the database and used for subsequent data analysis. Additionally, questionnaires were distributed to all participating ICUs during the study to ascertain current CVC insertion and maintenance practices. Data Analysis CVC tip culture was not available in the microbiology laboratory of one hospital. Therefore this hospital could only diagnose one category of CRI, namely CRI3, using the DTP method (CRI diagnosis by DTP is included in the HELICS definitions in Appendix B). In view of this, the results of two participating ICUs in that hospital were excluded from the overall analysis and therefore, this report incorporates the results obtained from nine participating ICUs in eight hospitals. However, in order to facilitate the inclusion of any CRI3 diagnosis reached in the ninth hospital, the data collected in this hospital was included in the analysis and calculation of the national CRI3 rate. The data from this ninth hospital was not included in any other analysis or results, including the overall CVC demographic data, the national CRI rate or the national CRI1 and CRI2 rates. Validation Processes Each suspected case of CRI was discussed at a local MDT meeting. In the event that the HELICS definitions were achieved, the corresponding CRI type (CRI1, CRI2, CRI3 or CRI4) was assigned and signed off by both the Intensive Care Consultant and the local CRI audit nurse, prior to the return of the completed form to the data manager at the HPSC. Throughout the three-month period of data collection, the national CRI audit nurses made contact with each individual CRI audit nurse on a weekly basis to provide external support and answer any queries as they arose. As an external validation exercise, members of the national CRI audit committee met at the end of the study period to review all of the patient surveillance forms where CRI episodes had been assigned locally, as well as a random selection of an equal number of patient surveillance forms where no CRI episodes had been assigned locally. 7

9 3.0 Results 3.1 ICU Demographics Nine hospitals participated in the pilot project (See Table 1). For reasons outlined above, the results of only eight hospitals, incorporating nine ICUs, are included in the overall national dataset. The results of the ICU survey on CRI prevention and control practices are contained in Appendix D. Table 1: Demographic data of participating hospitals Hospital Name Hospital Region Hospital Type ICU Bed Capacity* Adelaide & Meath & National Children s Hospital, Tallaght Dublin Midlands Tertiary 9 Beaumont Hospital (two participating ICUs) Dublin North East Tertiary 20 Cork University Hospital (two participating ICUs) Southern Tertiary 14 Mater Misericordiae University Hospital Dublin North East Tertiary 26 (ICU and HDU included as one critical care unit) Sligo General Hospital West/North Western General 5 St Vincent's University Hospital Dublin South Tertiary 11 University College Hospital Galway West/North Western Tertiary 9 Waterford Regional Hospital South Eastern Tertiary 6 Wexford General Hospital South Eastern General 5 *Source: Critical Care Capacity Census 2010, HSE Critical Care Programme 3.2 Data Completion CRI patient surveillance forms were received for 1,212 CVCs inserted in 617 patients. Tables 2 and 3 summarise the percentage completion of CRI patient surveillance forms. Overall, completion of surveillance forms was extremely high (99.5%) resulting in valid CRI patient surveillance forms for 1209 CVCs inserted in 614 patients (Table 3). Table 2: Completion rates for all surveillance forms received Number of patients* Number of CVCs Percentage of valid forms % Abbreviations: CVC central venous catheter * Number of patients aged 18 years who had a temporary CVC inserted and who remained in ICU >2 days during the study period. Valid forms are those where ICU admission date, CVC insertion date and either CVC removal date or ICU discharge date are completed (Note: exceptions were made for patients who remained in the ICU at the end of the study period with a CVC in situ. These forms were considered valid and the study end date (31/01/2011) was substituted for removal date. 8

10 While the completion rates of individual data items were high (Table 3), the rate for CVC removal was lower. The removal date was left blank, as per study protocol, for 235 (19%) CVCs which remained in situ at patient discharge from ICU. CVC removal date was not completed for a further 59 (5%) CVCs due to patient death with the CVC in situ. Table 3: Completion rates for valid surveillance forms Question Number Completed Completion rate Age % Gender % Date of admission to hospital % Site of CVC insertion % Hospital location of CVC insertion % CVC removal date* % Date of discharge from ICU % Abbreviations: CVC central venous catheter, ICU intensive care unit * When a patient left the ICU with a CVC in situ, the protocol was to CVC removal date blank Date of discharge from ICU was left blank (by protocol) for patients who remained in the ICU at the end the study period (31 st January 2011) 3.3 Overall Patient Characteristics The median age of the 614 patients included in the analysis was 66 years [interquartile range (IQR): 52 75] (Table 4). There was a male predominance (60%) with females accounting for 39% of patients. During the three-month study period, 120 patients died giving an ICU mortality rate of 20%. The median length of stay (LOS) in the ICU was seven days [IQR: 4 14]. Each patient had a median of one CVC inserted [IQR: 1 2] and each CVC was in situ for a median of six days [IQR: 4 8]. The median total number of CVC days per patient was eight days [IQR: 5 14]. However, these CVC days could run concurrently if the patient had more than one CVC in situ at once. 9

11 Table 4: Patient Characteristics Number of patients included in final analysis 614 Number of CVCs included in final analysis 1209 Sex, number (%) Male Female 369 (60%) 241 (39%) Age, median (IQR), days 66 (52 75) ICU mortality, number (%) 120 (20) Length of stay in ICU, median (IQR), days 7 (4 14) Number of CVCs inserted in each patient, median (IQR) 1 (1 2) CVC dwell time per CVC, median (IQR), days 6 (4 8) Total CVC days per patient, median (IQR) 8 (5 14) Abbreviations: CVC central venous catheter, IQR interquartile range, ICU intensive care unit 3.4 CVC Utilisation CVC utilisation represents the percentage of patients in the ICU, over the three month study period, who had one or more CVCs inserted. Nationally, CVC utilisation was 71% however utilisation in the individual units ranged from 49% to 96% with median of 65% (Figure 1). These data are not adjusted for differences in patient case-mix. Figure 1: National and individual ICU CVC utilisation 10

12 3.5 CVC Insertion and Removal Data CVC insertion details are presented in Table 5. The majority of CVCs were inserted in the ICU (63%), followed by the operating theatre (22%). The most common site of CVC insertion was the jugular vein (72%) followed by the femoral (17%) and subclavian (11%) veins. 84% of CVCs were inserted electively and 13% were inserted under emergency circumstances. The most common type of CVC was the standard CVC (68%), followed by the Vascath (29%). Only four ICUs reported use of PAC introducers with a single unit accounting for 91% of the 43 used during the three month study period. Of the CVCs that were removed during the study period, 41% were removed because they were no longer needed and 32% were removed due to suspected CRI. Of the 168 (19%) CVCs removed for other reasons, 96 were removed because the patient had died. Table 5: CVC insertion and removal data Number % Location of CVC insertion Intensive Care Unit Operating Theatre Other hospital 71 6 Emergency Department 61 5 Other area of hospital 33 3 Ward Missing 15 1 Site of CVC insertion Jugular vein Femoral vein Subclavian vein Missing Circumstances of CVC insertion Elective Emergency Unknown 14 1 Missing 19 2 Type of temporary CVC Standard CVC Vascath PAC introducer 43 4 Missing CVC removal reason CVC no longer needed CRI suspected Other reason for CVC removal CVC malfunction 50 6 Missing 11 1 Abbreviations: CVC central venous catheter, PAC pulmonary artery catheter, CRI catheter related infection 11

13 3.6 CRI Data Nationally, there were seventeen CRIs identified in 1209 CVCs denoting a rate of 1.4 CRIs per 100 CVCs and resulting in a national CRI rate of 2.2 infections per 1000 CVC days (95% Confidence Interval (CI): ). Table 6: National CRI rate CRI rate Number of CRIs Number of ICU CVC days* (95% Confidence Interval) ( ) Abbreviations: ICU intensive care unit, CVC central venous catheter * Number of ICU CVC days = (removal date insertion date + 1). Only CVC days where the patient is present in the ICU are included. If the CVC was inserted before ICU admission then admission date replaces insertion date in the above formula. Similarly if the patient leaves the ICU with the CVC in situ then ICU discharge date is used instead of removal date. For CVCs which remained in situ at the end of the study period the 31/01/2011 was substituted for removal date. HELICS CVC infection rate is the number of infections per 1000 CVC days The CVC infection rate by CRI type is provided in Table 7. The majority of infections identified were categorised as CRI3 (the most significant of the HELICS CRI definitions, indicating that the patient had documented bacteraemia) giving a rate of 1.39 per 1000 CVC days (95% CI: ). Six CRI2 (signs of systemic sepsis without bacteraemia) and one CRI1 (superficial exit site infection in the absence of signs of systemic sepsis) were identified giving rates of 0.79 (95% CI: ) and 0.13 (95% CI: ) per 1000 CVC days, respectively. The CRI4 (bloodstream infection) category was developed for this pilot study and is not an official HELICS definition. However, no CRI4 was identified in the study and it is therefore not included in Table 7. Table 7: CRI rate by infection type Infection type Number of CRIs Number of CVC days CRI rate* 95% CI CRI CRI CRI Abbreviations: CRI catheter related infection; CVC central venous catheter * Per 1000 CVC days See Appendix B for CRI definitions The calculation for CRI3 includes infection and denominator data from two ICUs which only diagnosed CRI by DTP and were therefore unable to identify CRI1, CRI2 or CRI4 12

14 Figure 2 presents the overall CRI rates (incorporating CRI1, CRI2 and CRI3) of the participating ICUs along with the national overall CRI rate of 2.2 CRIs per 1000 CVC days and the CVC utilisation for the individual units. Overall CRI rates for individual ICUs ranged from 0.0 to 8.1 per 1000 CVC days with a median rate of 1.3 CRIs per 1000 CVC days. Three of the ICUs reported that no CRIs were detected during the three-month study period. Figure 2: CRI rates of individual ICUs compared with national CRI rate 3.7 Microbiological Data Figure 3 presents the organisms associated with the seventeen CRIs. The most common causative pathogen was coagulase-negative staphylococci, which was associated with six CRIs (35%) [four CRI2 and two CRI3]. Candida albicans was the causative pathogen for four CRIs (24%) [two CRI2 and two CRI3]. Figure 3: Number of CVC infections by organism type 13

15 3.8 Characteristics of Patients who Developed CRI Table 8 presents the characteristics of the patients who developed a CRI compared to the overall study population and to the patients without a documented CRI. Development of a CRI was associated with a longer LOS in the ICU. Patients who developed a CRI had more CVCs inserted [median: 3; IQR: 2 5] compared to those without a CRI [1; IQR: 1 2], with each infected CVC being in situ for a median of seven days [IQR: 2 5] prior to a CRI developing. The total number of CVC days for patients with a CRI [16; IQR: 10 46] was double that of patients without a CRI [8; IQR 4 14]. However, these CVC days could run concurrently if the patient had more than one CVC in situ at any one time. Table 8: Patient characteristics by CRI status Overall Patients without Patients with CRI CRI Number of patients Sex, number (%) Male Female 369 (60) 241 (39) 361 (60) 235 (39) 8 (53) 6 (40) Age, median (IQR), years 66 (52 75) 66 (53 76) 54 (35-70) Length of stay in ICU, median (IQR), days 7 (4 14) 7 (4 14) 17 (12 34) Number of CVCs inserted in each patient, median (IQR) 1 (1 2) 1 (1 2) 3 (2 5) CVC dwell time, median (IQR), days 6 (4 8) 6 (4 8) 7 (5 8) Total CVC days per patient, median (IQR) 8 (5 14) 8 (4 14) 16 (10 46) ICU mortality, number (%) 120 (20) 118 (20) 2 (13) Abbreviations: CRI catheter related infection; IQR interquartile range; ICU intensive care unit 14

16 3.9 CVC Insertion Data for CRI The CVC insertion information for the seventeen CRIs is presented in Table 9. Seven CRIs developed in CVCs inserted in the ICU, resulting in a CRI rate of 1.4 per 1000 CVC days. This compares favourably with CRI rates of 5.2 and 10.4 for CVCs inserted in operating theatres and other areas of the hospital, respectively. All but one of the CRIs identified during the study developed in CVCs inserted in the internal jugular vein resulting in a CRI rate of 3.0 per 1000 CVC days. The one remaining CRI developed in a CVC inserted in the femoral vein giving a CRI rate of 0.8 per 1000 CVC days. No CRI was indentified in CVCs inserted in the subclavian vein. This follows the trend of overall CVC insertions as the majority were inserted in the internal jugular vein. The CRI rate for CVCs inserted in emergency circumstances was 3.9 per 1000 CVC days compared to a rate of 2.0 for CVCs that were inserted electively. The CRI rates were similar for standard CVCs and Vascaths (2.1 and 2.8 per 1000 CVC days, respectively). No CRIs developed in PAC introducers. Table 9: Insertion data for CVCs and CRIs Number of CVC insertions Number of CVC days % of CVC days Number of CRIs CRIs per 100 CVCs CRIs per 1000 CVC days Location of CVC insertion Intensive Care Unit Operating Theatre Other hospital Emergency Department Other area of hospital Ward Site of CVC insertion Jugular vein Femoral vein Subclavian vein Circumstances of CVC insertion Elective Emergency Type of temporary CVC Standard CVC Vascath PAC introducer Abbreviations: CVC catheter related infection; CRI catheter related infection: PAC pulmonary artery catheter 15

17 4.0 Conclusions and Recommendations Key to the success of this study was the buy-in of the critical care and microbiology community together with the support of the HSE. The study was further strengthened by the utilisation of uniform diagnostic criteria (HELICS) for CRI and that all CRI were assigned by a MDT comprised of a lead critical care clinician, CRI surveillance nurse and microbiologist. While the findings of this short pilot study are not appropriate for inter-hospital comparisons, the results, incorporating information on an individual ICU s patient demographics and infection prevention practices, can be utilised to review, apply and maintain appropriate infection control measures and should a unit decide to conduct further CRI surveillance, rates can be monitored over time from this baseline CRI rate. The processes developed in this pilot study, along with the results of feedback forms which will be sent to all ICU audit nurses and ICU lead clinicians, can be used to develop and refine any future CRI surveillance in ICUs. Based on the results of this study, the national CRI audit group have made the following conclusions and recommendations: 1. This pilot study showed that the use of HELICS diagnostic criteria for the diagnosis of CRI functioned well for national surveillance. Using these diagnostic criteria, this pilot study provided a baseline CRI rate for each ICU and facilitates further CRI audit within each institution. 2. Ongoing surveillance of CRI in ICUs, although labour intensive, is recommended to promote the minimisation of CRI episodes and to allow ongoing evaluation of processes, aimed at the reduction of CRI incidence. 3. We recommend that future projects strive to ensure equal compliance of the units to the surveillance protocol. 4. We believe that all critical care units should prioritise implementation of the recommendations of the Strategy for Control of Antimicrobial Resistance in Ireland (SARI) national guideline for prevention of intravascular catheter-related infection,

18 5. The capacity to perform more detailed patient risk factor analysis and risk stratification should be a future goal for an adequately resourced national surveillance programme of CRI in critical care. The data included in this report will be submitted for publication in a peer-reviewed journal in due course. This publication will incorporate statistical analysis in addition to more detailed analysis and discussion of the results. 5.0 Acknowledgements We are grateful to the following for invaluable advice and assistance: Dr. Fidelma Fitzpatrick, HSE/Royal College of Physicians of Ireland Clinical Lead Prevention of HCAI and Consultant Microbiologist, Health Protection Surveillance Centre & Beaumont Hospital, Dublin. Professor John Laffey, Professor of Anaesthesia, University College Hospital Galway. The collaborative study steering group bodies The Irish Critical Care Trials Group, the Intensive Care Society of Ireland, the Health Protection Surveillance Centre and the HSE Critical Care Programme The members of the local MDTs for their invaluable contribution to the collection of the study data. 6.0 Funding Support Funding was acquired from the HSE Critical Care Programme to secund the equivalent of eight 0.5 whole-time equivalent local ICU nurses to act as dedicated CRI audit nurses and carry out data collection. Funding was received from the Intensive Care Society of Ireland and, in the form of an unrestricted grant, from Merck Sharpe & Dohme (MSD) to assist in the funding of a dedicated Data Manager for the study. 17

19 Appendix A: Data Collection Forms CRI Surveillance Form: 18

20 19

21 ICU Denominator Form: 20

22 Positive Microbiology Form: 21

23 Appendix B: HELICS Catheter-related Infection Case definitions 4 CRI 1, CRI 2, CRI 3 are strict HELICS definitions. CRI 4 has been added for the purposes of this study. CRI 1 = SUPERFICIAL EXIT SITE INFECTION [HELICS Definition] (NO POSITIVE BLOOD CULTURE(S) RECORDED) Growth of a significant organism* in significant quantities on the CVC tip (significant quantity as defined by local microbiology lab methods) AND Red or inflamed CVC exit site CRI 2 = SYSTEMIC SEPSIS WITHOUT BACTERAEMIA [HELICS Definition] (NO POSITIVE BLOOD CULTURE(S) RECORDED) Growth of any organism in significant quantities on the CVC tip (significant quantities as defined by local microbiology lab methods) and the CVC was removed from a patient with clinical evidence for infection AND Clinical signs of infection improve within 48 hours after removal of temporary CVC CRI 3 = CVC RELATED BLOODSTREAM INFECTION (BSI) [HELICS Definition] (POSITIVE BLOOD CULTURE(S) RECORDED) One or more positive blood culture(s) with growth of a significant organism* (occurring 48 hours before or after removal of CVC) OR Two or more positive blood cultures taken within 48 hours of each other with growth of an organism usually considered as non significant* AND EITHER Growth in significant quantity from the CVC tip of the same organism as isolated from the blood culture (significant quantity as defined by local laboratory method) OR Growth of the same organism from the swab of the CVC exit site pus/erythema as isolated from the blood culture OR In event that simultaneous blood cultures have been taken from the CVC, which is suspected to be infected and from peripheral vein, where the CVC blood culture flags positive two hours or more before the peripheral blood culture, with isolation of the same organism from both CVC blood culture and the peripheral blood culture 22

24 CRI 4 = CVCRELATED BLOODSTREAM INFECTION (BSI) (POSITIVE BLOOD CULTURE MUST BE RECORDED) In the event that only ONE blood culture set is taken from the CVC with positive growth for a pathogen which is usually considered to be nonsignificant* AND EITHER AND Growth in significant quantity of the same organism as isolated from the blood culture from the CVC tip (significant quantity as defined by local lab method) OR Growth of the same organism as isolated from the blood culture from a swab of pus/erythema taken from the CVC exit site THE LOCAL MDT/COMMITTEE MEETING DECIDES THAT THE PATIENT HAD EVIDENCE FOR CRI AND NO ALTERNATIVE SOURCE FOR INFECTION COULD BE IDENTIFIED * Organisms that are considered significant include; Staphylococcus aureus, Enterococcus sp, Beta Haemolytic streptococci (Group A, B, C, G, F), any of the Gram-negative organisms and any Candida albicans or other Candida sp, yeast or fungal growth. Organisms that are considered nonsignificant include; skin flora; (coagulase-negative staphylococci/s. epidermidis, Propionibacterium sp, Corynebacterium sp, Micrococcus sp, Bacillus sp etc.) 23

25 Appendix C: Caveats There are limitations with this pilot study which need to be considered when drawing any conclusions from the data: The resources and timeframe of this pilot project did not allow for external data validation to be carried out within the participating units to determine the sensitivity and specificity of the surveillance. Consequently there are no data on the compliance of ICUs with the surveillance protocol (e.g. the taking of blood cultures at the time of every episode of a suspected CRI) and the results should be interpreted in this light. However there were MDT reviews of all suspected episodes of CRI, uniform CRI recording and sign-off processes and a very high level of surveillance data completion. Nevertheless, this possibility of varying local protocol compliance means that inter-hospital comparisons are not possible. Due to the large variability in the acuity, size and case-mix of the ICUs involved, it is inappropriate to make direct comparisons between ICUs. Hospitals with more atrisk practices and specialities are likely to experience more complex acute cases, higher CVC utilisation and higher CRI rates than hospitals with more low-risk practices and specialties. In the absence of a robust measure of patient acuity (e.g., APACHE score) it is not possible to stratify ICUs according to case-mix. There are many factors which may have relevance to the occurrence of CRIs in CVCs which this study did not measure or analyse. These include hospital/icu practices and policies relevant to CVC insertion and removal, the use of CVC care bundles, the reason for CVC insertion, the use of antimicrobial therapy and the level of provision of infection control resources. For example of the nine ICUs, two units use CVC insertion bundles or checklists. The data presented in this report are based on results collected over a three-month period. The number of CRIs reported may therefore be deceptive, particularly for smaller hospitals, as small differences in the numerator or denominator may dramatically affect the rates calculated. It is therefore not recommended to make comparisons between hospitals. 24

26 Differences between hospital microbiology diagnostic methods are another reason to invalidate inter-hospital comparisons. All ICUs included in the national rate had laboratories that provided blood culture, CVC tip culture and exit site swab culture results to identify CRIs. However, some of the laboratories also had the capacity to use the criterion of differential time to positivity (DTP) for simultaneously collected CVC and peripheral percutaneous blood cultures. Therefore, depending on the sensitivity of the DTP method, these units may have higher CRI rates as they could identify additional CRIs that might not have met the HELICS CRI definitions in units where DTP was not used. Appendix D: Preliminary ICU Survey Results The ICU survey results demonstrated that prior to this pilot study, eight (89%) ICUs were already conducting some form of local CRI surveillance. Of these, five ICUs were using the United States Centers for Disease Control and Prevention (CDC) protocol for catheter related bloodstream infections (CRBSI). A further three units were conducting bacteraemia surveillance and one of these units was using the HELICS protocol for bacteraemia surveillance. The results of the ICU survey showed that two (22%) ICUs used CVC insertion bundles and both included an insertion checklist as part of the CVC insertion bundle. Three (33%) ICUs employed a CVC maintenance care bundle and four (44%) used either antimicrobial or antiseptic-impregnated CVCs. CVC infection prevention and control practices in participating ICUs Number of ICUs Percentage of ICUs CRI surveillance 8 89% CVC insertion bundle 2 22% CVC insertion checklist 2 22% CVC care bundle 3 33% Use of impregnated or coated CVCs 4 44% Abbreviations: CRI catheter related infection, CVC central venous catheter, ICU intensive care unit 25

27 Appendix E: National CRI Audit Committee Dr Criona Walshe, Consultant in Anaesthesia and Intensive Care Medicine, Beaumont Hospital, Dublin. Principle Investigator. Dr Dermot Phelan, Consultant in Intensive Care Medicine, Mater Misericordiae University Hospital, Dublin. Dr Karen Burns, Consultant Microbiologist, Health Protection Surveillance Centre, Beaumont Hospital & HSE-CCP. Ms Margaret Foley, Surveillance Scientist, Health Protection Surveillance Centre, Dublin. Data Manager for study. Ms Fiona Roche (PhD), Surveillance Scientist, Health Protection Surveillance Centre, Dublin. Dr Marianne Fraher, SpR Microbiology, St. James Hospital, Dublin. Dr Ian Conrick-Martin, Critical Care Fellow, Mater Misericordiae University Hospital, Dublin. Dr Michael Power, Critical Care Programme Lead, Clinical Strategy and Care Programmes Directorate, HSE. Ms Margaret Healy, CNM Sligo General Hospital. National Audit Nurse Coordinator. Ms Patricia Morrison, CNM Adelaide & Meath, incorporating the National Children s Hospital, Dublin. National Audit Nurse Coordinator. 26

28 References: 1. Sax H, Pittet D. Inerhopital differences in nosocomial infection rates: importance of case-mix addjustment. Arch Intern Med 2002; 162(21): Blot SI, Depuydt P, Annemans L, Benoit D, Hoste E, De Waele JJ, Decruyenaere J, Vogelaers D, Colardyn F, Vandewoude KH. Clinical and economic outcomes in critically ill patients with nosocomial catheter-related bloodstream infection. Clin Infect Dis 2005; 41(11): Berenholtz SM, Dorman T, Ngo K, Pronovost PJ. Qualitative review of intensive care unit quality indicators. J Crit Care 2002; 17(1): European surveillance of healthcare-associated infections in intensive care units (HAIICU): Protocol Version 1.01, Standard and Light. European Centre for Disease Prevention and Control, Surveillance of nosocomial infections in intensive care units, Protocol Version 6.1. Hospital in Europe Link for Infection Control through Surveillance, Prevention of intravascular catheter-related infection in Ireland. SARI Prevention of Intravascular Catheter-related Infection Sub-Committee, Health Protection Surveillance Centre,