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					 Central Venous Catheter - Associated Blood Stream Infections In Intensive Care Units
             and in Recipients of Haematopoeietic Stem Cell Transplants.

                                  CNISP December 22, 2005

INTRODUCTION

BACKGROUND

OBJECTIVE

PROPOSAL
     METHODS
          Eligibility to participate
          Patient population
          Surveillance period
          Denominators
          Case definitions
          Case-finding
          Case descriptive data
          Rate calculations
          ICU and hospital descriptive data
          Ethics
          Public access to individual CNISP site data

WORKLOAD

REFERENCES

ANNEX A:     Replaced by Appendix I
ANNEX B:     Denominator data collection forms – Intensive Care Units (examples)
ANNEX C:     CVC-associated BSI Surveillance In Haematopoeietic Stem Cell Transplant
             (HSCT) Recipients
ANNEX D:     HSCT Denominator Data Collection Form
ANNEX E:     NNIS and CHEC 1997 CVC-associated BSI definitions (for information only)

             __________________________________________________


WORKING GROUP

Dorothy Moore, Lynn Johnston (Co-Chairs), Elizabeth Henderson, Michael John, Joanne
Langley, Kathy Suh, Geoff Taylor, Zahir Hirji, Alice Newman, Karen Olekson, Denise Gravel




                                                    1 of 21 CNISP CVC-BSI protocol Dec 22-05
INTRODUCTION

Nosocomial bloodstream infections (BSI) are an important cause of morbidity and mortality in severely
ill patients, and a significant proportion of these infections are associated with the presence of central
venous catheters (CVC). As several potentially modifiable factors influence the risk of development of
a catheter-associated BSI, appropriate infection control and prevention activities have an important
impact on infection rates. (1,2,3).

Surveillance is an essential component of infection control. If carried out in a uniform manner,
surveillance provides a measure of the burden of illness, establishes benchmark rates for internal and
external comparison, identifies potential risk factors, and allows assessment of specific interventions.
Surveillance for CVC-associated BSI (CVC-BSI) is considered as a measure of quality of care.

BACKGROUND

Although the majority of nosocomial BSIs are associated with the use of a CVC, these devices have
become essential to the care of patients with complex severe illnesses, especially those in intensive
care units (ICU). Highest rates are reported in neonatal, pediatric, trauma and burn ICUs (4). Infection
rates vary by type of catheter. Combined data from several studies indicate pooled mean rates per
1000 CVC-days of 2.3 for regular short term CVC, 0.4 for peripherally inserted central catheters, 1.2 for
long term tunnelled cuffed catheters, and 0.2 for totally implanted devices (5). Other risk factors include
catheter insertion and care practices, products administered through the line, frequency of
manipulation, age group, underlying disease, and severity of illness of the patient (1). Infection risk
also increases with understaffing in ICU (6).

The skin is the main source of organisms causing CVC-BSI. Infection may occur as a result of
migration of microorganisms from the insertion site along the percutaneous tract. This may occur
during insertion or later, especially if the catheter is manipulated, if it is not securely anchored and
therefore mobile at the entry site or if the entry site becomes infected. Organisms may also be
introduced into the catheter lumen from the external surface of the catheter or administration tubing at
junction sites, especially when these are disconnected, or through cracks in the external portion of the
catheter or some component of the administration set. The catheter hub is an important source of
infection of tunnelled catheters in place for more than 30 days. Infection risk can be lowered by
maintaining appropriate aseptic technique during catheter insertion, care of the entry site, and catheter
manipulation (1,7). Intrinsic contamination of parenteral nutrition (PN) or other infusion fluid may also
occur. Use of commercially prepared sterile infusion fluids and preparation of PN in the central
pharmacy under aseptic conditions has essentially eliminated this source of infection. Occasionally
hematogenous contamination of the catheter from another septic focus may occur, especially in
immunocompromised patients.

The types of organisms most frequently involved in CVC-BSI are coagulase negative staphylococci,
Staphylococcus aureus, enterococci, Candida spp and gram negative bacilli. Antibiotic-resistant strains
are frequently encountered. Administration of intravenous lipid is an independent risk factor for BSI
with coagulase negative staphylococci and with Candida in patients in neonatal intensive care units (1).

An estimated 80,000 CVC-associated BSIs occur each year in the United States. The National
Nosocomial Infections Surveillance System (NNIS) has monitored hospital-acquired infections since
1970 in approximately 300 US hospitals. NNIS reports rates of CVC-BSI per 1000 CVC days by ICU
type. For 2002-2004, pooled mean rates ranged from 2.7 for cardiothoracic ICU to 7.4 for trauma ICU.
Rates in pediatric ICU were 6.6 and in neonatal ICU 3.5 to 9.1 for different birth weight groups (4). The

                                                            2 of 21 CNISP CVC-BSI protocol Dec 22-05
attributable mortality for these infections remains unclear. The attributable cost is substantial at an
estimated $34,000-56,000 per infection (1). Several strategies have been shown to be effective in
reducing rates of CVC-BSI (1). In the NNIS hospitals, rates of CVC-BSI decreased between 1990 and
1999 by 44% in medical ICU, 43% in coronary ICU, 32% in pediatric ICU and 31% in surgical ICU (8).

Ongoing surveillance for CVC-BSI is also carried out in England. From 1997-2001, 73 hospitals
reported a total of 1888 CVC-BSIs. In teaching hospitals, the largest numbers of infections and highest
rates per 1000 patients at risk were noted in ICU, oncology, hematology, nephrology and special care
baby units while in non-teaching hospitals, general medicine, general surgery and geriatric wards
accounted for a large percentage of infections (9)

Data from 1997-2001 from 212 ICU participating in the German nosocomial infection surveillance
program showed lower rates of infection than reported by NNIS. Pooled mean rates per 1000 CVC-
days ranged from 1.1 in neurosurgical ICU to 4.7 in pediatric ICU. During this surveillance period an
overall decrease in rate from 2.1 to 1.6 was observed (7).

An international study in 1998-2000 using NNIS methods reported rates of 3.82 ± 0.38 per 1000 CVC-
days for ICU in 41US hospitals and 5.02 ± 0.75 for ICU in 15 hospitals in Europe, Asia, Middle East
and South America (10).

A six month study carried out by the Canadian Nosocomial Infection Surveillance Program in 1997 in
41 ICUs in 19 hospitals across Canada reported a total of 182 CVC-BSIs. Mean rates per 1000 CVC-
days for adult, pediatric and neonatal ICU were 6.2, 5.6 and 7.5 respectively (11).

A 6 month study in 43 ICUs in 21 hospitals in Quebec in 2001 reported 92 infections. Pooled mean
rates were 2.5, 2.1 and 8.6 per 1000 CVC-days for adult, pediatric and neonatal ICU respectively
(12,13). Ongoing surveillance for CVC-BSIs is now being carried out in 38 ICUs in 28 hospitals in the
province. Median rates per 1000 CVC-days for the first 18 months of surveillance were 1.73, 2.16, 2.32
and 4.23 for adult university, adult non-university, pediatric and neonatal ICUs (14).

Surveillance for CVC-BSIs is considered an important measure of quality of care. A recent CDC
statement regarding public disclosure of hospital-associated adverse events suggests that the rate of
CVC-associated BSIs in ICU be considered as one outcome measure to be monitored and CVC
insertion practices as a process measure (15,16).

OBJECTIVE:

The objective of this program is to establish ongoing surveillance for CVC-BSI in ICUs in a network of
Canadian hospitals and to determine mean and percentile infection rates which hospitals may use as
benchmarks for external comparison.

A secondary objective is to reduce the rates of CVC-BSI in ICU. The literature suggests that the
performance of surveillance for BSI and feedback of data to caregivers results in reduction in infection
rates (7,8). Routine standardized collection of data on infection rates also permits individual centers to
evaluate specific infection control and prevention interventions.

PROPOSAL:

The first step proposed is to set up a system of ongoing surveillance within the CNISP hospital
network, based on the NNIS model and the system being used in the province of Quebec.
                                                            3 of 21 CNISP CVC-BSI protocol Dec 22-05
If successful, this network could be expanded to include interested non-CNISP hospitals The benefit
for participating centers would be support in establishing uniform methods of data collection, training of
personnel where necessary, and the ability to compare individual hospital data with percentiles in a
Canadian database.
PLEASE NOTE THAT SURVEILLANCE FOT CVC-ASSOCIATED BSI IN HAEMATOPOEIETIC
STEM CELL TRANSPLANT RECIPIENTS (HSCT) HAS BEEN ADDED TO THIS PROTOCOL. SEE
ANNEX C.


METHODS:

Eligibility to participate:

1. Hospitals which are part of the CNISP network
2. Ability to perform surveillance for BSI in ICU 1 for at least 6 months of the year.
   - ICU with ≤ 5 beds must perform surveillance for the full 12 months. (15,16).
   - ICU participating in the Case-Control study (see separate protocol) must perform surveillance for
     the full 12 months, regardless of size.
3. Ability to document ICU-specific CVC 2 -days and ICU-specific patient-days for this same time
   period.
4. Able to collect and submit the above data by administrative periods of 12 weeks or 3 months.


Patient population:

All ICU patients in participating CNISP hospitals who have at least one CVC, whether the catheter was
inserted in the ICU or was already present on admission.


Surveillance period:

Surveillance will start January 1, 2006 and be performed for a period of 13 months (or at least 6
months for ICU with > 5 beds), with reassessment at one year as to the feasibility of and the need for a
continuous CNISP surveillance program.



1
  ICU is defined as a nursing care area in an acute care hospital that provides intensive observation, diagnostic and
supportive care to critically ill patients including, but not limited to, invasive intravascular hemodynamic monitoring,
endotracheal intubation and mechanical ventilation. The type of ICU is determined by the service designation of the majority
(e.g. >80%) of patients cared for by the unit. Bone marrow transplant units and units that provide step-down care,
intermediate care or telemetry only are excluded (16,17).
2
 CVC is a venous access device that terminates at or close to the heart or one of the great vessels. The CDC National
Healthcare Safety Network (NHSN) which is replacing NNIS, defines great vessels as: aorta, pulmonary artery, superior
vena cava, inferior vena cava, brachiocephalic, internal jugular, subclavian, external iliac and common femoral veins, and
umbilical artery and vein.
CVC include non-tunnelled (standard) CVC, whether coated or not, peripherally inserted CVC (PIC), tunnelled devices (e.g.
Broviac, Hickman, tunnelled haemodialysis line, etc) and umbilical artery and vein catheters. Totally implanted devices such
as Ports are NOT included. Pulmonary artery catheters are included as these are inserted via a central vein. Other arterial
catheters are NOT included (17). Pacemaker leads and other non-infusion devices inserted into central blood vessels or the
heart are NOT included (16).
                                                                     4 of 21 CNISP CVC-BSI protocol Dec 22-05
Denominators:

1. CVC-days:
   For each ICU: number of patients with one or more CVC each day, cumulated by 12 week or 3
   month administrative period (same interval as used for BSI surveillance).

     a. All except neonatal ICU:
        Count and record the number of patients with one or more CVC each day (“patients with CVC“
        are counted, NOT “CVC”; i.e. a patient with more than one CVC simultaneously counts as only
        one CVC-day) (see sample denominator data collection sheet in annex).

     b. Neonatal ICU:

        Neonatal ICU BSI rates will be stratified by birth weight group (≤1000g, 1001-1500g,1501-
        2500g,>2500g) . This stratification makes collection of CVC-days neonatal ICU more time-
        consuming. There are two suggested options for collecting this data:

        -   NNIS method: count number of patients of each birth weight group in the NICU and the
            number of patients of each birth weight group with CVC each day (see NNIS denominator
            data collection sheet for neonatal ICU in annex).

        -   Alternative: track individual patients from admission to discharge from ICU; for each patient
            note birthweight, date of CVC insertion (or date of admission if CVC present on admission)
            and date of CVC removal (or date of discharge from ICU or death in ICU if CVC not
            removed). (see alternative CVC denominator data collection sheet in annex).
            This method takes less time than the NNIS method, as birth weights need be checked only
            once

2.    Patient-days:
      For each ICU: Record number of patient-days by 12 week or 3 month administrative period
      (same interval used as for CVC-days). (see sample denominator data collection sheet in annex).

      For neonatal ICU: stratify patient-days by birth weight group (as described above) if possible.
      If data on patient-days by birth weight group are not available, report total neonatal patient days
      for the administrative period instead. (This information is not required for calculation of infection
      rates but is used for calculation of rate of CVC utilization per ICU (see calculations below) . For
      centres unable to supply patient-days by birth weight group, CVC-utilization rates will be
      calculated for the NICU but not stratified for birth weight)




                                                             5 of 21 CNISP CVC-BSI protocol Dec 22-05
Case definition:

BSI:

1. Recognised pathogen cultured from one or more blood cultures, unrelated to infection at another
   site.

    OR

2. At least one of: fever >38°C, chills, hypotension (if aged < 1 yr: one of fever >38°C, hypothermia,
   apnea, or bradycardia), or signs of infection of catheter insertion site, tunnel or pocket
     AND
         Common skin contaminant (eg diphtheroids, Bacillus spp, Propionibacterium spp coagulase
         negative staphylococci, or micrococci) cultured from two or more blood cultures drawn from
         separate sites or on separate occasions (i.e. from different venipunctures, no minimal time
         interval).

    OR

3. At least one of: fever >38°C, chills, hypotension (if aged < 1 yr: one of fever >38°C, hypothermia,
   apnea, or bradycardia), or signs of infection of catheter insertion site, tunnel or pocket
     AND
         Common skin contaminant (as above) cultured from one blood culture from a patient with an
         intravenous line and the physician institutes appropriate antimicrobial therapy.

Relapse vs new infection:

Same microorganism (as best as can be determined by the data available – e.g. species, antibiotic
sensitivity, etc) isolated from a subsequent blood culture:
   - If less than 10 days from a negative culture OR less than 10 days from completion of
        appropriate antibiotic therapy, consider as a relapse and DO NOT REPORT.
   - If more than 10 days from a negative culture (if culture was done) and more than 10 days from
        completion of appropriate antibiotic therapy, REPORT as a NEW infection.

ICU-associated BSI:

    BSI not present on admission to ICU. The patient must have been in the ICU for 48 hours for the
    BSI to be considered nosocomail, unless compelling evidence suggests the infection was
    nosocomial.
    BSI onset during ICU stay or within 48 hours of leaving ICU (17)

CVC-associated BSI:

    CVC- associated if catheter in place at onset of BSI or within the 48 hours before the onset of BSI
    (if CVC removed >48 hours before onset there must be compelling evidence that the infection was
    associated with the CVC) (17)

Case-finding:

Identification of patients with BSI:
                                                          6 of 21 CNISP CVC-BSI protocol Dec 22-05
  -   Daily (or, as a minimum, three time weekly) review of microbiology laboratory results.
  -   For each positive blood culture: determine if patient is in ICU or was in ICU within the 48 hours
      prior to the time the specimen was obtained.
  -   If so, review patient’s chart to determine if a CVC was present at the time the specimen was
      obtained or within the preceding 48 hours.
  -   If so, determine if case definition for CVC-associated BSI is met
  -   If so, fill the case data collection form
  -   Follow-up at one month to determine outcome and finalize the data collection form

Case descriptive data:

Cases are to be identified by a 8 digit unique number comprised of year (eg 06), CHEC site number
(eg 18A) and sequential patient number (eg 001).
As a patient may have more than one episode of CVC-associated BSI during the same ICU admission,
sequential episodes are to be identified by letter (a, b, etc)

Minimum dataset: Birthdate*
                          (age at first positive blood culture will be calculated for analysis in weeks if < 1
                          month, months if 1 month to < 5 years, years thereafter)
                    For neonatal ICU: Birth weight*
                    Sex*
                    Date of first positive blood culture *
                    Type of ICU* (eg, adult medical, surgical, coronary, mixed, pediatric, neonatal,
                    other)
                    Number of positive blood cultures (1 or ≥2) *
                    Criteria for diagnosis of CVC-associated BSI
                    Organism(s) isolated*
                    Antibiotic resistance: identify if MRSA, VRE, ESBL
                    Outcome at 30 days*: Discharged, still in hospital, or deceased in hospital.
                                           If deceased, relation to BSI: direct or indirect (contributing)
                                           cause of death, unrelated, or unable to assess
Several (*) of the above items of the dataset are also collected for the case control study.


ICU and hospital descriptive data:

Data will be collected using a hospital profile questionnaire filled early in the surveillance project and
repeated at one year to determine if significant changes have occurred.

Minimum data: Type(s) of ICU (eg. adult medical, surgical, coronary, mixed, pediatric, neonatal,
              other)
              Size of each ICU (by number of beds)
              Size of hospital (by number of acute care beds)
                 Teaching vs non-teaching hospital
                 Specialty hospital (eg, pediatric, trauma center etc)

If available:    Average number of ICU beds staffed per administrative block (for each ICU)
                 Average number of ICU beds occupied per administrative block (for each ICU)
                 Average nurse / patient ratio per administrative block (for each ICU)
                 Average ICU nursing workload score per administrative block (for each ICU)
                                                              7 of 21 CNISP CVC-BSI protocol Dec 22-05
Ethics:

This surveillance project is observational and does not involve any alteration in patient care.
Surveillance for nosocomial infections is a routine component of quality assurance and patient care in
Canadian health care institutions and therefore informed consent will not be required.
The major ethical issue is maintenance of patient confidentiality. Case data collection forms will be
identified with a unique number but no personal identifiers. Each local site will keep the link between
this number and the patient name and will not transmit this information to CNISP. Only cumulated
denominator data will be submitted. All data will be strictly confidential and maintained in locked
cabinets in secure sites.

Public access to individual CNISP site data:

There is current demand for public disclosure of hospital-associated adverse events. CNISP
participants should anticipate that they may be approached to release hospital-specific data, especially
if the results of this surveillance are published. Hospital administrators should be made aware that
national reporting will be occurring.

WORKLOAD:

Cases:          Review of microbiology laboratory blood culture results
                Determining location of patients with positive cultures
                Chart review to determine if patient fulfills criteria for CVC-BSI
                Filling of the case data collection form
                Assessing outcome at 4 weeks (mortality)

Denominators:           Daily collection of CVC-days if performed by ICP
                Collation of data on CVC-days collected by ICU personnel or by ICP
                Collection of data on patient-days

                For neonatal ICU doing birth weight stratification:
                Daily collection of data on CVC-days and patients-days if performed by ICP
                Collation of data on CVC-days and patient-days if data collected by neonatal ICU
                personnel

Hospital profile:      Filled twice a year




                                                             8 of 21 CNISP CVC-BSI protocol Dec 22-05
REFERENCES
1. Centers for Disease Control and Prevention. Guidelines for the prevention of intravascular
    catheter-related infections [Erratum to p. 29, Appendix B published in MMWR Vol. 51, No. 32, p.
    711]. MMWR 2002;51(No. RR-10):1-32.
2. Crnich CJ, Maki DG. Intravascular Device Infections. Chapter 24 In: Association for Professionals
    in Infection Control and Epidemiology (eds), APIC Text of Infection Control and Epidemiology.
    2004 pp 24-1 – 24-26.
3. Pittet D, Tarara D, Wenzel RP. Nosocomial bloodstream infection in critically ill patients. JAMA
    1994;271:1598-1601
4. NNIS System, Division of Healthcare Quality Promotion, National Center for Infectious Diseases,
    Centers for Disease Control and Prevention. National Nosocomial Infections Surveillance (NNIS)
    system report, data summary from January 1992 through June 2004, issued October 2004. AJIC
    2004;32:470-85.
5. Crnich CJ and Maki DG. The promise of novel technology for the prevention of intravascular
    device-related bloodstream infection. I. Pathogenesis and short-term devices. Clinical Infect Dis
    2002;34:1232-42.
6. Fridkin SK, Pear SM, Williamson TH, Galgiani JN, Jarvis WR. The role of understaffing in central
    venous catheter-associated bloodstream infections. Infect Control Hosp Epidemiol 1996;17:150–8.
7. Zuschneid I, Schwab F, Geffers C, Ruden H, Gastmeier P. Reducing central venous catheter-
    associated primary bloodstream infections in intensive care units is possible: Data from the
    German nosocomial infection surveillance system. Infect Control Hosp Epidemiol 2003;24:501-505.
8. Centers for Disease Control and Prevention. Monitoring hospital-acquired infections to promote
    patient safety - United States, 1990-1999. (erratum in MMWR 49;189). MMWR 2000;49:149-53.
9. Coello R, Charlett A, Ward V, Wilson J, Pearson A, Sedgwick J, Borriello P. Device-related sources
    of bacteraemia in English hospitals--opportunities for the prevention of hospital-acquired
    bacteraemia. J Hosp Infect 2003;53:46-57
10. Memish ZA, Arabi Y, Cunningham G, Kritchevsky S, Braun B, Richards C, Weber S,Pereira CR,
    EPIC Group. Comparison of US and non-US central venous catheter infection rates: evaluation of
    processes and indicators in infection control study. Am J Infect Control 2003 31:237-42.
11. Holton D, Paton S, Conly J et al. Central venous catheter-associated blood stream infections
    occurring in Canadian intensive care units: A six month cohort study (2005, draft for submission).
12. Tremblay C, Moore DL, Meunier L, Bourgault A-M, Leduc L, Frenette C, et le groupe de
    surveillance provinciale des infections nosocomiales (SPIN-QUEBEC). Multicenter surveillance of
    nosocomial bloodstream infections in Quebec: Infections associated with central vascular catheters
    in intensive care units. Fifth International Conference of the Hospital Infection Society, Edinburgh,
    Sept 15-18, 2002.
13. Frenette C. La deuxième etude des bactériémies nosocomiales au Québec. L’AMMIQale
    2002;10:77-79.
14. Surveillance provinciale des infections nosocomiales (SPIN). Rapport de la surveillance provinciale
    des bactériémies nosocomials sur cathéters centraux aux soins intensifs. October 2005. (personal
    communication)
15. Healthcare Infection Control Practices Advisory Committee. Recommendations of the Healthcare
    Infection Control Practices Advisory Committee: Guidance on public reporting of healthcare-
    associated infections. Atlanta, GA. Centers for Disease Control and Prevention, Feb 28, 2005. pp
    1-31. http://www.cdc.gov/ncidod/hip/PublicReportingGuide.pdf
16. McKibben L, Horan T, Tokars JI, Fowler G, Cardo DM, Pearson ML, Brennan PJ; Heathcare
    Infection Control Practices Advisory Committee. Guidance on public reporting of healthcare-
    associated infections: recommendations of the healthcare infection control practices advisory
    committee. Am J Infect Control 2005 May;33:217-26.
17. Horan TC, Emori TG. Definition of key terms used in the NNIS system. AJIC 1997:25:112-116.
                                                          9 of 21 CNISP CVC-BSI protocol Dec 22-05
18. National Nosocomial Infections Surveillance. CDC definitions for nosocomial infections 2004
   http://www.cdc.gov/ncidod/hip/Surveill/NNIS.HTM accessed Oct 15, 2005
19. Health Canada. Preventing Infections Associated with Indwelling Intravascular Access Devices.
    Canada Communicable Disease Report 1997; 23S8.




                                                       10 of 21 CNISP CVC-BSI protocol Dec 22-05
             ANNEX B:    ICU Denominator data collection forms        (examples)

CNISP site number         __________
Administrative period ________ to ___________
ICU (circle) : Adult:     Medical, Surgical, Coronary care, Mixed, Other__________
                    Pediatric

January 2006                   # patients *      # patients with one or more
                                                             CVC
Jan     1
        2
        3
        4
        5
        6
        7
        8
        9
        10
        11
        12
        13
        14
        15
        16
        17
        18
        19
        20
        21
        22
        23
        24
        25
        26
        27
        28
        29
        30
        31
Total                      patient-days* =     CVC-days =

* in some hospitals this data may be more easily obtained by administrative period from
hospital admitting databases than by noting number of patients each day.

                                                   11 of 21 CNISP CVC-BSI protocol Dec 22-05
                    ANNEX B:      ICU Denominator data collection forms

Denominator data collection form for neonatal ICU (stratification by birth weight group)

CNISP site number           __________ Administrative period ________ to
     ___________

          BW ≤ 1000 g        BW 1001-1500 g           BW 1501-2500 g            BW >2500 g
Jan
2006   # patients      #     # patients        #     # patients        #     # patients        #
           *       patients      *         patients      *         patients      *         patients
                  with CVC                with CVC                with CVC                with CVC
                  (including              (including              (including              (including
                   UA , UV)                UA, UV)                 UA , UV)                UA , UV)
1      ______     ______     ______       ______     ______       ______    _______       ______
       _          _          _            _          _            _                       _
2      ______     ______     ______       ______     ______       ______    _______       ______
       _          _          _            _          _            _                       _
3      ______     ______     ______       ______     ______       ______    _______       ______
       _          _          _            _          _            _                       _
4      ______     ______     ______       ______     ______       ______    _______       ______
       _          _          _            _          _            _                       _
5      ______     ______     ______       ______     ______       ______    _______       ______
       _          _          _            _          _            _                       _
6      ______     ______     ______       ______     ______       ______    _______       ______
       _          _          _            _          _            _                       _
7      ______     ______     ______       ______     ______       ______    _______       ______
       _          _          _            _          _            _                       _
8      ______     ______     ______       ______     ______       ______    _______       ______
       _          _          _            _          _            _                       _
9      ______     ______     ______       ______     ______       ______    _______       ______
       _          _          _            _          _            _                       _
10     ______     ______     ______       ______     ______       ______    _______       ______
       _          _          _            _          _            _                       _
11     ______     ______     ______       ______     ______       ______    _______       ______
       _          _          _            _          _            _                       _
12     ______     ______     ______       ______     ______       ______    _______       ______
       _          _          _            _          _            _                       _
13     ______     ______     ______       ______     ______       ______    _______       ______
       _          _          _            _          _            _                       _
14     ______     ______     ______       ______     ______       ______    _______       ______
       _          _          _            _          _            _                       _
15     ______     ______     ______       ______     ______       ______    _______       ______
       _          _          _            _          _            _                       _
16     ______     ______     ______       ______     ______       ______    _______       ______
       _          _          _            _          _            _                       _

                                                        12 of 21 CNISP CVC-BSI protocol Dec 22-05
17       ______      ______       ______      ______       ______      ______       _______       ______
         _           _            _           _            _           _                          _
18       ______      ______       ______      ______       ______      ______       _______       ______
         _           _            _           _            _           _                          _
19       ______      ______       ______      ______       ______      ______       _______       ______
         _           _            _           _            _           _                          _
20       ______      ______       ______      ______       ______      ______       _______       ______
         _           _            _           _            _           _                          _
21       ______      ______       ______      ______       ______      ______       _______       ______
         _           _            _           _            _           _                          _
22       ______      ______       ______      ______       ______      ______       _______       ______
         _           _            _           _            _           _                          _
23       ______      ______       ______      ______       ______      ______       _______       ______
         _           _            _           _            _           _                          _
24       ______      ______       ______      ______       ______      ______       _______       ______
         _           _            _           _            _           _                          _
25       ______      ______       ______      ______       ______      ______       _______       ______
         _           _            _           _            _           _                          _
26       ______      ______       ______      ______       ______      ______       _______       ______
         _           _            _           _            _           _                          _
27       ______      ______       ______      ______       ______      ______       _______       ______
         _           _            _           _            _           _                          _
28       ______      ______       ______      ______       ______      ______       _______       ______
         _           _            _           _            _           _                          _
29       ______      ______       ______      ______       ______      ______       _______       ______
         _           _            _           _            _           _                          _
30
31       ______      ______       ______      ______       ______      ______       _______       ______
         _           _            _           _            _           _                          _
* in some hospitals this data may be more easily obtained by administrative period from hospital admitting or
NICU databases than by noting number of patients each day. If number of patients by birth weight group not
available, report total number of patients. Number of patients with CVC must be stratified by birth weight group.




                                                               13 of 21 CNISP CVC-BSI protocol Dec 22-05
                           ANNEX B: ICU Denominator data collection forms

Alternative denominator data collection form for neonatal ICU:
(Alternative method for stratification by birth weight group: tracking individual patients;
advantage = only need to check birth weight of each patient once)
- Each neonatal ICU admission is listed, along with birth weight. If patient admitted or transferred in more than
  once, list each admission on a separate line
- For patients present at onset of surveillance program: Date of admission replaced by surveillance start date
- For patients present at end of surveillance program: Date of discharge replaced by surveillance end date
- For CVC present at onset of surveillance program: Date of insertion replaced by surveillance start date
- For CVC present at end of surveillance program: Date of removal replaced by surveillance end date
- At end of surveillance period, count number of CVC-days and number of patient-days.
- Only the cumulated data (total CVC-days and total patient-days for 3 month or 12 week administrative period)
  is to be submitted to CNISP.

- If number of patients by birth weight group not available, report total number of patients. Number of patients
  with CVC must be stratified by birth weight group

    (in example below: “adm” = day admitted; “disch” = day discharged;“ y” = CVC present
 Period: Jan 1–
 14:
 Date:                 1      2    3      4     5     6     7      8     9       10     11    12    13      14
 name / hosp no.       ad                                                disch
 Birthweight           m
 CVC                          y    y      y
                       y
 name / hosp no.
 Birthweight
 CVC                   y      y    y      y     y     y     y      Y     y       y      y     y     y       y
 name / hosp no.       ad                                                                           disch
 Birthweight           m
 CVC                          y                       y     y      Y     y
                       y
 name / hosp no.                          ad                             disch
 Birthweight                              m
 CVC

 name / hosp no.                                ad
 Birthweight                                    m
 CVC                                                  y     y                                 y     y       y
                                                y
 name / hosp no.                                      ad
 Birthweight                                          m
 CVC
 name / hosp no.                                                         adm                                disch
 Birthweight
 CVC                                                                             y      y
 name / hosp no.                                                                        ad
 Birthweight                                                                            m
 CVC                                                                                          y     y       y
                                                                                        y


                                                                14 of 21 CNISP CVC-BSI protocol Dec 22-05
CVC days for this 2 week period:
BW: ≤ 1000 g: ____ 1001-1500 g ___ 1501 - 2500 g ___ >2500 g ____ Total _____
Patient-days for this 4 week period:
BW: ≤ 1000 g: ____ 1001-1500 g ___ 1501 - 2500 g ___ >2500 g ____ Total _____




                                                  15 of 21 CNISP CVC-BSI protocol Dec 22-05
ANNEX C:

            CVC-BSI IN HAEMATOPOEIETIC STEM CELL TRANSPLANT RECIPIENTS

Surveillance for CVC-BSI in patients undergoing haematopoeietic stem cell transplant (HSCT) has
been added to this project.

Patients undergoing HSCT are at high risk for CVC-BSI (1-4). Tunnelled cuffed catheters, totally
implanted ports and peripherally inserted central catheters are frequently used in this population.
These devices are generally associated with a lower infection rate than short term nontunnelled
percutaneoulsy inserted CVC (4). Infection rates with totally implanted devices are particularly low.
Although pediatric patients undergoing HSCT frequently have totally implanted devices in place,
additional access devices are usually installed for the period of transplantation.

There is less data published on CVC-BSI rates in this population. Type of catheter, patient risk factors
such as age, underlying disease, conditioning regimen, duration of neutropenia, and surveillance
methods used influence results. HSCT patients are usually discharged with CVC in place, and duration
of surveillance may be continued until neutrophil engraftment, until discharged, or until CVC is
removed. Rates of 16 and 6.7 BSI per 1000 CVC-days have been reported in HSCT patients in
hospital (2,5). In a pediatric study, rate per 1000 CVC-days was 5.5 while in hospital and 1.7 while at
home (6).

REFERENCES:
  1. Centers for Disease Control and Prevention. Guidelines for the prevention of intravascular
     catheter-related infections [Erratum to p. 29, Appendix B published in MMWR Vol. 51, No. 32,
     p. 711]. MMWR 2002;51(No. RR-10):1-32.
  2. Marena C, Zecca M, Carenini ML, Bruschi A, Bassi ML, Olivieri P, Azzaretti S, Locatelli F.
     Incidence of, and risk factors for, nosocomial infections among hematopoietic stem cell
     transplantation recipients, with impact on procedure-related mortality. Infect Control Hosp
     Epidemiol. 2001;22:510-7.
  3. Dettenkofer M, Ebner W, Bertz H, Babikir R, Finke J, Frank U, Ruden H, Daschner FD.
     Surveillance of nosocomial infections in adult recipients of allogeneic and autologous bone
     marrow and peripheral blood stem-cell transplantation. Bone Marrow Transplant. 2003;31:795-
     801.
  4. Crnich CJ and Maki DG. The promise of novel technology for the prevention of intravascular
     device-related bloodstream infection. I. Pathogenesis and short-term devices. Clinical Infect Dis
     2002;34:1232-42.
  5. Keung YK, Watkins K, Chen SC, Groshen S, Levine AM, Douer D. Increased incidence of
     central venous catheter-related infections in bone marrow transplant patients. Am J Clin Oncol.
     1995;18:469-74.
  6. Uderzo C, D'Angelo P, Rizzari C, Vigano EF, Rovelli A, Gornati G, Codecasa G, Locasciulli A,
     Masera G. Central venous catheter-related complications after bone marrow transplantation in
     children with hematological malignancies. Bone Marrow Transplant. 1992;9:113-7.




                                                          16 of 21 CNISP CVC-BSI protocol Dec 22-05
                                               PROTOCOL:

Eligibility to participate:

1. Hospitals which are part of the CNISP network and that perform HSCTs at their facility or receive in
   transfer patients who underwent HSCT at another CNISP hospital.
2. Ability to perform surveillance for CVC-BSI in HSCT recipients for one year (February 1, 2006 -
   February 1, 2007).
3. Ability to document CVC-days for all HSCT recipients under surveillance for this same time period.

Patient population:

   All patients undergoing inpatient or outpatient HSCT between February 1, 2006 and February 1,
   2007 in participating CNISP hospitals and who have a CVC will be followed for 90 days from the
   date of transplant or until final CVC removal, whichever comes first.

Denominators:

   CVC-days:
   Patients will be enrolled on the date of their HSCT and followed until a CVC is no longer in place,
   or for 90 days, whichever is first. All line insertions within the first 90 days are to be included. Only
   those days where an eligible CVC was in place is included in the denominator as a CVC-day.
   As an example: a patient undergoes HSCT 48 hours after Hickman line placement. He is enrolled
   on the date of the HSCT. His Hickman falls out at day 35 and is reinserted at day 40. The line is
   removed on day 70 but another placed on day 85 and still in place on day 90 post-HSCT. This
   patient has 70 CVC-days before follow-up is discontinued at day 90. Another patient undergoes
   HSCT 5 days after PICC insertion. Her line is removed at day 48 and no further CVCs inserted.
   This patient has 48 CVC-days before follow-up is discontinued as per protocol.

   For definition of CVC, see CVC-BSI protocol. Totally implanted devices (ports) are NOT included.

Case definitions:

   As for CVC-BSI in ICU

Case-finding:

       Review of microbiology laboratory reports three times a week for positive blood cultures.
       For each positive blood culture: determine if patient has received HSCT within the previous 90
       days
       If so, review chart to determine if case definition for CVC-BSI is met.
       If so, fill the case data collection form and find a control.
       Follow-up at one month to determine outcome and finalize the data collection form.

       See also Protocol for case-control project “Outcomes and risk factors for central venous
       catheter related bloodstream infections in critical care and haematopoietic stem cell
       transplant patients hospitalized in Canadian acute care hospitals.




                                                           17 of 21 CNISP CVC-BSI protocol Dec 22-05
Rate calculations:

      Infection rate:
                                     Number of CVC-associated BSIs
      CVC-associated BSI rate =                                      X 1000
                                         Number of CVC-days

      Rates will be calculated for each center

      Numerators and Denominators) from participating centers will be pooled to calculate pooled
      mean infection rates:
            Rates will be calculated separately for age groups < 2 yrs, 2-5 yrs, 5-18 yrs and >18 yrs.

             Rates will be calculated separately for tunnelled CVC, peripherally-inserted CVC and
      other CVC


HSCT CASE DATA COLLECTION REPORT FORM: see case control study protocol and data
     collection form




                                                          18 of 21 CNISP CVC-BSI protocol Dec 22-05
       ANNEX D :   HSCT DENOMINATOR DATA COLLECTION FORM

       HSCT Recipient Log

Name         Hospital No.   CHEC No.   HSCT Date     Type of CVC:       Start date:    End date:   CVC-BSI        Outcome
                                       MM/DD/YY    Tunn   PICC Other   MM/DD/YY       MM/DD/YY     Yes   No      Alive   Dead




                                                                            19 of 21 CNISP CVC-BSI protocol Dec 22-05
ANNEX E: NNIS and CHEC 1997 CVC-associated BSI definitions (for information only)

NNIS:

NNIS Surveillance definitions: Laboratory-confirmed BSI (BSI-LCBI): (1,18)

 - Recognised pathogen cultured from one or more blood cultures and not related to infection at
   another site
 OR
 - At least one of: fever >38°C, chills, hypotension, (if aged < 1 yr, at least one of: fever >38°C,
   hypothermia <37°C, apnea, or bradycardia)
   AND at least one of:
       Common skin contaminant (eg diphtheroids, Bacillus spp, Propionibacterium spp, coagulase-
       negative staphylococci, micrococci) cultured from two or more blood cultures drawn on
       separate occasions
       or
       Common skin contaminant (eg diphtheroids, Bacillus spp, Propionibacterium spp, coagulase-
       negative staphylococci, micrococci) cultured from at least one blood culture from a patient with
       an intravascular line and the physician institutes appropriate antimicrobial therapy.
       (Positive antigen test on blood -Haemophilus influenzae Streptococcus pneumoniae, Neisseria
       meningitidis, group B Streptococcus included in BSI-LCBI but not relevant to CVC-BSI)

NNIS Surveillance definitions: Catheter-Associated BSI: (1)
Patient with:
 - A vascular access device that terminates at or close to the heart or one of the great vessels. An
    umbilical artery or vein catheter is considered a central line
 - BSI is considered to be catheter-associated if CVC used during the 48 hours before the
    development of the BSI. If the time interval between device use and onset of infection is >48 hours,
    there must be compelling evidence that the infection was related to the central line.

NNIS: ICU-associated (17).

BSI not present on admission to ICU but became apparent during ICU stay or within 48 hours of
leaving ICU

CNISP:    CVC-BSI surveillance protocol 1996 (19).

Definite:
   Pathological and/or microbiological confirmation of septic thrombophlebitis from a surgically
   resected vein or artery within which a catheter or device had been placed, with a positive blood
   culture
or
   A single positive peripheral blood culture from a patient with clinical and microbiological data
   disclosing no other source of the bacteremia in the presence of a semiquantitative culture of a
   catheter segment (proximal or distal) from which the same organism (species, antibiogram) was
   isolated
or
   A single positive peripheral blood culture from a patient with isolation of the same organism
   (species, antibiogram) from purulent, serous or serosanguinous discharge from the catheter exit


                                                         20 of 21 CNISP CVC-BSI protocol Dec 22-05
   site or along the path of a subcutaneously tunnelled catheter or from the subcutaneous pocket
   containing a reservoir of a totally implantable device

Probable:
   Two or more positive blood cultures of the same organism (species, antibiogram) from any source
   (peripheral or retrograde intravascular device cultures) from a patient with clinical and
   microbiological data disclosing no other source for the bacteremia except the intravascular device.
or
   One positive blood culture of S. aureus or Candida from any site in a patient with clinical and
   microbiological data disclosing no other source for the bacteremia except the intravascular device.
or
   One positive blood culture for any organism commonly associated with intravascular device-related
   infection (coagulase negative staphylococci, Bacillus sp, Corynebacterium sp, Enterococcus sp,
   Trichophyton sp or Malassezia furfur) in immunocompromised patient or a neutropenic patient
   (neutrophils <0.5 x 109/L), or a neonate or patient receiving TPN with clinical and microbiological
   data disclosing no other source for the bacteremia except a centrally placed intravascular device. *

Possible
   One positive blood culture for organisms other than S. aureus or Candida species from any site in
   any patient not included in the list above, with clinical and microbiological data disclosing no other
   source for the bacteremia except a central intravascular device and does not fit criteria for
   probable.*


* Quebec CVC-associated BSI surveillance: (current definition)
   As CNISP 1996 except eliminated “in immunocompromised patient or a neutropenic patient
   (neutrophils <0.5 x 109/L), or a neonate or patient receiving TPN” and added: “physician institutes
   appropriate antibiotic therapy”; also eliminated “possible” group.




                                                          21 of 21 CNISP CVC-BSI protocol Dec 22-05

				
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