Background

1
New York State Department of Health Mandatory
Reporting of Clostridium difficile via NHSN LabID
Event Survey to Determine Testing Methods and
Laboratory Policies
Kathleen A. Gase, MPH, CIC, KuangNan Xiong, BS,
Johanna B. Lee, MPH, MA, Valerie Haley, MS, Boldt
Tserenpuntsag, DrPH, Diana Doughty, RN, MBA, CIC,
CPHQ, Peggy Hazamy, RN, BSN, CIC, Rachel Stricof,
MPH, CIC, Marie Tsivitis, MPH, CIC, Victor Tucci,
MPH, CIC, ASCP, Carole Van Antwerpen, RN, BSN, CIC
New York State Dept. of Health, HAI Reporting
Program
Abstract
Results
Table Summary of C. diff Hospital Survey 2010 N179
Number Percent
Is C. diff testing outsourced to an external laboratory?
Yes 35 19.6
No 144 80.4
Does the lab routinely perform tests on formed stool specimens? (No answer 1)
Yes 46 25.8
No 132 74.2
Does the lab have a rejection policy for duplicate stool specimens? (No answer 5)
Yes 106 60.9
No 68 39.1
What is the primary test method the lab uses to detect C. diff? (No answer 4)
Toxin A and B antibody (ELISA or EIA) 146 83.4
PCR 19 10.9
Glutamate dehydrogenase (GDH) or common antigen 5 2.9
Toxin A antibody only (ELISA or EIA) 3 1.7
Cytotoxin (CXT) assay (Toxin B) 2 1.1
Anaerobic microbiology culture 0 0.0
Is confirmatory test performed for equivocal test results? (No answer 8)
Yes 93 54.4
Repeat primary test 76 81.7
PCR 11 11.8
GDH or common antigen 4 4.3
Tissue culture 2 2.2
No 78 45.6
If not currently using a PCR test method, is there consideration for use? (No answer 9) n160
No 103 68.2
Yes, start date identified 7 4.6
Yes, start date unknown 41 27.2
Out of 179 (100 response rate) hospitals ?
144 (80.4) perform their own C. diff tests vs.
outsourcing to an external laboratory (35,
19.6) ? 146 (83.4) use Toxin A and B
antibody (ELISA or EIA) as their primary test
method 19 (10.9) use PCR 10 (5.7) use a
different method 4 hospitals did not respond
? Of the 151 hospitals not currently using
PCR as their primary test method, 48 (31.8) are
considering its use. However, only 7
(14.6) have identified a start date for PCR
use ? 132 (74.2) do not routinely perform
tests on formed stool specimens ?
Positive results from formed stools are supposed
to be excluded for NHSN and NYS reporting
purposes ? 106 (60.9) have a rejection
policy for duplicate stool specimens and ?
93 (54.4) perform a confirmatory test for an
equivocal test result ? 76
(81.7) repeat primary testing method 11 (11.8)
perform PCR 6 (6.5) use other method.
Background In 2009, the Centers for Disease
Control and Prevention (CDC) introduced a module
in the National Healthcare Safety Network (NHSN)
allowing reporting of Clostridium difficile (C.
diff). Beginning July 1, 2009, New York State
(NYS) began using the LabID Event reporting
function to report facility-wide C. diff at all
NYS hospitals as part of the mandatory public
reporting law. Data collected in 2009 will be
used as pilot data and will not be reported to
the public by hospital. Objective Collect
baseline data regarding laboratory testing
policies and testing methods used by NYS
facilities to diagnose C. diff. Methods In May
2010, an on-line Survey Monkey tool was developed
and sent to 179 NYS facilities reporting C. diff
LabID Events to assess testing policies and
methods. All surveys were completed within one
month. Results 179 (100) hospitals responded to
the survey. See Table for results. Conclusions Th
e vast majority (80) of NYS facilities perform
their own C. diff tests the most common testing
method (82) is Toxin A and B antibody (ELISA or
EIA). Only 19 (11) facilities are using PCR
technology as their primary testing method an
additional 7 (4) facilities will begin using
PCR, and 41 (23) facilities are considering its
use.   Despite evidence against testing formed
stool or duplicate specimens1, many laboratories
do not have policies rejecting these specimens
(26 and 38, respectively).   NYS will continue
to survey facilities on a yearly basis to monitor
changes in testing methods and policies. It will
be important to monitor these factors and their
association with infection rates.
Conclusions
NYS will continue to survey facilities on a
yearly basis to monitor changes in testing
methods and policies. It will be important to
monitor these factors and their association with
infection rates. In future surveys, NYS will also
consider including questions regarding C.
difficile prevention policies and practices in
order to assess best practices across the
state. Overall, by May 2010, very few facilities
had made the switch to PCR testing for C.
difficile detection. As facilities make the
switch to the more sensitive PCR testing method,
NYS must ensure that facilities are fairly
compared in the annual public report. Changing
testing methods may also make it more difficult
to assess trends within a facility. Despite
evidence against testing formed stool or
duplicate specimens1, many laboratories do not
have policies rejecting these specimens for
those facilities with rejection policies, it is
unclear if these policies are enforced. This may
adversely affect the accuracy of rates reported
at these facilities. Currently, there is no
systematic method in place to verify the accuracy
of information collected in the survey this is a
consideration for future surveys and on-site
hospital audits.
Methods
? In May 2010, an on-line Survey Monkey tool was
developed and sent to all 179 NYS facilities
reporting C. diff LabID Events to assess testing
policies and methods. ? All surveys were
completed within one month. ? To ensure
100 response rate, facilities were notified via
e-mail and phone calls if they had not
completed the survey. ? All information was
captured via self-report by the facilities.
? There was no formal validation of this
information by NYSDOH.
Reference
1Gerding DN, Johnson S, Peterson LR, Mulligan ME,
Silva J Jr. Clostridium difficile-associated
diarrhea and colitis. Infect Control Hosp
Epidemiol. 199516(8)459-477.
Note The 2007-2009 New York State
Hospital-Acquired Infection Reports can be found
at www.nyhealth.gov/nysdoh/hospital/reports/hospi
tal_acquired_infections. The 2010 Report is
expected to be released September 2011.
No financial disclosures.