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
Abstract
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.
Results
N=179
Table: Summary of C. diff Hospital Survey 2010
Number Percent
Is C. diff testing outsourced to an external laboratory?
Yes
No
35
144
19.6
80.4
Yes
No
46
132
25.8
74.2
Yes
No
106
68
60.9
39.1
Does the lab routinely perform tests on formed stool specimens? (No answer = 1)
Does the lab have a rejection policy for duplicate stool specimens? (No answer = 5)
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
The 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.
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.
New York State Dept. of Health, HAI Reporting Program
What is the primary test method the lab uses to detect C. diff? (No answer = 4)
Toxin A and B antibody (ELISA or EIA)
PCR
Glutamate dehydrogenase (GDH) or common antigen
Toxin A antibody only (ELISA or EIA)
Cytotoxin (CXT) assay (Toxin B)
Anaerobic microbiology culture
Is confirmatory test performed for equivocal test results? (No answer = 8)
Yes
Repeat primary test
PCR
GDH or common antigen
Tissue culture
No
If not currently using a PCR test method, is there consideration for use? (No answer = 9)
No
Yes, start date identified
Yes, start date unknown
146
19
5
3
2
0
83.4
10.9
2.9
1.7
1.1
0.0
93
76
11
4
2
78
n=160
103
7
41
54.4
81.7
11.8
4.3
2.2
45.6
68.2
4.6
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.
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.
Reference
Note: The 2007-2009 New York State Hospital-Acquired Infection Reports can be found at:
www.nyhealth.gov/nysdoh/hospital/reports/hospital_acquired_infections.
The 2010 Report is expected to be released September 2011.
1Gerding
DN, Johnson S, Peterson LR, Mulligan ME, Silva J Jr. Clostridium difficile-associated diarrhea and colitis.
Infect Control Hosp Epidemiol. 1995;16(8):459-477.
No financial disclosures.