HAIC 400.8 Annual Survey of Laboratory Testing Practices for C. dif

Form Approved
OMB No. xxxxxx

Annual Survey of Laboratory Testing Practices
for C. difficile Infection
CDC’s Emerging Infections Program - Clostridioides difficile Infection Surveillance

Section 1: Laboratory Information
To be completed by surveillance officer
LABID#: _________________________
Completed By: _____________________________________
Date survey was completed: _____ /_____ /_____
Was this a new laboratory in 2024?
⃝ Yes
⃝ No
Year added to surveillance: ___________
Is this lab in another EIP site?
⃝ Yes
What state? ____________________
LabID in other EIP site: ____________________
⃝ No
Did this lab participate in surveillance in 2024?
⃝ Yes
⃝ No
How often did you receive line lists from this lab in 2024?
⃝ Whenever there is a positive case
⃝ Daily
⃝ Weekly
⃝ Monthly
⃝ Annually
⃝ Never
⃝ Other
Public reporting burden of this collection of information is estimated to average 19 minutes per response, including the time for reviewing instructions,
searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may
not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to
CDC/ATSDR Reports Clearance Officer; 1600 Clifton Road NE, MS D-74, Atlanta, Georgia 30329; ATTN: PRA (0920-0978).

Form Approved
OMB No. XXX-XXXX

Specify: __________________________

How did you receive line lists from this lab in 2024?
⃝ Electronic laboratory reporting (e.g. HL7 messaging)
⃝ Fax
⃝ Email
⃝ Mail
⃝ Secure file transfer
⃝ Other
Specify: __________________________
Did you receive specimens from this lab in 2024?
⃝ Yes
⃝ No
Was this lab audited in 2024?
⃝ Yes, in person
⃝ Yes, not in person
⃝ No, not in catchment
⃝ No, not audited
Specify reason: ________________________
Is this a private, commercial lab (e.g. Quest or LabCorp)?
⃝ Yes
⃝ No
Types of facilities in your catchment area served by this lab in 2024 (select all that apply):
⃝ Hospitals
⃝ LTACHs
⃝ LTCFs
⃝ Outpatient facilities

Form Approved
OMB No. XXX-XXXX

Section 2: Survey

To be completed by lab personnel
Instructions: This survey is intended to capture testing practices at your laboratory between January 1, 2024
and December 31, 2024.
Position of the staff who responded to the survey:
⃝ Laboratory Supervisor
⃝ Microbiology Supervisor
⃝ Other
Specify: ____________________

Offsite Testing
1. Did your laboratory ever send specimens off-site for Clostridioides difficile testing in 2024? (Choose one)
⃝ Always (no onsite testing performed)
LabID of Offsite Lab: ____________________
⃝ Regularly, as part of standard testing algorithm
LabID of Offsite Lab: ____________________
Which tests are done offsite, and at which point in the testing algorithm?
______________________________________
⃝ Not regularly, but when a test ordered by a physician cannot be performed onsite
Specify tests performed offsite: _________________________________
⃝ Never (All testing performed onsite)
⃝ Unknown
⃝ Other
Specify: __________________________

Form Approved
OMB No. xxxxxx

Testing Routine for CDI
2a. Which testing method(s) for Clostridioides difficile (C. difficile) did your laboratory perform in 2024? (Choose all that apply. Include testing
methods used for only part of the year or for only a specific subset of specimens, if applicable)
Did your laboratory
use this testing
method for
Clostridioides difficile
(C. difficile) in 2024?

GDH and EIA for toxin
simultaneously,
followed by NAAT for
discordant results
NAAT, followed by EIA
for toxin and GDH
simultaneously if
NAAT positive
NAAT, followed by EIA
for toxin if NAAT
positive

 Routinely
 Sometimes
 Never

Specify when you used
this test (e.g. at
provider request, for
outpatients, for
inpatients with a
length of stay > 3 days,
for every specimen
received)

Did you use this
testing method in this
way for all of 2024?

What date did you
change?

What test did you use
in this situation before
this date?

 Yes
 No

 Routinely
 Sometimes
 Never

 Yes
 No

 Routinely
 Sometimes
 Never

 Yes
 No

GDH, followed by
NAAT if GDH positive

 Routinely
 Sometimes
 Never

 Yes
 No

GDH and EIA for toxin
simultaneously,
followed by cell
cytotoxicity
neutralization assay
(cytotoxin)

 Routinely
 Sometimes
 Never

 Yes
 No

Public reporting burden of this collection of information is estimated to average 19 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining
the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a
currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Reports
Clearance Officer; 1600 Clifton Road NE, MS D-74, Atlanta, Georgia 30329; ATTN: PRA (0920-0978).

Form Approved
OMB No. XXX-XXXX

Did your laboratory
use this testing
method for
Clostridioides difficile
(C. difficile) in 2024?

Specify when you used
this test (e.g. at
provider request, for
outpatients, for
inpatients with a
length of stay > 3 days,
for every specimen
received)

Did you use this
testing method in this
way for all of 2024?

GDH and EIA for toxin
simultaneously

 Routinely
 Sometimes
 Never

 Yes
 No

EIA for toxin

 Routinely
 Sometimes
 Never

 Yes
 No

Cell cytotoxicity
neutralization assay
(cytotoxin)

 Routinely
 Sometimes
 Never

 Yes
 No

C. difficile-specific
NAAT (e.g., PCR,
LAMP)

 Routinely
 Sometimes
 Never

 Yes
 No

Multiplex GI panel
NAAT

 Routinely
 Sometimes
 Never

 Yes
 No

Toxigenic culture (C.
difficile culture
followed by detection
of toxins)
Other (specify):
__________________
__________________
__________________
__________

 Routinely
 Sometimes
 Never

 Yes
 No

 Routinely
 Sometimes
 Never

 Yes
 No

What date did you
change?

What test did you use
in this situation before
this date?

Form Approved
OMB No. xxxxxx

Testing Kits for CDI
3a. Which EIA test kit was used by your laboratory in 2024? (Check all that apply; see appendix for additional
examples)
□ Premier (Meridian) Toxins A & B
□ Premier (Meridian) Toxin A
□ Remel ProSpecT Toxins A & B
□ TechLab Toxins A & B
□ Inverness Medical/Wampole Toxins A & B QuikCheck
□ Inverness Medical/Wampole QuikCheck Complete (Toxins A & B and Antigen)
□ Antigen Testing
Specify antigen testing kit name/manufacturer: ____________________
□ Other
Specify other kit name/manufacturer: ____________________
□ N/A (Do not use EIA testing)
3b. Which Nucleic Acid Amplification test was used by your laboratory in 2024? (Check all that apply)
□ BD-GeneOhm C. difficile
□ BD MAX C. difficile
□ Cepheid Xpert C. difficile
□ Meridian Illumigene
□ Prodesse (Gen-Probe) Progastro CD
□ Luminex xTAG GPP
□ Biofire Filmarray GI Panel
□ Quidel AmpliVue C. difficile Assay
□ Great Basin Portrait Toxigenic C. difficile Assay
□ Nanosphere Verigene SP
□ Other
Specify other test: ____________________
□ N/A (Do not use nucleic acid amplification)

Public reporting burden of this collection of information is estimated to average 19 minutes per response, including the time for reviewing instructions,
searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may
not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to
CDC/ATSDR Reports Clearance Officer; 1600 Clifton Road NE, MS D-74, Atlanta, Georgia 30329; ATTN: PRA (0920-0978).

Form Approved
OMB No. XXX-XXXX

Multiplex GI panels
4a. If your laboratory used a multiplexed molecular diagnostic (e.g., Biofire Filmarray GI Panel, Luminex xTAG
GPP) to test for several GI pathogens in 2024, did your laboratory suppress the C. difficile result so that
clinicians could not see it?
□ Yes, C. difficile result is always suppressed
□ Yes, C. difficile result is suppressed at clinician request
□ Yes, C. difficile result is suppressed but laboratory will release the result upon clinician request
□ Yes, C. difficile result is suppressed in certain situations
Specify: ______________
□ No, clinicians always see C. difficile result
□ N/A (Do not use multiplexed molecular diagnostic)
4b. If your laboratory used a multiplexed diagnostic in 2024 and the result was suppressed, where does the
suppression occur?
□ C. difficile result is suppressed at the multiplexed molecular diagnostic instrument level (the result is not
entered into the laboratory information management system (LIMS))
□ C. difficile result is suppressed at the laboratory information management system (LIMS) level
□ C. difficile result is suppressed somewhere else
Specify: ______________
□ N/A (Do not use multiplexed molecular diagnostic or the result is never suppressed)

Multistep Algorithm Testing for CDI
5a. If your laboratory used a nucleic acid amplification test (NAAT) (e.g., Cepheid Xpert C. difficile) as first line
testing followed by a toxin EIA test (whenever NAAT result is positive) in 2024, did your laboratory suppress
the positive NAAT result so that clinicians could not see it?
□ Yes, NAAT result is always suppressed when NAAT result is positive and confirmatory toxin EIA result is
negative
□ Yes, NAAT result is always suppressed but laboratory will release the positive NAAT result upon clinician
request
□ Yes, NAAT result is suppressed in certain situations
Specify: ______________
□ No, clinicians always see the positive NAAT result
□ N/A (Do not use this type of multistep algorithm testing)
5b. If your laboratory used NAAT as first line testing followed by confirmatory toxin EIA testing in 2024, and
both the NAAT and toxin EIA results were released to the clinician, did your laboratory provide any comments
to help the clinician interpret the test results (e.g., NAAT-positive only result might represent colonization,
etc.)?
□ Yes, laboratory provides comments to accompany the test results
o If yes, please specify the comments your laboratory uses to accompany the test results:
_______________________
□ No, laboratory does not provide comments to accompany the test results
□ The laboratory provides comments to accompany the test results in certain situations

Form Approved
OMB No. XXX-XXXX

If yes, please specify the situations in which your laboratory provides comments and the
comments your laboratory uses to accompany the test results: _______________________
N/A (Do not use this type of multistep algorithm testing or NAAT test result is always suppressed)
o

□

Testing Codes
6. What are the LOINC or internal testing codes associated with the tests your lab used in 2024 (e.g. LOINC
codes 13957-6, 34713-8, or 54067-4)?
Specify: __________________________

Laboratory Policies
7. Did your lab have a policy to reject stool specimens for C. difficile testing in 2024? (Read all options. Check
all that apply, even if it only applies sometimes)
□ Yes, when stools are formed (formed stools are defined as stools that do NOT take the shape of the
container)
□ Yes, if there was a positive stool specimen recently (e.g. within 24 hours, within 7 days)
□ Yes, if there was a negative stool specimen recently (e.g. within 24 hours, within 7 days)
□ Yes, will not accept more than one stool specimen in a 24 hr period
□ Yes, if patient is on a specific medication (e.g. laxatives)
□ No rejection policy
□ Other rejection policies
Specify other rejection policy: __________________________
7a. Did your rejection policy for stool specimens change between January 1, 2024 and December 31, 2024?
⃝ Yes
What date did this change occur? ______ / ______ / ______
Specify changes: __________________________
⃝ No

Form Approved
OMB No. XXX-XXXX

Testing Capacity
8. How many stool samples did you test for C. difficile each month in 2024?
Month
Stool samples tested
C. diff+ samples
January
February
March
April
May
June
July
August
September
October
November
December

Form Approved
OMB No. XXX-XXXX

Appendix: Common C. difficile Test Kit Names and Manufactures
EIA Toxin A & B
Wampole* Toxin A/B Quik Chek
Techlab* C. difficile Toxin A/B II
BioMerieux Vidas C. difficile Toxin A/B
Meridian Immunocard Toxin A/B
Meridian Premier Toxin A/B
Remel Xpect C. difficile Toxin A/B
Remel ProSpecT Toxin A/B
EIA Antigen (GDH)
Wampole* C. difficile Chek-60
Wampole* C. difficile Quik Chek
Meridian Immunocard C. difficile
EIA Toxin A/B and Antigen (Simultaneous Testing)
Wampole* C. difficile Quik Chek Complete
Nucleic Acid Amplification
BD-GeneOhm C. difficile
Cepheid Xpert C. difficile
Great Basin Portrait Toxigenic C. difficile Assay
Luminex xTAG Gastrointestinal Pathogen Panel (xTAG GPP)
Meridian BioScience Illumigene
Nanosphere Verigene SP
Prodesse (Gen-Probe) Progastro CD
Quidel AmpliVue C. difficile Assay
EIA for Toxin B Only
Alere* C. difficile Toxin B

*Techlab, Inverness Medical, Alere, Wampole may be used interchangeably for these test kits