Form 0920-0978 Annual Survey of Laboratory Testing Practices for C. dif

Form Approved
OMB No. 092-0978
Expires: xx/xx/xxxx

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: _____ /_____ /_____
Is this a new laboratory?
⃝ Yes
⃝ No
Year added to surveillance: ___________
Is this lab in another EIP site?
⃝ Yes
What state? ____________________
LabID in other EIP site: ____________________
⃝ No
Is this lab participating in surveillance?
⃝ Yes
⃝ No
How often do you receive line lists from this lab?
⃝ Daily
⃝ Weekly
⃝ Monthly
⃝ Annually
⃝ Never
⃝ Other
Specify: __________________________
Public reporting burden of this collection of information is estimated to average 15 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).

How do you receive line lists from this lab?
⃝ Electronic laboratory reporting (e.g. HL7 messaging)
⃝ Fax
⃝ Email
⃝ Mail
⃝ Secure file transfer
⃝ Other
Specify: __________________________
Do you receive specimens from this lab?
⃝ Yes
⃝ No
Was this lab audited in 2019?
⃝ 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 (select all that apply):
⃝ Hospitals
⃝ LTACHs
⃝ LTCFs
⃝ Outpatient facilities

Section 2: Survey
To be completed by lab personnel
Position of the staff who responded to the survey:
⃝ Laboratory Supervisor
⃝ Microbiology Supervisor
⃝ Other
Specify: ____________________

Offsite Testing
1. Does your laboratory ever send specimens off-site for Clostridioides difficile testing? (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: __________________________

Testing Routine for CDI
2. What type and order of testing is routinely used by your laboratory in standard testing for C. difficile?
(Enter letter from choices below; choose only one option for each line of testing)
1st line of testing: ________ 2nd line of testing: ________ 3rd line of testing: ________
A. EIA Toxin A and B
B. EIA for Toxin A only
C. EIA for Toxin B only
D. EIA Antigen (GDH)
E. EIA Toxin A/B and Antigen (Simultaneous testing)
F. EIA Other
Specify other EIA type: __________________________
G. Nucleic Acid Amplification (e.g. PCR, Illumigene, Luminex, Biofire)
H. Culture
I. Cytotoxin
J. Other
Specify other test type: __________________________
K. No one routine test; clients can order from among several tests
Specify types: __________________________
L. None
2a. Which specimens are used during your 2nd line of testing? (Choose one)
⃝ Positive by the 1st line of testing
⃝ Negative by the 1st line of testing
⃝ Specimens with discordant results (e.g. EIA+/GDH- or GDH+/EIA-)
⃝ All specimens
⃝ Do not use 2nd line of testing
2b. Which specimens are used during your 3rd line of testing? (Choose one)
⃝ Positive by the 2nd line of testing
⃝ Negative by the 2nd line of testing
⃝ Specimens with discordant results (e.g. EIA+/GDH- or GDH+/EIA-)
⃝ All specimens
⃝ Do not use 3rd line of testing

2c. Does your laboratory perform any onsite testing for C. difficile outside of your normal testing algorithm?
⃝ No, all onsite testing is done according to the testing algorithm specified above
⃝ Yes, on physician request
Specify tests: __________________________
⃝ Other
Specify: __________________________

Testing Kits for CDI
3a. Which EIA test kit is currently used by your laboratory? (Check all that apply)
□ 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 is currently used by your laboratory? (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)

Multiplex GI panels
4a. If your laboratory uses a multiplexed molecular diagnostic (e.g., Biofire Filmarray GI Panel, Luminex xTAG
GPP) to test for several GI pathogens, does your laboratory suppress the C. diff result so that clinicians cannot
see it?
□ Yes, always
□ Yes, at clinician request
□ Yes, but will release the result upon clinician request
□ Yes, sometimes
Specify: ______________
□ No, clinicians always see C. diff result
□ N/A (Do not use multiplexed molecular diagnostic)
4b. If your laboratory uses a multiplexed diagnostic and the result is suppressed, where does the suppression
occur?
□ At the multiplexed molecular diagnostic instrument level (the result is not entered into the laboratory
information management system (LIMS))
□ At the laboratory information management system (LIMS) level
□ Other

Specify: ______________
□

N/A (Do not use multiplexed molecular diagnostic or the result is never suppressed)

Testing Codes
5. What are the testing codes associated with the tests your lab currently uses?
Specify: __________________________

Laboratory Algorithm Changes
6. Has your lab testing algorithm for C. difficile changed since January 1, 2019?
⃝ Yes
What date did this change occur? ______ / ______ / ______
⃝ No
6a. (If yes) What was your previous type and order of testing?
(Enter letter from choices below; choose only one option for each line of testing)
1st line of testing: ________ 2nd line of testing: ________ 3rd line of testing: ________
A. EIA Toxin A and B
B. EIA for Toxin A only
C. EIA for Toxin B only
D. EIA Antigen (GDH)
E. EIA Toxin A/B and Antigen (Simultaneous testing)
F. EIA Other
Specify other EIA type: __________________________
G. Nucleic Acid Amplification (e.g. PCR, Illumigene, Luminex, Biofire)
H. Culture
I. Cytotoxin
J. Other
Specify other test type: __________________________
K. No one routine test; clients can order from among several tests
Specify types: __________________________
L. None
6b. Which specimens were used during your 2nd line of testing? (Choose one)
⃝ Positive by the 1st line of testing
⃝ Negative by the 1st line of testing
⃝ Specimens with discordant results (e.g. EIA +/GDH- or GDH+/EIA-)
⃝ All specimens
⃝ Do not use 2nd line of testing (go to question 6)
6c. Which specimens were used during your 3rd line of testing? (Choose one)
⃝ Positive by the 2nd line of testing
⃝ Negative by the 2nd line of testing
⃝ Specimens with discordant results (e.g. EIA+/GDH- or GDH+/EIA-)
⃝ All specimens
⃝ Do not use 3rd line of testing (go to question 6)

Laboratory Policies
7. Does your lab have a policy to reject stool specimens for C. difficile testing? (Read all options. Check all that
apply)
□ Yes, when stools are formed (formed stools are defined as stools that do NOT take the shape of the
container)
□ Yes, if there is a stool specimen already positive within 24 hrs of a new stool specimen
□ Yes, if there is a stool specimen already positive within 48 hrs of a new stool specimen
□ Yes, if there is a stool specimen that tested negative for C. difficile within 48 hours of a new stool
specimen
□ Yes, will not accept more than one stool specimen in a 24 hr period
□ No rejection policy
□ Other rejection policies
Specify other rejection policy: __________________________
7a. Has your rejection policy for stool specimens changed since January 1, 2019?
⃝ Yes
What date did this change occur? ______ / ______ / ______
Specify changes: __________________________
⃝ No

Testing Capacity
8. How many stool samples did you test for C. diff each month in 2019?
Month
Stool samples tested
C. diff+ samples
January
February
March
April
May
June
July
August
September
October
November
December

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