Crosswalk of HAIC changes (Jan 2021)

Cross walk - 2021 form changes

HAIC

1. MuGSI Case Report Form for Carbapenem-resistant Enterobacteriaceae (CRE) and Acinetobacter baumannii (CRAB)

Note: Changes for the updated 2021 CRF are highlighted in yellow.

Question on original 2021 form

Question on revised 2021 form

26a. Was the incident specimen tested for carbapenemase?

 Yes

 No

 Laboratory not testing

 Unknown

26a. Was the incident specimen tested for carbapenemase genes?

 Yes

 No

 Laboratory not testing

 Unknown

26b. If yes, what testing method was used (check all that apply)

Non-Molecular Tests:

 CarbaNP

 Carbapenemase Inactivation Method (CIM)

 Disk Diffusion/ROSCO Disk

 E-test

 Modified Carbapenemase Inactivation Method (mCIM)

 Modified Hodge Test (MHT)

 RAPIDEC

 Other (specify):_______________

 Unknown

Molecular Tests:

 Automated Molecular Assay

 Carba-R

 Check Points

 MALDI-TOF MS

 Next Generation Nucleic Acid Sequencing

 PCR

 Streck ARM-D

 Other (specify):________________

 Unknown

26b. If yes, what testing method was used (check all that apply)

Non-Molecular Test Methods:

 CarbaNP

 Carbapenemase Inactivation Method (CIM)

 Disk Diffusion/ROSCO Disk

 E-test

 Modified Carbapenemase Inactivation Method (mCIM)

 Modified Hodge Test (MHT)

 RAPIDEC

 Other (specify):_______________

 Unknown

Molecular Test Methods:

 Automated Molecular Assay

 Carba-R

 Check Points

 MALDI-TOF MS

 Next Generation Nucleic Acid Sequencing

 PCR

 Streck ARM-D

 Other (specify):________________

 Unknown

26c. If tested, what was the testing result?

Non-Molecular Test Results:

□ Positive

□ Negative

□ Indeterminate

□ Unknown

Molecular Test Results:

□ NDM	□ Pos	□ Neg	□ Ind	□ Unk
□ KPC	□ Pos	□ Neg	□ Ind	□ Unk
□ OXA	□ Pos	□ Neg	□ Ind	□ Unk
□ OXA-48	□ Pos	□ Neg	□ Ind	□ Unk
□ VIM	□ Pos	□ Neg	□ Ind	□ Unk
□ IMP	□ Pos	□ Neg	□ Ind	□ Unk
□ Other Specify:______________	□ Pos	□ Neg	□ Ind	□ Unk

26c. If tested, what was the testing result?

Non-Molecular Test Results:

□ Positive

□ Negative

□ Indeterminate

□ Unknown

Molecular Test Results:

□ NDM	□ Pos	□ Neg	□ Ind	□ Unk
□ KPC	□ Pos	□ Neg	□ Ind	□ Unk
□ OXA (specify):______	□ Pos	□ Neg	□ Ind	□ Unk
□ VIM	□ Pos	□ Neg	□ Ind	□ Unk
□ IMP	□ Pos	□ Neg	□ Ind	□ Unk
□ Other carbapenemase gene (specify):____________	□ Pos	□ Neg	□ Ind	□ Unk

27a. Was the incident specimen tested for ESBL production or other beta-lactamase genes?

 Yes

 No

 Laboratory not testing

 Unknown

27b. If tested, what testing method was used? (Check all that apply)

 Broth microdilution (ATI detection)

 ESBL well

 Expert rule (ATI flag)

 Unknown

 Broth Microdilution (Manual)

 Disk Diffusion

 E-test

 Molecular test (specify)

 Gene variant (specify)

 Other non-molecular test (specify)

27c. If tested, what was the result?

 Positive

 Negative

 Indeterminate

 Unknown

27. Susceptibility results

Antibiotic

Amikacin

Amoxicillin/Clavulanate

Ampicillin

Ampicillin/Sulbactam

Aztreonam

Cefazolin

Cefepime

Cefiderocol

Cefotaxime

Cefoxitin

Ceftazidime

Ceftazidime/Avibactam

Ceftolozane/Tazobactam

Ceftriaxone

Cephalothin

Ciprofloxacin

Colistin

Doripenem

Doxycycline

Eravacycline

Ertapenem

Fosfomycin

Gentamicin

Imipenem

Imipenem-relebactam

Levofloxacin

Meropenem

Meropenem-vaborbactam

Minocycline

Nitrofurantoin

Omadacycline

Piperacillin/Tazobactam

Plazomicin

Polymyxin B

Rifampin

Tetracycline

Tigecycline

Tobramycin

Trimethoprim-sulfamethoxazole

Data source

Medical record

Microscan

Vitek

Phoenix

Sensititre

Kirby-Bauer

E-test

28. Susceptibility results

Antibiotic

Amikacin

Amoxicillin/Clavulanate

Ampicillin

Ampicillin/Sulbactam

Aztreonam

Cefazolin

Cefepime

Cefiderocol

Cefotaxime

Cefoxitin

Ceftazidime

Ceftazidime/Avibactam

Ceftolozane/Tazobactam

Ceftriaxone

Cephalothin

Ciprofloxacin

Colistin

Doripenem

Doxycycline

Eravacycline

Ertapenem

Fosfomycin

Gentamicin

Imipenem

Imipenem-relebactam

Levofloxacin

Meropenem

Meropenem-vaborbactam

Minocycline

Nitrofurantoin

Omadacycline

Piperacillin/Tazobactam

Plazomicin

Polymyxin B

Rifampin

Tetracycline

Tigecycline

Tobramycin

Trimethoprim-sulfamethoxazole

Data source

Medical record

Microscan

Vitek

Phoenix

Sensititre

Kirby-Bauer

E-test

28a. Was case first identified through audit?

 Yes

 No

29a. Was the case first identified through an audit?

 Yes

 No

28b. CRF status

 Complete

 Pending

 Chart unavailable after 3 requests

29b. CRF status

 Complete

 Pending

 Chart unavailable after 3 requests

28c. SO initials

_______________

29c. SO initials

_______________

28d. Date of abstraction

__-__-____

29d. Date of abstraction

__-__-____

28e. Comments

_______________

29e. Comments

_______________

2. Multi-site Gram-Negative Surveillance Initiative (MuGSI)- Extended-Spectrum Beta-Lactamase-Producing Enterobacteriaceae (ESBL)

Note: Changes for the updated 2021 ESBL CRF are highlighted in yellow.

Question on original 2021 form	Question on revised 2021 form
	26b. Was the incident specimen tested for ESBL production or other beta-lactamase genes?  Yes  No  Laboratory not testing  Unknown
26b. What screening/confirmatory method was used for ESBL identification? (Check all that apply)  None  Unknown  Broth microdilution (ATI detection)  ESBL well  Expert rule (ATI flag)  Unknown  Broth Microdilution (Manual)  Disk Diffusion  E-test  Molecular test (specify)  Other non-molecular test (specify)	26c. If tested, what testing method was used? (Check all that apply)  Broth microdilution (ATI detection)  ESBL well  Expert rule (ATI flag)  Unknown  Broth Microdilution (Manual)  Disk Diffusion  E-test  Molecular test (specify)  Gene variant (specify)  Other non-molecular test (specify)
26c. If screening/confirmatory method was used, what was the result?  Positive  Negative  Indeterminate  Unknown	26c. If tested, what was the result?  Positive  Negative  Indeterminate  Unknown

3. Annual Survey of Laboratory Testing Practices for C. difficile Infections

Current	Proposed
Is this a new laboratory?	Was this a new laboratory in 2020?
Is this lab participating in surveillance?	Did this lab participate in surveillance in 2020?
How often do you receive line lists from this lab? Daily Weekly Monthly Annually Never Other	How often did you receive line lists from this lab in 2020? Whenever there is a positive case Daily Weekly Monthly Annually Never Other
How do you receive line lists from this lab?	How did you receive line lists from this lab in 2020?
Do you receive specimens from this lab?	Did you receive specimens from this lab in 2020?
Types of facilities in your catchment area served by this lab (select all that apply):	Types of facilities in your catchment area served by this lab in 2020 (select all that apply):
1. Does your laboratory ever send specimens off-site for Clostridioides difficile testing?	Did your laboratory ever send specimens off-site for Clostridioides difficile testing in 2020?
2. What type and order of testing is routinely used by your laboratory in standard testing for C. difficile?	2. What type and order of testing was routinely used by your laboratory in standard testing for C. difficile on December 31, 2020?
2a. Which specimens are used during your 2nd line of testing?	2a. Which specimens were used during your 2nd line of testing?
2b. Which specimens are used during your 3rd line of testing?	2b. Which specimens were used during your 3rd line of testing?
2c. Does your laboratory perform any onsite testing for C. difficile outside of your normal testing algorithm?	2c. Did your laboratory perform any onsite testing for C. difficile outside of your normal testing algorithm in 2020?
3a. Which EIA test kit is currently used by your laboratory?	3a. Which EIA test kit was used by your laboratory in 2020?
3b. Which Nucleic Acid Amplification test is currently used by your laboratory?	3b. Which Nucleic Acid Amplification test was used by your laboratory in 2020?
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)	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 2020, 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 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)	4b. If your laboratory used a multiplexed diagnostic in 2020 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)
[question did not exist]	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 2020, 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)
[question did not exist]	5b. If your laboratory used NAAT as first line testing followed by confirmatory toxin EIA testing in 2020, 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 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 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)
5. What are the LOINC or internal testing codes associated with the tests your lab currently uses (e.g. LOINC codes 13957-6, 34713-8, or 54067-4)?	6. What are the LOINC or internal testing codes associated with the tests your lab used in 2020 (e.g. LOINC codes 13957-6, 34713-8, or 54067-4)?
[question did not exist]	7a. In 2020, did your laboratory experience any shortages in supplies, reagents, and/or test kits for performing C. difficile testing (e.g., NAAT or EIA reagents, swabs)? Yes If yes, please specify the dates during which the supply shortage occurred (provide approximate dates if the exact dates are not known): __________ No N/A (C. difficile testing was not routinely performed on onsite)
[question did not exist]	7b. If your laboratory experienced a supply shortage for C. difficile testing in 2020, how did the shortage affect your laboratory’s ability to perform C. difficile testing? (Check all that apply) We had to decrease the frequency of C. difficile testing during the shortage We had to switch to an alternative method to test for C. difficile during the shortage We were not able to perform any type of C. difficile testing during the shortage We had to send all C. difficile testing offsite to another laboratory The shortage did not affect our ability to perform C. difficile testing Other, specify: _______________________________________ N/A (C. difficile testing was not routinely performed onsite)
[question did not exist]	7c. In 2020, did your laboratory experience a high demand for COVID-19 testing that limited the availability of staff (e.g., reduced staffing or work time) or the use of equipment to perform C. difficile testing? Yes No N/A (C. difficile testing and/or COVID-19 testing was not routinely performed onsite)
6. Has your lab testing algorithm for C. difficile changed since January 1, 2020?	8. Did your lab testing algorithm for C. difficile change between January 1, 2020 and December 31, 2020?
6a. (If yes) What was your previous type and order of testing?	8a. (If yes) What was the previous type and order of testing performed by your lab in 2020 before it changed its testing algorithm?
6b. Which specimens were used during your 2nd line of testing?	8b. Which specimens were used during your 2nd line of testing?
6c. Which specimens were used during your 3rd line of testing?	8c. Which specimens were used during your 3rd line of testing?
7. Does your lab have a policy to reject stool specimens for C. difficile testing?	9. Did your lab have a policy to reject stool specimens for C. difficile testing in 2020?
7a. Has your rejection policy for stool specimens changed since January 1, 2020?	9a. Did your rejection policy for stool specimens change between January 1, 2020 and December 31, 2020?
8. How many stool samples did you test for C. diff each month in 2020?	10. How many stool samples did you test for C. difficile each month in 2020?