Justification for Change and Table of Changes

Active Bacterial Core Surveillance (ABCs)

Background

The National Center for Immunization and Respiratory Diseases (NCIRD) of the Centers for Disease Control and Prevention (CDC) is requesting approval of changes to four data collection forms that have previously been approved under OMB no. 0920-0978; expiration date 8/31/2016. These forms are used to conduct surveillance to determine the incidence and epidemiologic characteristics of invasive disease due to Haemophilus influenzae, Neisseria meningitidis, group A Streptococcus, group B Streptococcus, Streptococcus pneumoniae, methicillin-resistant Staphylococcus aureus, and Legionella spp..

The forms for which approval for changes are being sought include:

1. 2013 ABCs Case Report Form—(Attachment 2)

2. 2013 ABCs Invasive Methicillin-resistant Staphylococcus aureus Case Report Form—(Attachment 3)

3. 2013 ABCs Neonatal Infection Expanded Tracking Form—(Attachment 4)

4. 2013 ABCs Legionellosis Case Report Form—(Attachment 5)

Description of Changes

Minor changes are being requested for the 2013 ABCs Case Report Form, the 2013 ABCs Invasive Methicillin-resistant Staphylococcus aureus Case Report Form, the 2013 Neonatal Infection Expanded Tracking Form and the 2013 ABCs Legionellosis Case Report Form in order to streamline and enhance disease surveillance for the pathogens under surveillance. The changes from the previously approved forms are minimal and will not result in a change to previously estimated burden hours, as per communication with surveillance officers (form respondents).

Detailed Description of Changes

1. 2013 ABCs Case Report Form changes include:

1. The order of the questions have been reordered to improve logic flow and prioritize key variables

2. Questions 33-35. The time frame has changed from 7-days prior to the first positive culture date to 14-days prior to the first positive culture date.

3. Addition to questions 35. A date field was added to assess when an invasive group A Streptococcus case had prior skin trauma or injury. See below.

If YES to any of the above, record the number of days prior to the first positive culture (if > 1 day, use most recent skin injury).

1  0-7 days

2  8-14 days

4. Additional underlying conditions have been added along with updates to current conditions on the CRF. The underlying conditions ‘Alcohol abuse’ and ‘IVDU’ (intravenous drug user) were used from 1998-2012. Two additional checkboxes, to record both current and past use, were added for alcohol abuse and IVDU. Two other checkboxes were added for ‘Other drug use’ (i.e. one for current and one for past use. See below.

CRF variable description	Variable coding
Alcohol abuse, current	Numeric: 1=Yes, 0=No
Alcohol abuse, past	Numeric: 1=Yes, 0=No
IVDU, current	Numeric: 1=Yes, 0=No
IVDU, past	Numeric: 1=Yes, 0=No
Other drug use, current	Numeric: 1=Yes, 0=No
Other drug use, past	Numeric: 1=Yes, 0=No

2. 2013 ABCs Invasive Methicillin-resistant Staphylococcus aureus Case Report Form changes include:

   1. In order to clarify variable capture, question 5 has been changed to “Where was the patient located on the 4^th calendar day prior to culture?”

   2. To be consistent with instructions question 9 was changed to “Was patient hospitalized at the time of, or within 30 calendar days after initial culture?”

   3. To improve clarity, question 14 was changed to “Were cultures of the same or other sterile site(s) positive within 30 days after initial culture date?”

   4. Slight modification of option for ‘Abscess/Boil’ in underlying conditions to “Abscess/Boil (Recurrent) in question 16.

3. 2013 ABCs Neonatal Infection Expanded Tracking Form changes include:

1. Question 9a. The word ‘any’ has been bolded and italicized.

2. Question 9b has collapsed with the following question, 9c, and will now read:

9b. IF YES, were any of the following ICD-9 codes reported in the discharge diagnosis of the chart? (check all that apply)

 041.02: Streptococcus, group b

 038.0: Streptococcus septicemia

 041.1: Streptococcus, unspecified

 320.2: Streptococcal meningitis

4. 2013 ABCs Legionellosis Case Report Form changes include:

   1. Additional underlying conditions have been added along with updates to current conditions on the CRF. The underlying conditions ‘Alcohol abuse’ and ‘IVDU’ (intravenous drug user) were used from 2011-2012. Two additional checkboxes, to record both current and past use, were added for alcohol abuse and IVDU. Two other checkboxes were added for ‘Other drug use’ (i.e. one for current and one for past use. See below.

CRF variable description	Variable coding
Alcohol abuse, current	Numeric: 1=Yes, 0=No
Alcohol abuse, past	Numeric: 1=Yes, 0=No
IVDU, current	Numeric: 1=Yes, 0=No
IVDU, past	Numeric: 1=Yes, 0=No
Other drug use, current	Numeric: 1=Yes, 0=No
Other drug use, past	Numeric: 1=Yes, 0=No

2. For questions 25, 27, 28 and 29, the ‘Other’ (specify) checkbox option was changed to L. species, other (specify) for clarity.

Cross walk of 2013 form changes

1. 2013 ABCs Case Report Form

Question on 2012 form	Question on 2013 form
Group A Streptococcus (#31-33 refer to the 7 days prior to the first positive culture)	Group A Streptococcus (#33-35 refer to the 14 days prior to the first positive culture)
33. Did patient have: 1 □ Varicella 1 □ Penetrating trauma 1 □ Blunt trauma 1 □ Surgical wound (post-operative) 1 □ Burns	35. Did patient have: 1 □ Varicella 1 □ Penetrating trauma 1 □ Blunt trauma 1 □ Surgical wound (post-operative) 1 □ Burns If YES to any of the above, record the number of days prior to the first positive culture (if >1, use the most recent skin injury) 1 □ 0-7 days 1 □ 8-14 days
24. Underlying conditions 1 □ Alcohol Abuse 1 □ IVDU	27. Underlying conditions 1 □ Alcohol Abuse, Current 1 □ Alcohol Abuse, Past 1 □ IVDU, Current 1 □ IVDU, Past 1 □ Other Drug Use, Current 1 □ Other Drug Use, Past

2. 2013 ABCs Invasive Methicillin-resistant Staphylococcus aureus Case Report Form

Question on 2012 form	Question on 2013 form
5. Where was a patient a resident prior to the date of initial culture? (See CRF Instructions)	5. Where was the patient located on the 4th calendar day prior to the date of initial culture?
9. Was patient hospitalized within 30 calendar days after initial culture?	9. Was the patient hospitalized, at the time of, or in the 30 calendar days, after initial culture?
14. Were cultures of the SAME or OTHER sterile site(s) positive within 30 days after initial culture?	14. Were cultures of the SAME or OTHER sterile site(s) positive within 30 days after initial culture date?
16. Underlying conditions 1 □ Abscess/Boil	16. Underlying conditions 1 □ Abscess/Boil (Recurrent)

3. 2013 ABCs Neonatal Infection Expanded Tracking Form

Question on 2012 form	Question on 2013 form
9a. Were any ICD-9 codes reported in the discharge diagnosis of the infant’s chart?	9a. Were any ICD-9 codes reported in the discharge diagnosis of the infant’s chart?
9b. IF YES, was the ICD-9 code “041.02” reported in the discharge diagnosis of the infant’s chart? 9c. IF YES, were any of the following ICD-9 codes reported in the discharge diagnosis of the chart (check all that apply) □ 038.0: Streptococcus septicemia □ 041.0 Streptococcus, unspecified □ 320.2: Streptococcal meningitis	9b. IF YES, were any of the following ICD-9 codes reported in the discharge diagnosis of the chart? (Check all that apply) □ 041.02: Streptococcus group b □ 041.0: Streptococcus, unspecified □ 038.0: Streptococcus septicemia □ 320.2: Streptococcal meningitis

4. 2013 ABCs Legionellosis Case Report Form

Question on 2012 form	Question on 2013 form
23. Underlying conditions 1 □ Alcohol Abuse 1 □ IVDU	23. Underlying conditions 1 □ Alcohol Abuse, Current 1 □ Alcohol Abuse, Past 1 □ IVDU, Current 1 □ IVDU, Past 1 □ Other Drug Use, Current 1 □ Other Drug Use, Past
25 Culture, species 1 □ .L. pneumophila If yes, list serogroup: 1 □ serogroup 1 8 □ Other (specify) ________ 9 □ Unknown 2 □ L. species (non-pneumophila) 8 □ Other (specify) ______ 9. □ L. species, unknown or not specified	25 Culture, species 1 □ .L. pneumophila If yes, list serogroup: 1 □ serogroup 1 8 □ Other (specify) ________ 9 □ Unknown 2 □ L. species (non-pneumophila) 8 □ L. species, other (specify) ______ 9. □ L. species, unknown or not specified
27 PCR, species 1 □ .L. pneumophila If yes, list serogroup: 1 □ serogroup 1 8 □ Other (specify) ________ 9 □ Unknown 2 □ L. species (non-pneumophila) 8 □ Other (specify) ______ 9. □ L. species, unknown or not specified	27 PCR, species 1 □ .L. pneumophila If yes, list serogroup: 1 □ serogroup 1 8 □ Other (specify) ________ 9 □ Unknown 2 □ L. species (non-pneumophila) 8 □ L. species, other (specify) ______ 9. □ L. species, unknown or not specified
28 DFA (direct fluorescence assay, direct specimen only), species 1 □ .L. pneumophila If yes, list serogroup: 1 □ serogroup 1 8 □ Other (specify) ________ 9 □ Unknown 2 □ L. species (non-pneumophila) 8 □ Other (specify) ______ 9. □ L. species, unknown or not specified	28 DFA (direct fluorescence assay, direct specimen only), species 1 □ .L. pneumophila If yes, list serogroup: 1 □ serogroup 1 8 □ Other (specify) ________ 9 □ Unknown 2 □ L. species (non-pneumophila) 8 □ L. species, other (specify) ______ 9. □ L. species, unknown or not specified
29 IHC (immunohistochemistry), species 1 □ .L. pneumophila If yes, list serogroup: 1 □ serogroup 1 8 □ Other (specify) ________ 9 □ Unknown 2 □ L. species (non-pneumophila) 8 □ Other (specify) ______ 9. □ L. species, unknown or not specified	29 IHC (immunohistochemistry), species 1 □ .L. pneumophila If yes, list serogroup: 1 □ serogroup 1 8 □ Other (specify) ________ 9 □ Unknown 2 □ L. species (non-pneumophila) 8 □ L. species, other (specify) ______ 9. □ L. species, unknown or not specified