Burden memo - legionnaires AL

2014004-XXX Burden Memo.docx

Emergency Epidemic Investigation Data Collections - Expedited Reviews

Burden memo - legionnaires AL

OMB: 0920-1011

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CDC DOCUMENTATION FOR THE GENERIC CLEARANCE

OF EMERGENCY EPIDEMIC INVESTIGATION DATA COLLECTIONS (0920-1011)

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GenIC No.:

2014004-053

EPI AID No. (if applicable):

EPI-AID 2014-53

Requesting entity (e.g., jurisdiction)

ALABAMA DEPARTMENT OF PUBLIC HEALTH

Title of Investigation:

Undetermined risk factors and mode of transmission in a healthcare-associated Legionnaires’ disease outbreak—Alabama, 2014

Purpose of Investigation: (Use as much space as necessary)


The objectives of this investigation are to:

1. Conduct an epidemiologic investigation to determine possible exposures and identify additional cases of Legionnaires’ disease among patients at University of Alabama, Birmingham.

2. Complete an environmental assessment of Legionnaires’ disease risk and environmental sampling for Legionella at the hospital.

3. Recommend prevention and control measures to stop disease transmission and prevent additional morbidity and mortality.

Duration of Data Collection


Date Began:

May 24, 2014

Date Ended:

Ongoing

Lead Investigator


Name:

Louise Francois-Watkins

CIO/Division/Branch:

NCIRD/DBD/RDB/Epi

E-mail Address:

[email protected]

Telephone No.:

404-639-4755

Mail Stop:

C25



Complete the following for each instrument used during the investigation.


Data Collection Instrument 1


Name of Data Collection Instrument: Legionnaires Disease_Chart Abstraction Form


Type of Respondent

[ ] General Public

[ ] Healthcare staff

[ ] Laboratory staff

[X] Patients

[ ] Restaurant staff

[ ] Other: [describe]


Data Collection Methods (check all that apply)

[X ] Epidemiologic Study (indicate which type(s) below)

[X ] Descriptive Study (describe): Case finding and case confirmation: Known cases of Legionnaires’ disease will be reviewed and new cases of Legionnaires’ disease associated with exposure to the hospital will be identified by reviewing hospital patient records and health department surveillance systems, laboratory records, and patient medical charts for symptoms and test results characteristic of Legionnaires’ disease. A medical chart abstraction form will be used. Medical record abstraction completed by Alabama Department of Health staff and CDC.


[X] Cross-sectional Study (describe): Reviewed medical records

[ ] Cohort Study (describe):

[ ] Case-Control Study (describe):

[ ] Other (describe):

[ X ] Environmental Assessment (describe): An environmental assessment of the water system will be conducted, including additional environmental sampling of the water and swabs from the water fixtures.

4. Biospecimen samples: Urine samples from cases identified by the hospital might be collected and sent to CDC for confirmatory testing by urine Ag testing. Culture positive isolates from respiratory specimens may be sent to CDC for Sequence Based Typing which will help correlate with the environmental isolates. Biospecimen samples, if taken, might be collected by the Alabama Department of Health or Hospital A solely though CDC will assist if requested by the state to do so.

[X] Laboratory Testing (describe): Clinical respiratory specimens will undergo confirmation at CDC

[ ] Other (describe):


Data Collection Mode (check all that apply)

[ ] Survey Mode (indicate which mode(s) below):

[ ] Face-to-face Interview (describe):

[ ] Telephone Interview (describe):

[ ] Self-administered Paper-and-Pencil Questionnaire (describe):

[ ] Self-administered Internet Questionnaire (describe):

[ ] Other (describe):

[X] Medical Record Abstraction (describe): No personal information was collected. Information regarding demographics, clinical signs and symptoms, laboratory findings, treatment information was collected.

[ ] Biological Specimen Sample:

[X] Environmental Sample: Bulk water samples and swab from points-of-use were collected; total of 64 samples

[ ] Other (describe):


Response Rate (if applicable)

Total No. Responded (A):


Total No. Sampled/Eligible to Respond (B):


Response Rate (A/B):



(Additional Data Collection Instrument sections may be added if necessary.)



Complete the following burden table. Each data collection instrument should be included as a separate row.


Burden Table (insert rows for additional respondent types if needed)

Data Collection Instrument Name

Type of Respondent

No. Respondents (A)

No. Responses per Respondent (B)

Burden per Response in Minutes (C)

Total Burden

(in minutes;

A x B x C)

Legionnaires Disease_Chart Abstraction Form

Patient

9

1

90

810 minutes














Return completed form and a blank copy of each final data collection instrument within 5 business days of data collection completion to the EEI Information Collection Request Liaison, Danice Eaton ([email protected]).


EI Information Collection Request Liaison:

Danice Eaton, PhD, MPH

EIS Program Staff Epidemiologist

Epidemiology Workforce Branch

Division of Scientific Education and Professional Development

Centers for Disease Control and Prevention

2400 Century Center, MS E-92

Office: 404.498.6389
[email protected]



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