Emergency SSB Serratia BSI Multiple States

Undetermined cause of Serratia marcescens infections — Multiple States, 2018

Request for OMB approval of a New Information Collection

April 26, 2018

Supporting Statement B

Contact:

Lee Samuel

National Center for Emerging and Zoonotic Infectious Diseases

Centers for Disease Control and Prevention

1600 Clifton Road, NE

Atlanta, Georgia 30333

Phone: (404) 718-1616

Email: [email protected]

Table of Contents

1. Respondent Universe and Sampling Methods 2

2. Procedures for the Collection of Information 2

3. Methods to maximize Response Rates and Deal with No Response 2

4. Tests of Procedures or Methods to be Undertaken 2

5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data 2

1. Respondent Universe and Sampling Methods

Respondents include healthcare workers including nurses, infection preventionists, and other staff from public health departments in the United States. Nationwide case-finding will be implemented (through Epi-X or professional email list). Any additional cases identified through case-finding will be included in the activity.

2. Procedures for the Collection of Information

Hospital staff and health department staff will review medical charts of case patients who suffered Serratia marcencens infections and abstract data onto a standardized report form. For any additional cases identified through case-finding, information of those cases provided by healthcare workers who report them will be collected onto a data collection form. Depending on the nature of each case, CDC may reach out to relevant healthcare facilities or healthcare staff for additional information (using chart abstraction form).

3. Methods to maximize Response Rates and Deal with No Response

CDC used a case definition of multiple patients in a single healthcare facility or cases among outpatients (i.e., patients who had not received care at an inpatient facility before illness onset) to decrease the number of case reports generated and limit reports to those patients likely to be related to the investigation. We expect to abstract all charts of case-patients. Healthcare facility and health department response to the data request is voluntary. Given the severity of the events, CDC will work with state and local health departments and healthcare staff to achieve the highest response rate possible. We expect to have 80% response rate from health department staff, with prioritization of data regarding patients whose test results indicate a strong connection (by molecular typing) to the outbreak investigation. The information requested has been kept to the absolute minimum in order to minimize the public burden.

4. Tests of Procedures or Methods to be undertaken

We did not perform a test of the abstraction forms or interview questions. The Division of Healthcare Quality Promotion has extensive experience carrying out investigations of this type (i.e., investigations of healthcare-associated infections or healthcare-related adverse events in dialysis facilities). We are actively collaborating with the Food and Drug Administration and multiple state health departments.

5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data

No statistical methods are used in this data collection. Therefore, no individuals were consulted.