Emergency SSB Tijana CRPA

Verona Integron-Encoded Metallo-β-Lactamase (VIM)-Producing Carbapenem-Resistant Pseudomonas aeruginosa Infections Associated with Invasive Medical Procedures in Tijuana, Mexico

Request for OMB approval of a New Information Collection

March 14, 2019

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 individuals who had surgery since January 1, 2019 at Facility 1 in Tijuana, Mexico and are at highest risk for developing VIM-CRPA infection and/or receiving ongoing treatment for surgical site infection in the U.S. healthcare system.   An additional 550 U.S. residents who had surgery at Facility 1 in Tijuana, Mexico between August 1 and December 31, 2018 are at lower risk for developing new VIM-CRPA infection but may be surveyed if interviews of more recent exposed individuals suggest high rates of infection and hospitalization that could facilitate spread of this multidrug-resistant organism in the U.S. healthcare system. No additional individuals will be included in the activity.

2. Procedures for the Collection of Information

Information on individuals who underwent surgery at Facility 1 will be collected by telephone interview. CDC will ask state and local health departments to contact individuals who underwent surgery at Facility 1 after January 1, 2019 by telephone to notify them of the potential risk of bacterial and BBP infection and to use a standardized survey instrument to assess exposures (e.g., type of surgery), infections post-surgery, hospital re-admissions post-surgery, and receipt of prior public health messaging (Appendix I). CDC will perform notifications and conduct surveys for jurisdictions that request assistance.

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

Response to the survey is voluntary. Given the severity of the events, CDC will work with state and local health departments to achieve the highest response rate possible. We expect to have 80% response rate from individuals. The information requested has been limited to the absolute minimum required for the public health investigation in order to minimize the public burden.

4. Tests of Procedures or Methods to be undertaken

We piloted the survey internally for readability and flow and to assess the time required to complete the survey. 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 DGMQ and multiple state health departments.

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

Individuals collecting and analyzing data are public health professionals based at state and local health departments and CDC and are experienced in administering public health surveys. Individuals in performing analysis are expert in the primarily descriptive statistics that will be performed. As no high-level statistical methods are used in this data collection or analysis, no statisticians were consulted.