0929-1011 GenIC Request Memo

File Name: 2023001-XXX VIM-CRPA_multistate

Request for Approval Under the Generic Clearance for

Emergency Epidemic Investigation Data Collections
(0920-1011)

Instruction: This form should be completed by the primary contact person from the CDC CIO that will be sponsoring the investigation.

Determine if your investigation is appropriate for this Generic mechanism: Instruction: Before completing and submitting this form, determine first if the proposed investigation is appropriate for the EEI Generic ICR mechanism. Complete the checklist below. If you select “yes” to all criteria in Column A, the EEI Generic IR mechanism can be used. If you select “yes” to any criterion in Column B, the EEI Generic ICR mechanism cannot be used.

Column A	Column B
CDC epidemiological assistance is requested by one or more external partners (e.g., local, state, tribal, military, port, other federal agency, or international health authority or other partner organization). Yes No	The Investigation is initiated by CDC, without request from an external partner. Yes No
The investigation is urgent in nature (i.e., timely data are needed to inform rapid public health action to prevent or reduce injury, disease, or death). Yes No	The investigation is not urgent in nature. Yes No
The investigation is characterized by undetermined agent, undetermined source, undetermined mode of transmission, or undetermined risk factors. Yes No	The investigation is conducted for the primary purpose of program evaluation, surveillance, needs assessment, or research to contribute to generalizable knowledge. Yes No
One or more CDC staff (including trainees and fellows) will be deployed to the field. Yes No	CDC staff (including trainees or fellows) are not deployed to the field. Yes No
Data collection will be completed in 90 days or less. Yes No	Data collection expected to require greater than 90 days. Yes No

Did you select “Yes” to all criteria in Column A?

If yes, the EEI Generic ICR may be appropriate for your investigation. → You may proceed with this form.

Did you select “Yes” to any criterion in Column B?

If yes, the EEI Generic ICR is not appropriate for your investigation. → Stop completing this form now.

GenIC #

2023001

-

XXX

Date

12/15/2022

Title of Investigation: Instruction: Provide the title of the investigation in the following format: [Undetermined agent, undetermined source, undetermined mode of transmission, undetermined risk factor] for [disease/problem] among [subpopulation]—[State], [Year]

Investigation of a multistate cluster of VIM-producing carbapenem resistant Pseudomonas aeruginosa

Location of Investigation: Instruction: Indicate location where investigation will occur. If multiple locations, specify each one.

State:	Multistate
City/County (if applicable)
Country	USA

Requesting Agency: Instruction: Indicate name of agency requesting epidemiological assistance and the name and position title of the requestor

Agency:	Council for State and Territorial Epidemiologist
Name and Position Title:	Janet Hamilton; Director of the Council for State and Territorial Epidemiologists

Note: Attach the Letter of Invitation requesting support. The letter should include the following information: 1) background on the outbreak or event; 2) steps already taken toward prevention and control, if any; 3) request for CDC assistance, including objectives of the investigation; and 4) how data will be used to inform prevention and control measures. Sensitive information in the Letter of Invitation not appropriate for public dissemination should be redacted.

Description of Investigation

1. Problem to be Investigated: Instruction: Provide a summary of the outbreak or event. The summary should include all the information you know at this time about the outbreak or event and the investigation that is planned. At a minimum, please provide the following information: 1) background necessary to understand the importance of the outbreak or event, including a justification of the need for an investigation and why this issue requires an urgent response; 2) the objectives of the investigation, including how the information collected will be used to inform prevention and control measures; and 3) a brief overview of the investigation planned, including study design, respondents, mode of data collection. In the description, indicate whether a data collection instrument is attached with the GenIC request (refer to as Appendix 1, etc) and what instruments will be developed in the field. (suggested length: 250-500 words).

Outbreak Summary: In collaboration with state health departments, DHQP is investigating a multistate cluster of VIM-producing carbapenem-resistant Pseudomonas aeruginosa (VIM-CRPA) possibly linked to a contaminated product. From May 1, 2022-December 15, 2022, 48 confirmed isolates from 41 patients in 10 different states (California, Colorado, Connecticut, Florida, Nevada, New Mexico, New York, Texas, Utah, Washington; additional states may be added to the investigation if new cases are identified in their jurisdiction) have been identified. Among these, 31 patients are part of 4 facility clusters (1 eye clinic, 3 long-term acute care hospitals [LTACHs]) and there are no known epidemiological links between patients from different states. All isolates were ST1203 with VIM-80 and GES-9 carbapenemase genes (a combination not previously seen in the U.S.), and closely related based on whole genome sequencing (WGS) analysis. We are concerned these cases might be linked to a contaminated product.

Objectives: The objectives of this investigation are to: 1) identify new cases associated with this cluster, 2) describe the epidemiology of the cases, 3) identify potential outbreak sources, and 3) identify and implement prevention and control measures to prevent new infections.

Investigation Methods: CDC will share a template excel file (Appendix 2) for collecting product information with Healthcare Associated Infection and Antimicrobial Resistance (HAI/AR) programs at Public Health Departments and ask them to contact facilities (for facility clusters or admitted patients) in order to assess which medical products are used. Once completed product lists are received, CDC will analyze to identify common products used by facilities to generate a hypothesis of potential outbreak sources. CDC will also share with all HAI/AR programs reporting cases a chart abstraction form (Appendix 1) to assess case-patient past-medical history, travel history, recent healthcare exposures including inpatient admissions; outpatient visits; invasive devices; and surgeries, and medications and products received. Medical products identified as potential outbreak sources will be collected to facilitate culturing by CDC and/or FDA and submitted by health departments with a standard submission form (OMB Control No.: 0920-1309, Expiration Date 11/30/2023). Ongoing case finding and whole genome sequencing (WGS) for VIM-CRPA will be conducted in accordance with existing procedures of the Antimicrobial Laboratory network (ARLN) (OMB Control No.: 0920-1310; Expiration Date 12/31/2023). It is an existing practice for these laboratories to perform WGS on VIM-CRPA isolates and upload data to NCBI or share with CDC, and this will not initiate new data collection. If new cases are detected HAI/AR programs will be asked to review facility products and complete the medical record chart abstraction form. This EEI requests OMB approval for the chart abstraction form (Appendix 1) and the product list form (Appendix 2).

2. Characteristics of Outbreak or Event (Check all that Apply):

Undetermined agent

Undetermined source

Undetermined mode of transmission

Undetermined risk factor

3. Respondents: Instruction: Select all that apply. For each respondent type selected, provide a brief description. Be sure to include a description of control respondents, if applicable. Use as much space as necessary for each description.

General public (describe):

HAI/AR program staff at Public Health Departments in jurisdictions where case-patients are identified (appendices 1-2).

Healthcare staff (describe):

Laboratory staff (describe):

Patients (describe):

Restaurant staff (describe):

Other (describe):

4. Selection of Respondents: Instruction: Provide a brief description of how respondents will be identified and selected. Use as much space as necessary for the description.

Each jurisdiction will identify an HAI/AR program staff person to complete the data collection forms (appendices 1-2).

5. Study Design: Instruction: Select all that apply. For each study design planned, provide a brief description. Use as much space as necessary for the description.

Epidemiologic Study (indicate which type(s) below)

Descriptive Study (describe):

Will describe the underlying epidemiology of case patients and potential sources of the outbreak (appendices 1-2).

Cross-sectional Study (describe):

Cohort Study (describe):

Case-Control Study (describe):

Other (describe):

Environmental Assessment (describe):

Laboratory Testing (describe):

Other (describe):

6. Data Collection Mode: Instruction: Select all that apply. For each data collection mode planned, provide a brief description. Use as much space as necessary for the description.

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):

Medical Record Abstraction (describe):

Chart abstraction will be conducted by Public Health Departments with CDC’s assistance using a standardized abstraction form which will be entered into Redcap (Appendix 1)

Biological Specimen Sample

Environmental Sample:

Other (describe):

Facility product lists will be obtained by Public Health departments and shared with CDC. Sampling of medical products implicated in the outbreak will be conducted at CDC or FDA (Appendix 2).

7. Type of Information to be Collected: Instruction: Select all that apply. For each type of information to be collected, provide a brief description. Use as much space as necessary for the description.

Behaviors (describe):

Clinical information/symptoms (describe):

Past medical history, travel history, recent healthcare exposures, invasive devices, medications, medical product received, invasive procedures and surgeries, etc. (Appendices 1-2)

Contact information (describe):

Demographic information (describe):

Age, sex, race/ethnicity (Appendix 1)

Environmental factors (describe):

Exposures (describe):

Travel history, recent healthcare exposures, invasive devices, medications, medical product received, invasive procedures and surgeries, etc. (Appendices 1-2)

Medical history (describe):

Past medical history, recent healthcare exposures, invasive devices, medications, medical product received, invasive procedures and surgeries, etc. (Appendices 1-2)

Risk factors (describe):

Past medical history, travel history, recent healthcare exposures, invasive devices, medications, medical product received, invasive procedures and surgeries, etc. (Appendices 1-2)

Specimen/lab information (describe):

Travel history (describe):

History of international travel or healthcare and history of healthcare outside of state of residence (Appendix 1)

Other (describe):

8. Duration of Data Collection (number of weeks):

12

Research Determination: Instruction: Indicate the research determination decision. If the decision is research, provide the research determination letter and IRB approval, if required.

Research

Not Research

CDC Investigation Lead: Instruction: Indicate the name, title, and affiliation of the person who will serve as the CDC lead for this investigation.

Name:	Marissa Grossman
Title:	EIS Officer
Affiliation:	CDC’s Division of Healthcare Quality Promotion

CDC Sponsoring Program and Primary Contact Person: Instruction: Indicate the sponsoring CIO/Division/Branch for this investigation. Indicate the name, title, and contact information of the CDC Primary Contact Person for this investigation. Indicate the preferred method of contact during the OMB approval process. Note, contact person or a designee must be available during the OMB approval process in case questions arise.

CIO/Division/Branch:	NCEZID/DHQP/PRB
Name:	Marissa Grossman
Title:	EIS Officer

Certification: Please read the certification carefully. Type your name to validate that you are providing certification. Note: If you incorrectly certify, the collection will be returned as improperly submitted or it will be disapproved. Certification should be signed by the CDC Primary Contact Person for this Investigation.

I, [insert name of CDC sponsoring program contact], certify the following to be true:

1. The collection is voluntary.

2. Respondents will not be personally identified in any published reports of the study.

3. Information gathered will be primarily used to inform effective prevention and control measures.

CDC Sponsoring Program Primary Contact Name:	Marissa Grossman
Date of Certification:	12/16/2022

Requested Approval Date (mm/dd/yyyy): Instruction: Indicate the date by which approval is needed.

12/27/2022

E-mail the completed form to the Information Collection Request Liaison (ICRL) or EIS program ICRL designee.

Date Form Revised: GenIC 6.16.14 4