A23. Attachment 2_APPENDIX A_.pdf

APPENDIX A

Clinical Immunization Safety Assessment (CISA) Project Clinical Consultation Process

Clinical Immunization Safety Assessment (CISA) Project is a national collaborating network of vaccine safety experts from the CDC’s Immunization Safety Office (ISO), medical research centers, and other partners. CDC established the CISA Project to improve the understanding of adverse events following immunization at the individual patient level. Healthcare providers or health departments in the United States can request a consultation from CISA for a complex vaccine safety question that is (1) about an individual patient residing in the United States or vaccine safety issue and (2) not readily addressed by CDC or Advisory Committee on Immunization Practices (ACIP) guidelines. The main goal of the CISA consultation service is to assist healthcare providers with vaccination clinical decisions for their patients.

More information is available here. Clinical Immunization Safety Assessment (CISA) Project | CISA | Monitoring | Ensuring Safety | Vaccine Safety | CDC and provided below.

Fig 1- CISA Flow: Vaccine safety Clinical inquiry from healthcare providers or health department.

Two approaches will generally be used to address vaccine safety requests for a consult about a specific patient or vaccine safety clinical inquiries:

1. CISA structured clinical case consultation (Led by a CISA Site Contractor)

2. CISA enhanced inquiry response (Led by CDC)

Some consults may require more than one mechanism. For example, an enhanced inquiry response may need to be escalated to a full clinical case consultation if the provider writes back with more complex questions after receipt of the first email answering the inquiry. Regardless of the specific consultation type utilized, the following applies: advice from the CDC and CISA experts is meant to assist in clinical decision-making rather than to provide direct patient management. Patient management decisions are the responsibility of the treating healthcare provider.

NOTE: CISA consults are covered under a CDC Assurance of Confidentiality CDC - Assurances of Confidentiality - OSI - OS

1. CISA structured clinical case consultation A CISA investigator for clinical consultation will lead this effort, with technical input from CDC. CISA will use a structured process to prepare a case for review on a CISA Work Group call. Allowing for time needed to obtain complete medical records for review, the time from receipt of the initial consult request https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/cisa/index.html https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/cisa/index.html https://www.cdc.gov/os/integrity/confidentiality/index.htm https://www.cdc.gov/os/integrity/confidentiality/index.htm to scheduling the call can be up to three months; however, a shortened timeline may be used for urgent cases. See figures 2 and 3 for a description of a process.

2. CISA Enhanced Inquiry Response The enhanced inquiry response is a more streamlined and less in-depth approach to address vaccine safety questions that are less complex. It is also useful when the caller has a clinical question but is not directly taking care of a patient (such as a query from a health department) or when medical records are not needed or not available. For CISA enhanced inquiries, CDC leads the response and obtains expert input from CISA subject matter experts at the lead and contributing sites.

Figure 2: CISA Clinical Consultation structured process:

This process is a guide; not all consults include every step

Figure 3: CISA algorithm to assess causality after AEFI*

CISA algorithm to assess causality a�er AEFI*

Pathway continues

*Halsey NA, et al. Algorithm to Assess Causality a�er Individual Adverse Events Following Immuniza�ons. Vaccine. 2012 Apr 13