14 About the Mother-Infant Identification Package

Definition 14.1 (Live Birth Delivery) Live births are defined using a code list developed by the Medication Exposure in Pregnancy Risk Evaluation Program (MEPREP) and other Sentinel and non Sentinel pregnancy-related projects.1–3 Identification of live births based on the original work in MEPREP has been updated to incorporate ICD-10-CM and ICD-10 Procedure Coding System (ICD-10-PCS) codes. Live birth deliveries, as identified in the description above, are eligible for the MIL table when they have the following additional characteristics: the encounter occurred at least one year later than the start of Data Partner data availability, the woman was between 10 and 54 years of age as of the admission date of the delivery encounter, there is no evidence of delivery for 180 days prior, and the woman had 180 days of continuous medical coverage, gaps of up to 45 days allowed, through the delivery date. Infant records with the following characteristics are eligible for the MIL table: date of birth identified at least one year later than the start of Data Partner data availability, and at least one day of enrollment with medical coverage during first year of life.

References

1.
Alison Tse Kawai, Grace M. Lee, Azadeh Shoaibi. Mini-Sentinel CBER/PRISM Surveillance Protocol Influenza Vaccines and Pregnancy Outcome. Version 2.; 2014. https://www.sentinelinitiative.org/studies/vaccines-blood-biologics/influenza-vaccines-and-pregnancy-outcomes-prism
3.
Li Q, Andrade SE, Cooper WO, et al. Validation of an algorithm to estimate gestational age in electronic health plan databases: VALIDITY OF GESTATIONAL AGE ALGORITHM. Pharmacoepidem Dr S. 2013;22(5):524-532. doi:10.1002/pds.3407

Disclosure

The Sentinel System is sponsored by the U.S. Food and Drug Administration (FDA) to proactively monitor the safety of FDA-regulated medical products and complements other existing FDA safety surveillance capabilities. The Sentinel System is one piece of FDA's Sentinel Initiative, a long-term, multi-faceted effort to develop a national electronic system. Sentinel Collaborators include Data and Academic Partners that provide access to healthcare data and ongoing scientific, technical, methodological, and organizational expertise. The Sentinel Operations Center is funded by the FDA through the Department of Health and Human Services (HHS) Task order 75F40119D10037.