According to CDC record-keeping guidelines issued under the National Childhood Vaccine Injury Act, which specific piece of information must be documented in the patient's chart every time a vaccine is administered to ensure legal accountability for the product used?
Time of the patient's post-injection observation period
Federal law (42 U.S.C. §300aa-25) and CDC best-practice guidance require that each vaccination entry include the vaccine's manufacturer and lot number, the administration date, the VIS edition/date provided, and the name-title-address of the person administering the dose. The lot number uniquely identifies the exact batch and is critical for product recalls or adverse-event investigations. Expiration date and observation time may be useful for inventory or clinical monitoring, but they are not mandated by the Act. The ordering provider's name is also not required unless that person actually administered the vaccine.
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