Vaccine Cold Chain Responsibility
Vaccine quality is the shared responsibility of all parties from the time the vaccine is manufactured until administration, meaning that once vaccines arrive at a location, the receiving health facilities—not the manufacturer—assume responsibility for maintaining the cold chain. 1
Understanding Cold Chain Responsibility Transfer
The statement that "maintenance of the cold chain remains the responsibility of the manufacturer" after arrival is incorrect. Here's the accurate framework:
Shared Responsibility Model
Vaccine quality represents a shared responsibility across the entire supply chain, extending from manufacturing through final administration to the patient. 1
Upon receipt at health facilities, the responsibility for cold chain maintenance transfers from the manufacturer/shipper to the receiving institution. 1
All vaccines must be inspected and monitored immediately upon arrival to ensure the cold chain was maintained during shipment, and then stored at recommended temperatures without delay. 1
Critical Operational Requirements at Receiving Facilities
Once vaccines arrive at health facilities, the following responsibilities fall to the receiving institution:
Designated personnel with written duties must be trained in vaccine storage and handling, with backup personnel also identified and trained. 1
Temperature monitoring must occur at minimum twice daily with accurate, calibrated thermometers placed properly in all vaccine storage units. 1
Temperature logs must be reviewed for completeness, with any deviations from recommended ranges prompting immediate corrective action and documentation. 1
Vaccines exposed to out-of-range temperatures must be marked "do not use" and physically isolated while contacting state/local health departments or manufacturers for guidance. 1
Common Pitfall: Assuming Manufacturer Responsibility Continues
Mishandled vaccines may appear identical to potent vaccines, making it impossible to visually distinguish compromised products—this underscores why proper storage protocols at receiving facilities are critical. 1, 2
When doubt exists about appropriate vaccine handling, the receiving facility should contact the manufacturer for guidance, but this consultation does not transfer responsibility back to the manufacturer. 1
The 24-Hour Customs Clearance Statement
The requirement for customs clearance within 24 hours of arrival is a logistical consideration for international shipments, but does not alter the fundamental principle that cold chain responsibility transfers to the receiving party upon delivery. 1