Reagents that require refrigeration or freezing are stored in reagent fridges / freezers that are temperature controlled. This is monitored by the REES temperature monitoring system. Each department has a documented procedure relating to equipment failure that provides a designated back-up fridge / freezer in the event of failure. 5.3.2.3 Reagents & consumables- Acceptance Testing Each new batch of examination kits with changes in reagent, procedure, lot number or consignment, has its performance verified before use. This is performed according to the documented procedure on batch acceptance in each department. Any consumables that affect the quality of examinations shall also be verified before use. 5.3.2.4 Reagents & consumables- Inventory Management Each department has an inventory control system for reagents & consumables. This system segregates uninspected and unacceptable reagents. 5.3.2.5 Reagents & consumables- Instructions for use Current instructions and instructions for use, of reagents & consumables are manufacturer’s available on Q-Pulse. External documents are recorded and given a document number. Where they are available as an electronic file they are attached in Q-Pulse, or else stored as a hard copy in the relevant department. 5.3.2.6 Reagents & consumables-Adverse Incident reporting Adverse incidents & accidents associated directly with specific reagents & consumables should be recorded and processed as per incident reporting procedures outlined in Serious adverse incidents associated with specific reagents & consumables are reported to the Health Products Regulatory Authority 5.3.2.7 Reagents & consumables- Records The following records are maintained for each reagent & consumable that is used for testing purposes. Figure : Reagents & Consumables-Records Record ID Record Description Record Location Identity of the reagent or Batch acceptance log in individual department. consumable name, batch or Manufacturer’s Batch acceptance log in individual department. lot number Contact information for the supplier or manufacturer. Supplier module of Q-pulse Date of receipt, expiry date, date of entering into service, & Batch acceptance log in individual department date material was taken out of service where applicable. Conditions when received Acceptance log in individual department
Reagents that require refrigeration or freezing are stored in reagent fridges / freezers that are temperature controlled. This is monitored by the REES temperature monitoring system. Each department has a documented procedure relating to equipment failure that provides a designated back-up fridge / freezer in the event of failure. 5.3.2.3 Reagents & consumables- Acceptance Testing Each new batch of examination kits with changes in reagent, procedure, lot number or consignment, has its performance verified before use. This is performed according to the documented procedure on batch acceptance in each department. Any consumables that affect the quality of examinations shall also be verified before use. 5.3.2.4 Reagents & consumables- Inventory Management Each department has an inventory control system for reagents & consumables. This system segregates uninspected and unacceptable reagents. 5.3.2.5 Reagents & consumables- Instructions for use Current manufacturer’s instructions and instructions for use, of reagents & consumables are available on Q-Pulse. External documents are recorded and given a document number. Where they are available as an electronic file they are attached in Q-Pulse, or else stored as a hard copy in the relevant department. 5.3.2.6 Reagents & consumables-Adverse Incident reporting Adverse incidents & accidents associated directly with specific reagents & consumables should be recorded and processed as per incident reporting procedures outlined in Serious adverse incidents associated with specific reagents & consumables are reported to the Health Products Regulatory Authority 5.3.2.7 Reagents & consumables- Records The following records are maintained for each reagent & consumable that is used for testing purposes. Figure : Reagents & Consumables-Records Record ID Record Description Record Location Identity of the reagent or consumable Batch acceptance log in individual department. Manufacturer’s name, batch or lot number Batch acceptance log in individual department. Contact information for the supplier or manufacturer. Supplier module of Q-pulse Date of receipt, expiry date, date of entering into service, & date material was taken out of service where applicable. Batch acceptance log in individual department Conditions when received Acceptance log in individual department