1. The personnel responsible for consumables should regularly inventory all consumables in the laboratory, submit timely procurement requests, and conduct inspections upon receiving consumables.

2. Laboratory testing personnel must strictly adhere to operating procedures, conduct quality checks on received reagent kits, and assess the specificity, sensitivity, compliance rate, and detection limit of the kits for pathogenic nucleic acid detection.

Laboratory Consumables Procurement Workflow

Consumables

1. Strictly follow relevant regulations; consumables should have three complete certificates (production license, product registration certificate, business license).

The laboratory head, based on the work needs of the department, recent consumption of consumables, and stock levels, should create a monthly procurement plan. This plan, along with the previous month's consumption and inventory, is submitted with a purchase requisition. The department head reviews and signs the requisition. The procurement is managed and executed by the institutional purchasing and management team.

2. Inspection of Received Goods

   • Outer Packaging Inspection: Ensure the packaging is intact, clean, and well-labeled with manufacturer details, product name, approval number, production date, expiration date, etc.

   • Inner Packaging Inspection: Check for damage, leaks, completeness of contents, and the presence of corresponding user manuals.

   • Record the above checks upon receipt and categorize items in the reagent storage area.

3. Quality Inspection Procedures

   • Centrifuge Tubes Inspection:

     • Visual Inspection: Check for deformities, damages, and lids that cannot be closed.
     • Experimental Inspection: If any issues are found during visual inspection or after repeated occurrences of bursting or leakage, conduct experimental testing.
     • Testing Procedure:
       • Randomly select 30 centrifuge tubes for experimental testing.
       • Centrifuge the selected tubes at 10,000 rpm for 20 minutes with half the physiological saline volume.
       • If lid bursting or leakage occurs, consider the batch unacceptable and process it for return.
       • Conduct additional tests for potential contamination and oil ester pollution.
     • Activation: If no issues are found, activate the batch of centrifuge tubes for use.

   • Pipette Tips Inspection:

     • Visual Inspection: Check for deformities and damages.
     • Experimental Inspection: Randomly select 30 pipette tips for experimental testing. Use a suitable sampler to aspirate ink-containing glycerol, checking for filter core leakage. Aspirate a suitable liquid volume to check for clogging and air leakage. If abnormalities are found, consider the batch unacceptable and process it for return.
     • Activation: If no issues are found, activate the batch of pipette tips for use.

4. All personnel must observe the appearance and characteristics of consumables when using or distributing them.

5. If any quality issues with consumables arise, promptly report them in writing to the laboratory head. With the approval of the department head, notify the hospital procurement center to handle the return or exchange procedures.

6. Storage of Consumables:

   • Consumables pre-sterilization should be placed in the reagent reserve area. After processing based on daily workload, they can be stored in the reagent preparation area, sample preparation area, and amplification and product analysis area.
   • Commonly used consumables should be placed in laboratory drawer storage based on daily workload. Special consumables should be stored in designated areas.
   • Keep records of usage and promptly replenish quantities used.
   • Handle glassware with care to avoid damage.
   • Before ordering consumables, accurately verify the quantities.