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nchsls:c:pathology:document:21

Procedure for management of reagents and consumables

Name Unique ID Edition/Date of Edition
Procedure for management of reagents and consumablesnchsls:c:pathology:document:2103-01-2015
Preparing authority Approving authority Review period
All teaching staff of Pathology Department HOD Pathology 1 year
Controlled copy of this document exists in electronic form at IP address 10.207.3.240 of LAN at NCH, Surat
Printed copy without signature of authorized person of this document is considered uncontrolled.

Processes requiring this procedure

Material resource management process

Subprocesses for management of reagents and consumables
Procurement
Use
Disposal

Procedure

Procedure for procurement

1.Perform following procedure within limits of Government of Gujarat rules and regulations

2.Parent institute is both New Civil Hospital Surat and Government Medical College Surat.

3.If completing an examination procedure require a consumable prepare its specifications and other conditions required from suppliers, in consultation with the parent institute.

4.Communicate the requirement with specification to the parent institute.

5.The parent institute selects a list of suppliers from which the department can choose one or more supplier

  • select and approve suppliers based on their ability to supply external services, consumable, reagents and consumable supplies in accordance with the laboratory’s requirements. This process is called Technical Scrutiny
  • The list of selected and approved suppliers of consumable is maintained at office of the parent institute.

6.Ask parent institute to procure the consumable from finalized supplier(s).

7.Communicate the laboratory management regarding adequacy of supply and maintenance by the supplier from time to time, e.g when inadequacy is found or during MRM.

8.When the consumable arrives in the laboratory verify that consumable specifications and other conditions required from suppliers are acceptable.

  1. For kits
    1. check temperature of container in which kit is supplied. It should be as prescribed in manufacturer's instructions.
    2. check expiry date of each kit, it should be longer than period stated in original specifications required.
    3. check its bottle volume and total volume.
    4. check other specifications, if required.
    5. If any thing of above is not acceptable , return it to the transporter or to central store with appropriate note.
    6. Record the kit observations in Inventory records.
    7. Record the receipt of consumables in appropriate registers and indent books, as required by rules and regulations of parent institute.
    8. Give laboratory id to each kit box (for first in first out mode of use)
  1. For dry and liquid chemicals and other consumables

    1. check specifications, pack size, manufacturer brand other specifications.
    2. If any thing of above is not acceptable , return it to the transporter or to central store with appropriate note.
    3. Record the receipt of consumables in appropriate registers and indent books, as required by rules and regulations of parent institute. Include manufacturer name and lot numbers in registers.
      • Store all consumables as per manufacturer's instructions. For any deficit in space, refrigerators, freezers, put the issue before management committee.

9.Use it for performing examinations for which it is required, using quality control materials, to find weather the performance of consumable is appropriate to the need or not.

10.In the event above conditions are not met, do not use consumable for examinations of patient samples. Follow rules and regulations of the parent institute to return consumable to the supplier.

11.If any adverse incidents and accidents occur that can be attributed directly to specific consumable, follow Procedure for identification, control, correction and prevention of nonconformities and report to the manufacturer and appropriate authorities.

Consumable Records Location
identity of the reagent or consumable File/Records/16/Master record of reagents
manufacturer’s name and batch code or lot number File/Records/16/Master record of reagents
contact information for the supplier or the manufacturerIn central store
date of receiving, the expiry date, date of entering into service File/Records/16/Master record of reagents
condition when received File/Records/16/Master record of reagents
records that confirmed the reagent’s or consumable’s initial acceptance for use File/Records/16/Acceptance records (Lot validation)
performance records that confirm the reagent’s or consumable’s ongoing acceptance for use
User instruction and safety records File/Records/16/User instruction & safety records (MSDS)
Any adverse incident File/Records/16/Adverse incident reports
nchsls/c/pathology/document/21.txt · Last modified: 2022/08/13 07:34 (external edit)