Are in-house made QC materials accepted by ISO 15189?
The major reason for most lab test not being on QC program is the availability or high of commercially prepared QC materials. Do you use in-house prepared QC materials for some tests in your lab? if so it is acceptable by ISO 15189?
Comments
We use in house prepared QC materials for hematology test (CBC) in the absence of manufacture QC materials for the analyzer . It is verified and accept ed by accreditation organization , but not to be used routinenly , it mainly check the precition not the accuracy . Better to work to get the manufacture provided QC materials or certified reference materials to ensure our testing quality fulfilled .
We use in house controls but these controls are validated with the commercial QC materials or certified reference materials
Yes inhouse are accepted as long as they satisfy requirement for inhouse prepared reagents such as date prepared , who prepared , concentration prepared if applicable, expiry date if and SOP for maintenance of the Inhouse prepared QC materials
iSO 15189:2022 , Clause 6.6.7
"Where the laboratory uses reagents prepared, resuspended or combined in-house, the records shall include, in addition to the relevant information above, reference to the person or persons undertaking the preparation, as well as the dates of preparation and expiry."
kindly explain the preparation or protocol for inhouse CBC controls
Dear Isack , we customized from this source page 15 , there is also CLSI guide for in-house control use but to be purchased online .
In-House QC are accepted as long as they are "FIT-FOR-PURPOSE"
Kennedy can you please share your SOP for this process? Thanks
Thanks Award