{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["32"],"submitter":["Rutledge AC"],"pubmed_abstract":["

Objectives

Verifying new reagent or calibrator lots is crucial for maintaining consistent test performance. The Institute for Quality Management in Healthcare (IQMH) conducted a patterns-of-practice survey and follow-up case study to collect information on lot verification practices in Ontario.

Methods

The survey had 17 multiple-choice questions and was distributed to 183 licensed laboratories. Participants provided information on materials used and approval/rejection criteria for their lot verification procedures for eight classes of testing systems. The case study provided a set of lot comparison data and was distributed to 132 laboratories. Responses were reviewed by IQMH scientific committees.

Results

Of the 175 laboratories that responded regarding reagent lot verifications, 74% verified all tests, 11% some, and 15% none. Of the 171 laboratories that responded regarding calibrator lot verifications, 39% verified all calibrators, 4% some, and 57% none. Reasons for not performing verifications ranged from difficulty performing parallel testing to high reagent cost. For automated chemistry assays and immunoassays, 23% of laboratories did not include patient-derived materials in reagent lot verifications and 42% included five to six patient materials; 58% of laboratories did not include patient-derived materials in calibrator lot verifications and 23% included five to six patient materials. Different combinations of test-specific rules were used for acceptance criteria. For a failed lot, 98% of laboratories would investigate further and take corrective actions. Forty-three percent of laboratories would accept the new reagent lot in the case study.

Conclusion

Responses to the survey and case study demonstrated variability in lot verification practices among laboratories."],"journal":["Practical laboratory medicine"],"pagination":["e00300"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC9399155"],"repository":["biostudies-literature"],"pubmed_title":["Lot verification practices in Ontario clinical chemistry laboratories - Results of a patterns-of-practice survey."],"pmcid":["PMC9399155"],"pubmed_authors":["Bailey D","Chan PC","Booth RA","Vandenberghe H","Stemp J","Rutledge AC","Johnston A","Waite G","Veljkovic K","Allen LC","Edmond P","Aslan B","Leung V","Don-Wauchope A"],"additional_accession":[]},"is_claimable":false,"name":"Lot verification practices in Ontario clinical chemistry laboratories - Results of a patterns-of-practice survey.","description":"

Objectives

Verifying new reagent or calibrator lots is crucial for maintaining consistent test performance. The Institute for Quality Management in Healthcare (IQMH) conducted a patterns-of-practice survey and follow-up case study to collect information on lot verification practices in Ontario.

Methods

The survey had 17 multiple-choice questions and was distributed to 183 licensed laboratories. Participants provided information on materials used and approval/rejection criteria for their lot verification procedures for eight classes of testing systems. The case study provided a set of lot comparison data and was distributed to 132 laboratories. Responses were reviewed by IQMH scientific committees.

Results

Of the 175 laboratories that responded regarding reagent lot verifications, 74% verified all tests, 11% some, and 15% none. Of the 171 laboratories that responded regarding calibrator lot verifications, 39% verified all calibrators, 4% some, and 57% none. Reasons for not performing verifications ranged from difficulty performing parallel testing to high reagent cost. For automated chemistry assays and immunoassays, 23% of laboratories did not include patient-derived materials in reagent lot verifications and 42% included five to six patient materials; 58% of laboratories did not include patient-derived materials in calibrator lot verifications and 23% included five to six patient materials. Different combinations of test-specific rules were used for acceptance criteria. For a failed lot, 98% of laboratories would investigate further and take corrective actions. Forty-three percent of laboratories would accept the new reagent lot in the case study.

Conclusion

Responses to the survey and case study demonstrated variability in lot verification practices among laboratories.","dates":{"release":"2022-01-01T00:00:00Z","publication":"2022 Nov","modification":"2025-06-01T02:00:34.744Z","creation":"2025-06-01T02:00:34.744Z"},"accession":"S-EPMC9399155","cross_references":{"pubmed":["36035320"],"doi":["10.1016/j.plabm.2022.e00300"]}}