Lot verification practices in Ontario clinical chemistry laboratories - Results of a patterns-of-practice survey

Angela C Rutledge; Anna Johnston; Ronald A Booth; Kika Veljkovic; Dana Bailey; Hilde Vandenberghe; Gayle Waite; Lynn C Allen; Andrew Don-Wauchope; Pak Cheung Chan; Julia Stemp; Pamela Edmond; Victor Leung; Berna Aslan

doi:10.1016/j.plabm.2022.e00300

Lot verification practices in Ontario clinical chemistry laboratories - Results of a patterns-of-practice survey

Pract Lab Med. 2022 Aug 10:32:e00300. doi: 10.1016/j.plabm.2022.e00300. eCollection 2022 Nov.

Authors

Angela C Rutledge^{1

2}, Anna Johnston^{1

3}, Ronald A Booth^{1

4}, Kika Veljkovic^{1

5}, Dana Bailey^{1

6}, Hilde Vandenberghe^{7

8}, Gayle Waite^{6

7}, Lynn C Allen^{7

9}, Andrew Don-Wauchope^{1

5}, Pak Cheung Chan^{1

10}, Julia Stemp^{3

7}, Pamela Edmond^{1

2}, Victor Leung^{1

11}, Berna Aslan^{3

12}

Affiliations

¹ Institute for Quality Management in Healthcare (IQMH) Endocrinology and Immunology Scientific Committee, Toronto, Ontario, Canada.
² Department of Pathology and Laboratory Medicine, London Health Sciences Centre and St. Joseph's Health Care London, London, Ontario, Canada.
³ IQMH, Toronto, Ontario, Canada.
⁴ Division of Biochemistry, The Ottawa Hospital and Department of Pathology and Laboratory Medicine, University of Ottawa, Ottawa, Ontario, Canada.
⁵ LifeLabs, Toronto, Ontario, Canada.
⁶ Dynacare Medical Laboratories, Brampton, Ontario, Canada.
⁷ IQMH Chemistry Scientific Committee, Toronto, Ontario, Canada.
⁸ Mount Sinai Hospital, Toronto, Ontario, Canada.
⁹ Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario, Canada.
¹⁰ Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.
¹¹ Department of Laboratory Medicine, Joseph Brant Hospital, Burlington, Ontario, Canada.
¹² Division of Laboratory Medicine, Eastern Health and Faculty of Medicine, Memorial University of Newfoundland, St. John's, Newfoundland and Labrador, Canada.

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.

Keywords: CLSI, Clinical and Laboratory Standards Institute; Calibrator; ELISA, enzyme-linked immunosorbent assay; GC, gas chromatography; HPLC, high-performance liquid chromatography; IQMH, Institute for Quality Management in Healthcare; ISO, International Organization for Standardization; LC-MS/MS, liquid chromatography tandem mass spectrometry; Lot number; PT, proficiency testing; QC, quality control; RIA, radioimmunoassay; Reagent; TSH, thyroid-stimulating hormone; Verification.