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Lithium is the first-line treatment for maintenance therapy in bipolar disorder. It is an effective mood stabilizer agent, and may have potential benefits in neuroprotection and reducing the risk of suicide. Toxicity has been a concern in recent decades, particularly in older adults (≥60 years). In 2019, the Older Adults Task Force within the International Society for Bipolar Disorder (ISBD) published recommendations for age-stratified lithium therapeutic ranges for therapy of Older Age Bipolar Disorder (OABD), namely 0.4 - 0.8 mmol/L for ages 60 to 79 and 0.4 - 0.7 mmol/L for ages 80 and above. Clinical laboratory practice surveys in Canada indicated that adoption and implementation of the proposed ranges has been limited to date. In this article, we describe the approach and steps taken to evaluate and implement recommended lithium therapeutic ranges in Ontario and other provinces in Canada for laboratory quality improvement. Sources of variation in lithium reporting practices are discussed and shared here to highlight potential barriers to implementation. The overall goal of this article is to bring attention across the global laboratory community that lower lithium therapeutic target ranges in older patients are crucial for patient safety in OABD.
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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.
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OBJECTIVES: Method imprecision, error rates, and explanatory causes that were identified in the Institute for Quality Management in Healthcare point-of-care (POC) glucose proficiency testing (PT) program were assessed in comparison with results obtained from laboratory glucose PT surveys. METHODS: POC and laboratory glucose PT data were assessed from September 2009 to June 2011. Peer group means and coefficients of variation (CVs) were estimated using the robust algorithm recommended in the International Organization for Standardization/International Electrotechnical Commission 13528(E). Discordant finding investigations were also reviewed to determine the causes of significant and recurring errors. RESULTS: POC glucose CVs were higher than laboratory method CVs (median CV, 4.5% and 1.6%, respectively). While all laboratory glucose results were within the performance limits, 305 (0.59%) of 51,379 POC glucose results exceeded limits. Investigations were required for 277 (0.53%) POC results. Pre- and postanalytical errors accounted for 76% of the discordant findings. Using wrong PT items, sample mix-up on the bench, and reporting results for the wrong sample were the most frequent reasons, while 21% of discordant findings identified manufacturer issues, and 3% were of unknown origin. CONCLUSIONS: Both method CVs and error rates were higher in POC than in laboratory glucose methods, even though larger performance limits were used for the assessment of POC glucose.