Scientific Workshops will be held on Sunday, June 2:
Sunday June 5 Morning Part 1 – 0800-0930
- W050800-A Don’t Take That If You Need an Accurate Result: Impact of Supplements, Drugs, and Clinical Treatments on Clinical Chemistry Assays
- W050800-B Evidence-based Approach from the Canadian Society for Clinical Chemists (CSCC) Working Group on Reference Interval Harmonization (hRI)
Sunday June 5 Morning Part 2 – 0945-1115
- W050945-A Optimal Therapeutic Ranges of Serum Lithium Levels in Older Adults
- W050945-B One Clinical and Laboratory Information System: The Blood, Sweat and Cheers Towards Laboratory Standardization
Sunday June 5 Afternoon – 1300-1615
- W051300-A Actionable Insights Arising from an Algorithmic Big Data Analysis of Sequential Intrapatient Laboratory Results
- W051300-B Quality Assurance in Clinical Mass Spectrometry – Tools and Metrics to Address Challenges with Sample Preparation, Ion Suppression, Ongoing Validations and Result Analysis
W050800-A Don’t Take That If You Need an Accurate Result: Impact of Supplements, Drugs, and Clinical Treatments on Clinical Chemistry Assays
Sunday June 5, 0800-0930
Jessica Gifford, Alberta Precision Laboratories
Hossein Sadrzadeh, Alberta Precision Laboratories
Learning Objectives:
At the end of the session, the participants will be able to:
- Describe the mechanism of action of biotin, vitamin C, and a number of pharmaceuticals on blood and urine clinical chemistry tests.
- Describe the prevalence of this problem.
- Describe approaches to mitigate the problem posed by these pre-analytical assay interferences.
The impact of pre-analytical factors on laboratory test results has been discussed in the field of clinical chemistry for years. Despite this, the recent emergence of the interference of high-dose biotin supplements on clinical immunoassays demonstrates that this old issue has continued relevance. In this workshop we will discuss the impact of supplements and drugs on clinical chemistry assays. We will review the current literature summarizing the effects of biotin on immunoassays, discuss the prevalence of the issue both at the population level as well as identify affected instrumentation, discuss efforts by the clinical chemistry community to bring awareness of this issue, and explore strategies to help mitigate the risk. Like biotin, the interference of vitamin C on clinical chemistry assays is not a new issue with the manufacturers aware of the problem and occasionally taking mitigating steps in their reagent formulation. But again, like biotin the patient practice of taking vitamin C can pose a pre-analytical interference even when not taken in high-doses (ie. hospital nutrition vs. intravenous IV). Here we present cases of vitamin C interference on serum and urine test results, data on the prevalence of this issue in our laboratories, as well as demonstrate an in-house developed strategy to identify and mitigate the problem. Finally, we will discuss cases highlighting the effects of prescription drugs on urine immunoturbidometric tests. This workshop is aimed at clinical biochemists, general pathologists, clinical biochemistry fellows, general pathology residents, and medical laboratory technologists.
W050800-B Evidence-based Approach from the Canadian Society for Clinical Chemists (CSCC) Working Group on Reference Interval Harmonization (hRI)
Sunday June 5, 0800-0930
Khosrow Adeli, The Hospital for Sick Children
Dana Bailey, Dynacare
Mary Kathryn Bohn, The Hospital for Sick Children
Christine Collier, Royal Columbian Hospital
Learning Objectives:
At the end of the session, the participants will be able to:
- Outline the major gaps in reference intervals and the critical need for harmonization across clinical laboratories.
- Describe the major advances made by the CSCC Working Group on Reference Interval Harmonization.
- Discuss the development and validation of common reference intervals and their implementation across Canada.
Harmonization in laboratory medicine from specimen collection to result reporting is critical to ensure consistent and accurate clinical decision-making. Harmonized or common RIs refer to using one interpretative recommendation for an analyte across several laboratories, regardless of analytical assay or patient population. Harmonized or common RIs should therefore only be considered for assays that demonstrate minimal bias across considered methodologies. Several national surveys have reported wide variation in reference intervals across healthcare centres in certain regions, even those using the same analytical platform for test measurement. There is a high risk of inappropriate test result interpretation when reference intervals are not appropriately harmonized. The Canadian Society for Clinical Chemistry (CSCC) Working Group on Reference Interval Harmonization was established in 2015 to develop evidence-based harmonized/common reference intervals (hRIs) and support their implementation in laboratories across Canada. After comprehensive review of the literature, our group established a novel approach to reference interval harmonization in adults involving: extraction of data from outpatient community reference laboratories across Canada, 2) assessment of outliers and monthly instability, 3) statistical evaluation of age, sex, and centre-specific differences, 4) derivation of preliminary harmonized reference intervals using a new indirect method (Truncated Maximum Likelihood method), 5) comparison of established harmonized reference intervals to direct a priori data in the healthy Canadian population and 6) verification through a cross-Canada prospective program. Thus far, this approach has led to the development of harmonized reference intervals for 17 biochemical and immunochemical markers. In this presentation, we will discuss the work completed by CSCC hRI WG, challenges encountered, and future plans to support implementation.
W050945-A Optimal Therapeutic Ranges of Serum Lithium Levels in Older Adults
Sunday June 5, 0945-1115
Lei Fu, Sunnybrook Health Sciences Centre
Angela Fung, St. Paul’s Hospital
Kenneth Shulman, Sunnybrook Health Sciences Centre
Learning Objectives:
At the end of the session, the participants will be able to:
- Review the clinical evidence and ISBD task force recommendations on maintenance lithium treatment in older adults with bipolar disorder.
- Examine the literature and laboratory practice in therapeutic drug monitoring of lithium.
- Discuss the laboratory approaches to establish the optimal therapeutic ranges in older patient populations.
Lithium has been used in the treatment of bipolar disorder for many years. Due to its narrow therapeutic index, close monitoring of serum lithium-levels is warranted. Undesirable side effects may include tremor, GI upset, neurological symptoms and nephrogenic diabetes insipidus. In severe toxicity, death can occur as a consequence of neurologic and cardiovascular complications. International Society for Bipolar Disorders (ISBD) task force recommended specific lower therapeutic ranges in older adults in order to reduce the risk of side effects and neurotoxicity.
W050945-B One Clinical and Laboratory Information System: The Blood, Sweat and Cheers Towards Laboratory Standardization
Sunday June 5, 0945-1115
Jessica Boyd, Alberta Precision Laboratories
Michelle Parker, DynaLIFE Medical Labs
Albert Tsui, Alberta Precision Laboratories
Alison Venner, Alberta Precision Laboratories
Learning Objectives:
At the end of the session, the participants will be able to:
- Explain the goal and purpose of a single, province-wide clinical (CIS) and laboratory information system (LIS) in Alberta.
- Discuss the roles of clinical biochemists in planning, testing, and implementation of Epic Beaker in urban/regional/rural hospitals, community reference laboratories, and point of care testing.
- Describe the path, challenges and achievements of laboratory standardization in preanalytical, analytical and post-analytical phases for a common CIS/LIS.
- Identify areas where standardization may not always be the answer, and provide solutions to fit within the single CIS/LIS model.
- Summarize the tips, tricks and challenges in implementing one LIS with a common POCT connectivity solution.
Standardization of laboratory processes and result reporting can support equality in patient access, experience, and service. Alberta is currently rolling out a multi-year implementation of a single electronic clinical and laboratory information system (CIS, LIS) across the province with the goal to improve patient care by centralizing access to patient information, and having common clinical standards and best healthcare practices. This workshop will discuss the implementation pathway for a new provincial LIS (Epic) across Alberta’s hospital and community reference laboratories, and describe the overall experiences to-date. The workshop will: 1) provide an overview of the provincial initiative, as well as experience from hospital laboratories, 2) discuss the perspective of the community laboratory, 3) identify work required to manage various LIS in the interim and concurrent standardization efforts to support the goal of a single LIS, and 4) provide experience in building a single connectivity solution for the province that connects with the LIS and CIS. This workshop is aimed at clinical biochemists, laboratory directors, general pathologists, medical laboratory technologists and information technology analysts interested in laboratory standardization and LIS/CIS implementation.
W051300-A Actionable Insights Arising from an Algorithmic Big Data Analysis of Sequential Intrapatient Laboratory Results
Sunday June 5, 1300-1615
George Cembrowski, University of Alberta
Mark Cervinski, Dartmouth Hitchcock Medical Center; The Geisel School of Medicine at Dartmouth
Andrew Lyon, Saskatchewan Health Authority & University of Saskatchewan
Christopher McCudden, Ontario Regional Laboratory Association; University of Ottawa; The Ottawa Hospital
Learning Objectives:
At the end of the session, the participants will be able to:
- Discuss the average deltas patient-based quality control.
- Explain that virtually all blood tests demonstrate diurnal variation.
- Describe that for certain analytes within day variation can exceed between day variation.
- Explain and calculate the standard deviation of duplicates.
- Discuss that most non-hospitalists identify opportunities for machine learning in quality assurance.
- Discuss the future informatics needs in the clinical laboratory.
The determination of biological, analytical and preanalytical variations from sequential patient data for the purposes of quality control, quality assurance; reference change calculations and the optimization of test ordering and interpretation.
W051300-B Quality Assurance in Clinical Mass Spectrometry – Tools and Metrics to Address Challenges with Sample Preparation, Ion Suppression, Ongoing Validations and Result Analysis
Sunday June 5, 1300-1615
Danijela Konforte, LifeLabs
Denis Orton, Alberta Precision Laboratories
Difei Sun, LifeLabs
Learning Objectives:
At the end of the session, the participants will be able to:
- Describe key components of a QA framework for ongoing monitoring of quality in a clinical MS lab, including references to applicable guidelines.
- Select approaches and metrics for ongoing method validations in clinical MS, such as reagent lot-to-lot validations, and validations related to method updates and software upgrades.
- Learn about benefits of automation in sample preparation, data analysis, and tools to track workflow steps.
- Apply a decision-making process to determine when troubleshooting matrix effect is sufficient versus when an assay requires redevelopment.
- Utilize some tips and tricks for method redevelopment based on understanding the source of matrix effects.
Owing to their high sensitivity and selectivity, Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS) technologies are becoming increasingly common in clinical laboratories. After an LC-MS/MS method is implemented, clinical laboratories need to establish a quality assurance (QA) program that ensures the method remains fit for use on an ongoing basis. Such a QA program should take into consideration testing volumes (low/medium vs. high volume testing), sample preparation, MS data acquisition and analysis, result interpretation and reporting.
Expansion of LC-MS/MS testing comes with pressure to implement simple, low-cost, high-throughput methods with rapid turnaround times. Simplified sample preparation and extraction permits time and reagent savings, and is attractive to labs with less experience in LC-MS/MS method development. However, there is a trade-off between quality and speed with LC-MS/MS workflows, thus the established QA program must include strategies to mitigate errors related to matrix effects or possible interferences.
This workshop will identify and discuss approaches, tools and metrics for ongoing monitoring of LC-MS/MS method performance to detect and mitigate errors related to matrix effects, or during sample preparation and MS data acquisition.
Examples from published guidelines and literature, and cases from both high and mid-to-low volume laboratories will be shared and discussed. Specific case examples, and a few simple troubleshooting steps that allow reporting of patient results on-the-fly will be presented.