INTRODUCTION:Point of care testing (POCT) offers a broader selection of clinical testing outside of a central laboratory due to its many benefits, such as accessibility and rapid turn-around-time. However, it does have disadvantages and challenges, so proper utilization of POCT is vital to its success. A common area for POCT use is in the acute care setting, and improving the use and quality of POCT in this setting remains clinically important. The Canadian Society of Clinical Chemists (CSCC) POCT Special Interest Group (SIG) and Utilization Management SIG aimed to develop Choosing Wisely Canada recommendations for POCT in the acute care setting. METHODS:A working group consisting of 17 experts from the CSCC POCT and Utilization Management SIGs formed to develop recommendations to be evaluated through a two-round modified Delphi consensus survey. Survey consensus was reached if > 80% of the experts rated recommendations with a score of 4 or 5. RESULTS:A final draft of 12 recommendations were developed, with accompanying rationale and references. Choosing Wisely Canada completed their review, including review by their stakeholder national societies, which led to a finalized seven recommendations. CONCLUSIONS:A collaborative adoption of the evidence-based, seven Choosing Wisely Canada POCT recommendations in acute care settings will help support improved patient care through strong diagnostic integrity, augmented safeguards to patients, and optimization of related healthcare resources. A strong quality management system framework embedded within the implementation of these recommendations will augment the value of POCT within a sustained patient-centered acute care healthcare setting.

Hyperkalemia is a potentially life-threatening condition, with guidelines recommending urgent treatment when the serum potassium level is greater than 6.0 mmol/L. However, these recommendations are inconsistent, leading to diverse approaches to patient care. The primary objectives were to use population-based datasets to determine how often outpatient hyperkalemia (K > 6.2 mmol/L) occurs and how frequently patients present to the emergency department (ED) within 24 hours of the hyperkalemia report. Secondary objectives were to compare the characteristics of patients who had an ED encounter to those who did not, assess clinical outcomes within 7 days of the hyperkalemia report, and describe the initial potassium result within 24 hours of an ED encounter. Retrospective cohort study using linked population-based datasets at ICES. Ontario, Canada from January 1, 2007, to December 24, 2021. Adult patients (≥18 years) not on dialysis with an outpatient hyperkalemia result >6.2 mmol/L who were identified through flagged and urgently communicated results from outpatient laboratories. Emergency department encounters within 24 hours following an outpatient serum potassium report >6.2 mmol/L. Outcomes included all-cause mortality, cardiovascular mortality, arrhythmias, cardiac arrest in the ED, hospitalizations, and new dialysis starts within 7 days of the hyperkalemia report. Administrative healthcare data were linked with laboratory results to compare baseline characteristics, medication use, healthcare utilization, and clinical outcomes for all patients. Standardized differences were used for comparisons. There were over 65 million serum potassium measurements and 57 607 individuals with an outpatient hyperkalemia value >6.2 mmol/L. Of these, 7469 (13.0%) individuals had an ED encounter within 24 hours. Individuals with an ED encounter had more comorbidities, higher medication use, and more prior healthcare utilization. Within 7 days of the hyperkalemia report, 675 of the 57 607 individuals (1.2%) had died. Where data were available, the first potassium value within 24 hours of an ED encounter was 1.5 mmol/L (± SD 1.3) lower, on average, than the initial outpatient potassium value. All-cause mortality may not be attributable to the hyperkalemia result. Sudden cardiac death, which is more specific to hyperkalemia, is not completely captured in our data sources. Data for medications are limited to patients 65 years of age and older. Outpatient hyperkalemia is common. Despite guidelines recommending urgent treatment for patients with serum potassium levels >6.2 mmol/L, most are not referred to the ED.

Choosing Wisely Canada has made significant contributions to diagnostic stewardship and appropriate test ordering. Given that laboratories play a crucial role in advancing healthcare efficiency and sustainability, it is imperative to continue advocating for Choosing Wisely laboratory initiatives to minimize unnecessary testing and mitigate the associated environmental impact. Herein, we recommend the focus on two environmental impacts associated with the overuse of diagnostic laboratory tests. Firstly, collaboration with healthcare providers is essential to raise public awareness about the waste generated by performing lab tests in the absence of a clear clinical indication. Not only does unnecessary testing come with clinical and financial costs, but it also contributes significantly to a substantial carbon footprint. Patients also have a role in reducing waste by understanding when tests are truly necessary and when they might be redundant or even harmful. Secondly, laboratories should partner with in vitro diagnostic device manufacturers to prioritize environmentally conscientious solutions. This includes minimizing the use of single-use consumables, toxic chemicals, and high-energy consumption processes. Laboratories should adopt a holistic, "environmental lens" approach, scrutinizing every stage of the laboratory total testing workflow- from sample collection and transportation, to testing, reporting, and disposal-to identify areas where waste reduction and process efficiencies can be achieved. The optimization of testing workflows to eliminate unnecessary steps can lead to both environmentally sound and cost-effective operations. In summary, laboratories are in a unique position to lead the way in both improving clinical care and driving eco-friendliness in healthcare. By aligning with Choosing Wisely initiatives and focusing on greener practices, laboratories can lead the way in improving both patient care and environmental sustainability.

Detecting dyslipidemia early is important because atherosclerosis originates in childhood and early treatment can improve outcomes. In 2022, CCS/CPCA published a Clinical Practice Update to detect, evaluate, and manage pediatric dyslipidemia. However, guidance on its translation into clinical laboratories is lacking. The Canadian Society of Clinical Chemists (CSCC) Working Group on Reference Interval Harmonization (hRI-WG) Lipid Team aims to aid guideline implementation and promote harmonized pediatric lipid reporting across Canada. The 2022 CCS/CPCA Clinical Practice Update, 2011 NHLBI Integrated Guidelines, and new data analysis (Canadian pediatric reference values from the Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) and retrospective patient data from large community laboratories) were incorporated to develop five key recommendations. These include recommendations to 1) offer both non-fasting and fasting lipid testing; 2) offer a lipid panel including total cholesterol, LDL-C, HDL-C, non-HDL-C and triglycerides, with ApoB and Lp(a) available as individually orderable tests; 3) flag total cholesterol, LDL-C, and non-HDL-C results ≥95th percentile, and HDL-C results <10th percentile, as recommended by CCS/CPCA/NHLBI and validated by CALIPER, and flag ApoB and non-fasting triglyceride results ≥95th percentile based on CALIPER, and do not flag Lp(a) results but mention the adult cut-off in the interpretive comments; 4) implement interpretive comments listed in the current report; and 5) implement the NIH LDL-C equation. The CSCC hRI-WG Lipid Team will support clinical laboratories to implement these recommendations using knowledge translation strategies. Harmonizing pediatric lipid reporting across Canadian clinical laboratories will optimize clinical decision-making and improve cardiovascular risk management in youth.

Background Harmonization in laboratory medicine is essential for consistent and accurate clinical decision-making. There is significant and unwarranted variation in reference intervals (RIs) used by laboratories for assays with established analytical traceability. The Canadian Society of Clinical Chemists (CSCC) Working Group on Reference Interval Harmonization (hRI-WG) aims to establish harmonized RIs (hRIs) for laboratory tests and support implementation. Methods Harnessing the power of big data, laboratory results were collected across populations and testing platforms to derive common adult RIs for 16 biochemical markers. A novel comprehensive approach was established, including: (a) analysis of big data from community laboratories across Canada; (b) statistical evaluation of age, sex, and analytical differences; (c) derivation of hRIs using the refineR method; and (d) verification of proposed hRIs across 9 laboratories with different instrumentation using serum and plasma samples collected from healthy Canadian adults. Results Harmonized RIs were calculated for all assays using the refineR method, except free thyroxine. Derived hRIs met proposed verification criterion across 9 laboratories and 5 manufacturers for alkaline phosphatase, albumin (bromocresol green), chloride, lactate dehydrogenase, magnesium, phosphate, potassium (serum), and total protein (serum). Further investigation is needed for some analytes due to failure to meet verification criteria in one or more laboratories (albumin [bromocresol purple], calcium, total carbon dioxide, total bilirubin, and sodium) or concern regarding excessively wide hRIs (alanine aminotransferase, creatinine, and thyroid stimulating hormone). Conclusions We report a novel data-driven approach for RI harmonization. Findings support feasibility of RI harmonization for several analytes; however, some presented challenges, highlighting limitations that need to be considered in harmonization and big data analytics.

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 lab-oratories. 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 per-forming 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.

There is limited guidance on laboratory reporting and interpretation of lipids and lipoproteins used in cardiovascular risk stratification. This contributes to inconsistencies in lipid reporting across clinical laboratories. Recently, the Canadian Cardiovascular Society (CCS) published the 2021 CCS guidelines for the management of dyslipidemia for the prevention of cardiovascular disease in the adult. A subcommittee of the Working Group on Reference Interval Harmonization of the Canadian Society of Clinical Chemists has developed harmonized lipid reporting recommendations that are aligned with the 2021 CCS guidelines, to improve the standardization of lipid assessment and clinical decision-making. The proposed harmonized lipid reporting recommendations were critically reviewed by a broad range of laboratory and clinical experts across Canada. Feedback from approximately 30 expert reviewers was reviewed by the Working Group on Reference Interval Harmonization lipid subcommittee, and consensus decisions were incorporated into the 2021 harmonized lipid reporting recommendations. In this position statement, we provide 6 recommendations for laboratory reporting of lipid parameters. These recommendations include implementing the new National Institutes of Health equation to replace the Friedewald equation for calculating low-density lipoprotein cholesterol, offering lipoprotein (a), either as an in-house or send-out test, and using assays that report lipoprotein (a) in molar units (nmol/L). We also developed a harmonized lipid reporting format with interpretive comments that includes flagging results based on screening patients using treatment decision thresholds in a primary prevention setting. Overall, harmonized lipid reporting will help bridge the gap between clinical guideline recommendations and clinical laboratory reporting and interpretation, and will improve cardiovascular risk assessment across Canada.

AbstractThe COVID-19 pandemic has significantly impacted the production, distribution, and demand of essential laboratory supplies worldwide. In 2021, severe shortages in required laboratory supplies such as blood collection tubes, butterfly needles, and blood gas syringes became a critical issue across Canada. Many hospitals or institutions had to instruct physicians and patients to limit laboratory testing where possible and, in some cases, required emergency shipments of tubes from alternative vendors or nearby hospitals. Laboratory testing is ubiquitous in managing patients. It is used for screening, diagnosis, and monitoring purposes. With limited blood collection tubes, consideration for restricting non-urgent testing is needed to conserve supply and protect acute care departments that manage critically ill patients. In addition, laboratories across Canada have experienced significant staffing shortages, resulting in an even greater need for appropriate laboratory utilization. Consequently, the Canadian Society of Clinical Chemists (CSCC) and the Canadian Association of Medical Biochemists (CAMB) curated utilization recommendations for both hospital and primary care settings in collaboration with Choosing Wisely Canada (CWC). These recommendations were specifically selected from those previously published by Choosing Wisely Canada (CWC), with impact statements and rationales added to conserve at-risk laboratory resources. Supply chain disruptions of clinical laboratory resources are expected to continue throughout 2022, indicating that now, more than ever, a focus on appropriate laboratory utilization is essential. RésuméLa pandémie de COVID-19 a eu un impact considérable sur la production, la distribution et la demande de fournitures de laboratoire essentielles dans le monde entier. À partir de 2021, de graves pénuries de fournitures de laboratoire essentielles, comme les tubes pour prélèvement sanguin, les aiguilles à ailettes et les seringues pour l’analyse de gaz sanguin, sont devenues un question cruciale au Canada. De nombreux hôpitaux et étab-lissements ont dû demander aux médecins et aux patients de limiter dans la mesure du possible les analyses en laboratoire et, dans certains cas, ont eu besoin qu’on leur envoie d’urgence des tubes provenant d’autres fournis-seurs ou d’hôpitaux voisins. Les analyses en laboratoire sont omniprésentes dans la prise en charge des patients et sont utilisées à des fins de dépistage, de diagnostic et de suivi. Étant donné le nombre limité de tubes pour prélèvement sanguin, il faut envisager de restreindre les analyses non urgentes pour conserver les réserves et protéger les services de soins de courte durée qui prennent en charge les patients gravement malades. De plus, partout au Canada, les laboratoires connaissent des pénuries importantes de personnel, ce qui rend encore plus nécessaire une utilisation appropriée des laboratoires. Par conséquent, la Société canadienne des clini-co-chimistes (SCCC) et l’Association des médecins biochimistes du Canada (CAMB), en collaboration avec Choisir avec soin (CAS), ont préparé des recommandations d’utilisation pour les milieux hospitaliers et de soins de santé primaires. Ces recommandations ont été spécifiquement choisies à partir de celles déjà publiées par CAS, en y ajoutant des énoncés des répercussions et des justifications, et visent à conserver les ressources de laboratoire à risque. On s’attend à ce que les perturbations de la chaîne d’approvisionnement en ressources de laboratoire clinique se poursuivent tout au long de l’année 2022, ce qui indique que maintenant, plus que jamais, il est essentiel de se concentrer sur une utilisation appropriée des laboratoires.

Objectives: Testing for renin and aldosterone in clinical laboratories is complicated by pre-analytical considerations such as the posture for blood collection and susceptibility to cryoactivation of renin. From an analytical perspective, there are both renin activity and renin mass or concentration assays available. There can also be variability in result reporting practices and the aldosterone-renin ratio (ARR) cut-off applied to screen for primary aldosteronism (PA). The Institute for Quality Management in Healthcare (IQMH) Centre for Proficiency Testing surveyed laboratories on their handling of renin and aldosterone testing to better understand current practices. Design and methods: An online survey was prepared and sent to 134 Canadian laboratories enrolled in endocrinology proficiency testing with IQMH. Results: One hundred twenty Ontario laboratories submitted responses. While only six (5%) laboratories perform testing for both renin and aldosterone, 108 (90%) collect and process specimens to be tested by reference laboratories. The survey revealed considerable variation in practices including the recommended state of patients prior to sample collection (for example, regarding medications or salt intake), the patient posture specifications for sample collection, the precautions taken against cryoactivation of renin, the choice of renin activity or mass assay, and the ARR cut-off used. The available literature on these factors was then reviewed. Conclusions: Although there is no standardized procedure for specimen collection, analysis, or result reporting for renin or aldosterone testing, we have attempted to summarize the available literature to develop evidence-based recommendations. Where laboratory practice differs from peers and/or recommended protocols, laboratories should review their practices.

To effectively implement the Canadian Cardiovascular Society (CCS) guidelines for dyslipidemia management into clinical laboratories, clear recommendations for lipid reporting are essential. In this study, the Canadian Society of Clinical Chemists Working Group on Reference Interval Harmonisation surveyed Canadian laboratories on adult lipid reporting practices to set a foundation for the development and implementation of harmonised lipid reporting across Canada. Key aspects of the survey asked laboratories: what reporting parameters were in place to assess lipid results; what interpretative comments were provided; whether nonfasting lipids were permitted and, if so, what strategy was used to document fasting status; and whether there was interest in implementing a harmonised lipid report. A total of 101 laboratories were represented by 24 respondents, as many responses were submitted by laboratory networks that included more than 1 laboratory. There was at least 1 response from 9 Canadian provinces and representation across 5 testing platforms. Upper and lower limits for lipid parameters and referenced source of limits varied substantially across laboratories, with only 56% of laboratories (9 respondents) referencing the 2016 CCS guidelines. Eighty-six per -cent of laboratories (19 respondents) report nonfasting lipids, although the method of documenting nonfasting status varied. Overall, 36% of laboratories (8 respondents) reported interest in implementing a harmonised lipid report. Assessment of current lipid-reporting practices supports the need for harmonised lipid reporting across Canada. Development of a harmonised lipid report for the adult population, consistent with up-to-date Cana-dian guidelines, will improve continuity of lipid test interpretation across Canada and improve clinical decision making.

OBJECTIVES:A consensus guidance is provided for testing, utility and verification of SARS-CoV-2 point-of-care test (POCT) performance and implementation of a quality management program, focusing on nucleic acid and antigen targeted technologies.DESIGN AND METHODS:The recommendations are based on current literature and expert opinion from the members of Canadian Society of Clinical Chemists (CSCC), and are intended for use inside or outside of healthcare settings that have varied levels of expertise and experience with POCT.RESULTS AND CONCLUSIONS:Here we discuss sampling requirements, biosafety, SARS-CoV-2 point-of-care testing methodologies (with focus on Health Canada approved tests), test performance and limitations, test selection, testing utility, development and implementation of quality management systems, quality improvement, and medical and scientific oversight.

KEY POINTS Clinical presentation in persons infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ranges from asymptomatic to the life-threatening respiratory distress that can occur with coronavirus disease 2019 (COVID-19).[1][1] Diagnosis of acute or new cases of SARS-CoV-2