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Purpose of Review: The Choosing Wisely® initiative, led by the American Board of Internal Medicine Foundation in collaboration with national professional medical societies, aims to help patients choose care that is essential, free from harm, and evidence-based. The American Society of Hematology has advocated practices specific to hematology for physicians and patients to examine carefully. Here, we summarize various barriers to adopting these practices, interventions used to improve adoption, and challenges in measuring the effectiveness of these interventions., Recent Findings: The Choosing Wisely® campaign has become an international effort with more than 20 countries worldwide having embraced it. Such widespread interest indicates that the campaign initiated an important dialog between patients and physicians about overutilization of resources. Evidence showing the positive impact of interventions on adopting these practices is accumulating, but their effect on improving clinical outcomes is uncertain. Decreasing overuse of resources is a cultural change in perspective for practitioners and patients alike. We believe that healthcare delivery is transitioning from being volume-based to value-based. As we continue to support the Choosing Wisely® campaign, we need to implement strategies to document and measure the influence of our value-based recommendations on physician practices, patient care and attitudes, and healthcare costs.

Purpose of Review: Despite national-level directives to reduce healthcare waste and promote high-value care (HVC), clinical educators struggle to equip trainees with the knowledge and skills needed to practice value-based care. In this review, we analyze ongoing efforts in graduate medical education (GME) to enhance trainee competence in delivery of high-value and cost-conscious care., Recent Findings: Surveys of residents and program directors have shown that while many training programs want to offer formal training in high-value care delivery, few succeed. Although several studies suggest that trainees model stewardship behaviors after clinical preceptors, there remains a shortage of faculty role models skilled in providing HVC. Preparing future hematologist-oncologists to provide cost-conscious care will require significant cultural change at the institutional and program levels and will depend heavily on the development of skilled clinical role models.

Purpose of Review: This review discusses important findings from real-world evidence (RWE) studies impacting the field of chronic lymphocytic leukemia (CLL), from prognostication to long-term management and sequencing of novel agents., Recent Findings: RWE data, which represents a heterogeneous cohort of patients treated at non-academic centers and off-clinical trial, demonstrate several key differences between findings in randomized controlled trials (RCT) of novel agents in CLL. While toxicity and discontinuation rates are higher, survival outcomes are encouraging in clinical practice, with often equivalent outcomes from reduced-dose or time-limited therapy of drug. Though sequencing of novel agents lacks robust RCT data, RWE data provide important guidance for selection and sequencing of novel agents. RWE has critically informed our practice by providing diverse patient data and real-time analysis for important clinical questions outpacing the rapidly growing field of CLL.

Introduction: A pandemic coronavirus, SARS-CoV-2, causes COVID-19, a potentially life-threatening respiratory disease. Patients with cancer may have compromised immunity due to their malignancy and/or treatment, and may be at elevated risk of severe COVID-19. Community transmission of COVID-19 could overwhelm health care services, compromising delivery of cancer care. This interim consensus guidance provides advice for clinicians managing patients with cancer during the pandemic., Main Recommendations: During the COVID-19 pandemic: In patients with cancer with fever and/or respiratory symptoms, consider causes in addition to COVID-19, including other infections and therapy-related pneumonitis. For suspected or confirmed COVID-19, discuss temporary cessation of cancer therapy with a relevant specialist. Provide information on COVID-19 for patients and carers. Adopt measures within cancer centres to reduce risk of nosocomial SARS-CoV-2 acquisition; support population-wide social distancing; reduce demand on acute services; ensure adequate staffing; and provide culturally safe care. Measures should be equitable, transparent and proportionate to the COVID-19 threat. Consider the risks and benefits of modifying cancer therapies due to COVID-19. Communicate treatment modifications, and review once health service capacity allows. Consider potential impacts of COVID-19 on the blood supply and availability of stem cell donors. Discuss and document goals of care, and involve palliative care services in contingency planning., Changes in Management as a Result of This Statement: This interim consensus guidance provides a framework for clinicians managing patients with cancer during the COVID-19 pandemic. In view of the rapidly changing situation, clinicians must also monitor national, state, local and institutional policies, which will take precedence., Endorsed by: Australasian Leukaemia and Lymphoma Group; Australasian Lung Cancer Trials Group; Australian and New Zealand Children's Haematology/Oncology Group; Australia and New Zealand Society of Palliative Medicine; Australasian Society for Infectious Diseases; Bone Marrow Transplantation Society of Australia and New Zealand; Cancer Council Australia; Cancer Nurses Society of Australia; Cancer Society of New Zealand; Clinical Oncology Society of Australia; Haematology Society of Australia and New Zealand; National Centre for Infections in Cancer; New Zealand Cancer Control Agency; New Zealand Society for Oncology; and Palliative Care Australia., (© 2020 AMPCo Pty Ltd.)

Despite huge progress in the fields of newborn screening, encapsulated bacterial infection prophylaxis, immunization, and supportive care in general, people suffering from sickle cell anemia still continue to have a shorter life expectancy and a poorer quality of life due to painful vaso-occlusive events and strokes during childhood, and later, cardiac, pulmonary, and renal injuries, including in Western and high-income countries. From the 2000s, allogeneic stem cell transplantation for severe sickle cell disease from a sibling donor provided the best results-overall as well as disease-free survival-never obtained for any other disease. Nevertheless, this only curative option is proposed to few patient numbers, including in Western countries with high-level medical equipment development, with discrepancies between (i) patients and family, (ii) physicians and care centers dedicated to sickle cell disease, and (iii) hematopoietic stem cell transplant teams. Due to these discrepancies and in order to provide the same quality of discussion and treatment choice for every sickle cell disease patient, we developed a National French multidisciplinary pluri-annual meeting dedicated to sickle cell disease patients and transplantation. We report here our experience of such a meeting., Competing Interests: Declaration of Competing Interest The author has no conflicts of interest to declare., (Copyright © 2020 King Faisal Specialist Hospital & Research Centre. Published by Elsevier Ltd. All rights reserved.)

Cancer in children and adolescents under the age of 18 is rare; in 2017, approximately 2220 new cases in Germany were reported to the German Childhood Cancer Registry. The aim of the GPOH has always been to treat as many affected patients as possible in a standardized way, preferably in prospective, controlled studies. The Joint Federal Committee has also laid down this requirement in the paediatric oncology guideline. In a survey among the study chairs of the GPOH, it was determined how the number of clinical trials has changed following the amended drug legislation. In 2002, 33 therapy optimization studies (TOS) of the GPOH were open. Overall, TOS decreased from 33 in 2002 to 2 in 2017. The number of drug trials has increased to 16 by 2017 (almost 1100 patients registered). At the time, the number of clinical registries has increased to 28 with a total of more than 1800 registered patents. This observation shows that the clinical registers have taken on a new significance in paediatric oncology. Three examples are used to examine what contributions registries can make in relation to studies on the treatment of patients and to scientific progress. In summary, the experience gained so far from the examples discussed illustrates that studies and registries mutually represent a meaningful and necessary addition to the study group structure in paediatric oncology., Competing Interests: Die Autorinnen/Autoren geben an, dass kein Interessenkonflikt besteht., (© Georg Thieme Verlag KG Stuttgart · New York.)

Background: Hematology analysis is a common test among patients in hospital. However, manual verification of hematology analysis is time consuming and tedious, with variation between inter-individual laboratory workers. This study was to establish and validate a set of autoverification rules for hematology analysis in the department of laboratory medicine, Zhongshan Hospital of Sun Yatsen University., Methods: Hematology analysis was measured by a Sysmex XN-9000 hematology system in the Department of Laboratory Medicine, Zhongshan Hospital of Sun Yatsen University. SYSMEX Laboman EasyAccess 6.0 and the laboratory information system were used to construct the algorithm and design the autoverification rules of hematology analysis according to Clinical and Laboratory Standards Institute document Auto 10A and 41 rules of Hematology Review Criteria. The laboratory turnaround time (TAT), autoverification pass rates, false positive, false negative, and the average error rate were verified after implementing autoverification rules., Results: Approximate 1,300 specimens were collected daily and transferred to our laboratory for hematology analysis; that is necessary to build a database and to design autoverification rules. The average autoverification passing rate was 81%; the false positive rate was 13.6%; the false negative rate and the average error rate was nearly zero, indicating that incorrect reports were almost eliminated. Moreover, since implementing autoverification, the TAT was reduced by 27.0% in in-patient reports, by 21.9% in out-patient reports, and by 39.0% in emergency reports, which enhanced the productivity in our laboratory., Conclusions: Our laboratory accelerated verification and decreased TAT and the odds of human review errors in the released results since implementing the autoverification. Thus, we can save more time and concentrate on verifying the abnormal results and processing emergency tests.

This is a prospective study realized at the level of the hematology department and blood transfusion center of the University Hospital Center (CHU) of Dr Ben Badis of Constantine and spread out over a period of one year (from January 1st to December 31st). The work focused on the analytical processes mastery of the NFS needs a compulsory step concerning technical and organizational laboratory skills respecting the ISO 15189 laws going through a mastery of support processes (humain resourses, informatics, materials, documents, management) indispensable for the good function of analytic proceedings, a performance evaluation of the hematology analyzer Advia (2120 I and II and 560) and quality control management (intern, extern). The analytic performance evaluation of Advia gives reliable results reproductible and stable for use of the routine automatisation good inter-machine correlation and laboratory performance in terms of the quality extern evaluation with military hospital laboratory.

Introduction: Biosimilar drugs have significantly shaken the global pharmaceutical market through a better access to the health care services. The aim of this study is to establish a state of play in Tunisia based on the knowledge and perceptions of doctors on biosimilars in order to identify the problems related to these drugs and to propose solutions for improvement., Materials and Methods: In our study, we conducted a prospective, descriptive survey using a questionnaire, destinated to oncologists and hematologists with different grades, from both public and private sectors and from several regions. The questions focused on physicians' general knowledge of biosimilars and their comparison with reference on safety, quality, efficacy, and indication. Finally, we explored the proportion of physicians who are favorable to the policy encouraging biosimilar use., Results: One hundred and seven doctors among 150 answered the questionnaire; 57% were oncologists and 43% were hematologists. About one over five physicians defines biosimilar as a chemical drug. About 29% do not differentiate between a biosimilar and a generic one. A percentage of 68 believe that a biosimilar can have all the indications of its reference following complementary clinical studies. On the other side, 68.2% support the policy encouraging these drugs. Last, only 3.7% of the practitioners believe that they are well informed about biosimilars., Discussion: Our results are comparable to other surveys described in the literature. However, this is the first study that targets oncologists and hematologists specifically., Conclusion: Our study showed a lack of information from oncologists and hematologists about biosimilars in Tunisia. Thus, health authorities should carry out training programs on biosimilars and introduce clear and effective legislation in order to allow better access to health care services.

Purpose: Due to decades of nonstandardized approaches to the naming of chemotherapy regimens, representation in electronic health records and secondary systems is highly variable. This hampers efforts to understand patterns of chemotherapy usage at the population level. In this article, we describe a proposal for rules to standardize the nomenclature of chemotherapy regimens and illustrate applications of these rules., Methods: Through our experience with building HemOnc.org, which has been under construction since 2011, we formulated a set of guidelines and recommendations for the standard representation of chemotherapy regimen names. We then performed a mapping between the HemOnc and National Cancer Institute Thesaurus vocabulary's regimens and evaluated conformance with the naming conventions. Finally, we assembled a database of acronyms and names for multiple myeloma regimens to illustrate the scope of the problem., Results: For the first use case, 242 of 527 (45.1%) of the regimen names differed. The schema was able to allocate a preferred source for 217 (89.4%) of these regimens. For the second use case, we expanded 130 multiple myeloma regimens to 1,138 unique regimen names and demonstrate ways in which the schema can collapse these into disambiguated, but abbreviated, regimen names., Conclusion: To our knowledge, this is the first proposal to normalize chemotherapy regimen nomenclature. If our recommendations are adopted, we expect that the uniformity of treatment exposure representation in hematology/oncology will increase, which will enable large-scale efforts such as ASCO's CancerLinQ to achieve better standardization.

The American Society of Hematology (ASH) convened 5 guideline panels to develop clinical practice recommendations addressing 5 management areas of highest importance to individuals living with sickle cell disease: pain, cerebrovascular complications, pulmonary and kidney complications, transfusion, and hematopoietic stem cell transplant. Panels were multidisciplinary and consisted of patient representatives, content experts, and methodologists. The Mayo Clinic Evidence-Based Practice Center conducted systematic reviews based on a priori selected questions. In this exposition, we describe the process used by ASH, including the GRADE approach (Grades of Recommendations, Assessment, Development and Evaluation) for rating certainty of the evidence and the GRADE Evidence to Decision Framework. We also describe several unique challenges faced by the guideline panels and the specific innovations and solutions used to address them, including a curriculum to train patients to engage in guideline development, dealing with the opioid crisis, and working with indirect and noncomparative evidence.

Background: Prevention and management of end-organ disease represent major challenges facing providers of children and adults with sickle cell disease (SCD). Uncertainty and variability in the screening, diagnosis, and management of cardiopulmonary and renal complications in SCD lead to varying outcomes for affected individuals., Objective: These evidence-based guidelines of the American Society of Hematology (ASH) are intended to support patients, clinicians, and other health care professionals in their decisions about screening, diagnosis, and management of cardiopulmonary and renal complications of SCD., Methods: ASH formed a multidisciplinary guideline panel that included 2 patient representatives and was balanced to minimize potential bias from conflicts of interest. The Mayo Evidence-Based Practice Research Program supported the guideline development process, including performing systematic evidence reviews up to September 2017. The panel prioritized clinical questions and outcomes according to their importance for clinicians and patients. The panel used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, including GRADE evidence-to-decision frameworks, to assess evidence and make recommendations, which were subject to public comment., Results: The panel agreed on 10 recommendations for screening, diagnosis, and management of cardiopulmonary and renal complications of SCD. Recommendations related to anticoagulation duration for adults with SCD and venous thromboembolism were also developed., Conclusions: Most recommendations were conditional due to a paucity of direct, high-quality evidence for outcomes of interest. Future research was identified, including the need for prospective studies to better understand the natural history of cardiopulmonary and renal disease, their relationship to patient-important outcomes, and optimal management., (© 2019 by The American Society of Hematology.)

Background: Despite an increase in the number of therapies available to treat patients with immune thrombocytopenia (ITP), there are minimal data from randomized trials to assist physicians with the management of patients., Objective: These evidence-based guidelines of the American Society of Hematology (ASH) are intended to support patients, clinicians, and other health care professionals in their decisions about the management of ITP., Methods: In 2015, ASH formed a multidisciplinary guideline panel that included 8 adult clinical experts, 5 pediatric clinical experts, 2 methodologists with expertise in ITP, and 2 patient representatives. The panel was balanced to minimize potential bias from conflicts of interest. The panel reviewed the ASH 2011 guideline recommendations and prioritized questions. The panel used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, including evidence-to-decision frameworks, to appraise evidence (up to May 2017) and formulate recommendations., Results: The panel agreed on 21 recommendations covering management of ITP in adults and children with newly diagnosed, persistent, and chronic disease refractory to first-line therapy who have non-life-threatening bleeding. Management approaches included: observation, corticosteroids, IV immunoglobulin, anti-D immunoglobulin, rituximab, splenectomy, and thrombopoietin receptor agonists., Conclusions: There was a lack of evidence to support strong recommendations for various management approaches. In general, strategies that avoided medication side effects were favored. A large focus was placed on shared decision-making, especially with regard to second-line therapy. Future research should apply standard corticosteroid-dosing regimens, report patient-reported outcomes, and include cost-analysis evaluations., (© 2019 by The American Society of Hematology.)

Background: Venous thromboembolism (VTE) is a common source of perioperative morbidity and mortality., Objective: These evidence-based guidelines from the American Society of Hematology (ASH) intend to support decision making about preventing VTE in patients undergoing surgery., Methods: ASH formed a multidisciplinary guideline panel balanced to minimize bias from conflicts of interest. The McMaster University GRADE Centre supported the guideline-development process, including performing systematic reviews. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to assess evidence and make recommendations, which were subject to public comment., Results: The panel agreed on 30 recommendations, including for major surgery in general (n = 8), orthopedic surgery (n = 7), major general surgery (n = 3), major neurosurgical procedures (n = 2), urological surgery (n = 4), cardiac surgery and major vascular surgery (n = 2), major trauma (n = 2), and major gynecological surgery (n = 2)., Conclusions: For patients undergoing major surgery in general, the panel made conditional recommendations for mechanical prophylaxis over no prophylaxis, for pneumatic compression prophylaxis over graduated compression stockings, and against inferior vena cava filters. In patients undergoing total hip or total knee arthroplasty, conditional recommendations included using either aspirin or anticoagulants, as well as for a direct oral anticoagulant over low-molecular-weight heparin (LMWH). For major general surgery, the panel suggested pharmacological prophylaxis over no prophylaxis, using LMWH or unfractionated heparin. For major neurosurgery, transurethral resection of the prostate, or radical prostatectomy, the panel suggested against pharmacological prophylaxis. For major trauma surgery or major gynecological surgery, the panel suggested pharmacological prophylaxis over no prophylaxis.

Older adults represent the growing majority of patients diagnosed with hematologic disorders, yet they remain underrepresented on clinical trials. Older patients of the same chronologic age differ from one another with varying comorbidity and functional reserve. The concepts of frailty and resilience are important to patient-centered care and are patient and setting specific. The use of geriatric assessment to inform tailored decision making and management can personalize care for older adults with hematologic malignancies. This article will highlight available evidence to support the role of geriatric assessment measures to enhance quality of care for older adults diagnosed with hematologic malignancies., Competing Interests: Conflict-of-interest disclosure: H.D.K. declares no competing financial interests., (© 2019 by The American Society of Hematology. All rights reserved.)

Background External quality assessment programs are one of the currently available tools to evaluate the analytical performance of clinical laboratories, where the measurement error (ME) obtained can be compared with quality specifications to evaluate possible deviations. The objective of this work was to analyze the ME behavior over the analytical range to assess the need to establish concentration-dependent specifications. Methods A total of 389,000 results from 585 laboratories and 2628 analyzers were collected from the Spanish external quality assessment schemes (EQAS) in hematology during the years 2015-2016. The parameters evaluated included white blood cells, red blood cells, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelets, prothrombin time, activated partial thromboplastin time, neutrophils, lymphocytes, monocytes, eosinophils, basophils, reticulocytes, hemoglobin A2, antithrombin, factor VIII, protein C and von Willebrand factor. The 90th percentile of ME was calculated for every concentration evaluated of each parameter. Results We found a significant variation in the analytical performance of leukocytes, platelets, neutrophils, lymphocytes, monocytes, eosinophils, basophils, prothrombin time, reticulocytes, hemoglobin A2, antithrombin and protein C. Furthermore, this ME variation may not allow complying with the same biological variability requirements within the whole analytical range studied. Conclusions Our work shows the importance of implementing concentration-dependent specifications which can help laboratories to use proper criteria for quality specifications selection and for a better external quality control results evaluation.

Background: Laboratory analyses of blood samples are essential for diagnostics and therapy monitoring of patients with bleeding and thromboembolic diseases. Following publication of the core curriculum for clinical thrombosis and hemostasis, the International Society on Thrombosis and Haemostasis (ISTH) recognized that thrombosis and hemostasis laboratory specialists require distinct competencies that differ from medical doctors working clinically with patients. To address this gap the ISTH formed a working group of international hemostasis and thrombosis laboratory specialists to develop an evidence-based core curriculum for laboratory specialists., Objective: This research sought consensus from the international community on core competencies required for laboratory specialists in thrombosis and hemostasis., Methods: A draft list of 64 competencies was developed and an online stakeholder survey was circulated electronically to 15 302 ISTH members and contacts in the wider international community. The results were analyzed and used to develop the final approved core curriculum., Results: Three hundred and thirty responses contained meaningful data, with broad international representation of specialists. No draft competencies were excluded, and 58 were rated as "does" or "shows how." The Leik measure of consensus for most competences was "moderate" (n = 30) or "fair" (n = 32)., Conclusions: The development of an international core curriculum for laboratory specialists provides a foundation for the development and enhancement of education and quality management of the laboratory. Although there is no formal designation for laboratory specialists, international governing bodies and regulatory organizations are encouraged to consider the diagnostic core curriculum for development and accreditation of more standardized educational programs and formal assessment across jurisdictions., (© 2019 International Society on Thrombosis and Haemostasis.)

A staging system was developed a decade ago for patients with Waldenström's macroglobulinemia (WM), however, since then WM treatments have changed. A revised staging system could better capture prognosis of WM patients in the chemoimmunotherapy era. We developed a revised system based on data from 492 symptomatic patients with at least 3 years and a median of 7 years of follow up while an independent validation cohort included 229 symptomatic patients. We identified age (≤65 vs 66-75 vs ≥76 years), b2-microglobulin ≥ 4 mg/L, serum albumin <3.5 gr/dl, and LDH ≥ 250 IU/L (ULN < 225) to stratify patients in five different prognostic groups and identify a very-low risk as well as a very-high risk group with a 3-year WM-related death rate of 0, 10, 14, 38, and 48% (p < 0.001) and 10-year survival rate of 84, 59, 37, 19, and 9% (p < 0.001). We evaluated this staging system separately in patients >65 years and <65 years, according to the reason for initiation of treatment, among patients receiving frontline rituximab or in patients treated primarily without rituximab. With further validation before clinical use, this revised IPSSWM could improve WM patient risk stratification, is easily available and may be used in the everyday practice to provide prognostic information.

We implemented a guideline for appropriate acid suppressant use in hematology-oncology patients. This intervention resulted in a sustained reduction in proton pump inhibitor (PPI) use without an increase in rates of gastrointestinal bleeding. Practice guidelines are effective in reducing PPI use, which is associated with risk of Clostridioides difficile infection.

Objectives: Hematopathology (HP) is a rapidly changing field with insufficient data to provide guidance to program directors (PDs), the Accreditation Council for Graduate Medical Education, or the American Board of Pathology., Methods: Two surveys were performed-one for HP PDs and one, given twice, for HP diplomates doing Maintenance of Certification/Continuing Certification reporting in 2017 to 2018., Results: Bone marrow (BM), lymph node (LN), and flow cytometry interpretations and peripheral blood/fluid reviews are performed by more than 80% of hematopathologists and are the areas with the greatest amount of training. A smaller proportion of hematopathologists is involved in other HP-related activities. Most PDs believed fellows should perform BM procedures. Interpretation of 400 or more LNs and 500 BMs was PDs' median expectations for fellows. PDs and HP diplomates considered coagulation and benign RBC disorders overemphasized on the certification examination., Conclusions: These results highlight how varied the practice of HP is and can provide guidance to HP PDs, those responsible for assessing HP programs, and the American Board of Pathology., (© American Society for Clinical Pathology, 2019. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Ves-Matic CUBE 200 is an automated erythrocyte sedimentation rate (ESR) analyser based on the modified Westergren principle of measurement. In this study, we aimed to assess its analytical performance following the key points addressed by the International Council for Standardization in Haematology and the comparability with the gold standard Westergren method. Comparison of the two methods yielded a correlation coefficient of 0.852, no significant bias and a small constant difference between compared results. Intrarun coefficients of variation (CV) ranged from 2.2% to 22.2%, the higher being for lower ESR values, while inter-run CVs were 19.7% for the normal range and 3.0% for the abnormal range. This study proved the analytical validity of the Ves-Matic CUBE 200 and its high comparability with the Westergren method, showing obvious improvements in the technology applied for automated determination of ESR and a valuable step forward in standardisation of ESR methods., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.)

Background Interpreting hematology analytes in children is challenging due to the extensive changes in hematopoiesis that accompany physiological development and lead to pronounced sex- and age-specific dynamics. Continuous percentile charts from birth to adulthood allow accurate consideration of these dynamics. However, the ethical and practical challenges unique to pediatric reference intervals have restricted the creation of such percentile charts, and limitations in current approaches to laboratory test result displays restrict their use when guiding clinical decisions. Methods We employed an improved data-driven approach to create percentile charts from laboratory data collected during patient care in 10 German centers (9,576,910 samples from 358,292 patients, 412,905-1,278,987 samples per analyte). We demonstrate visualization of hematology test results using percentile charts and z-scores (www.pedref.org/hematology) and assess the potential of percentiles and z-scores to support diagnosis of different hematological diseases. Results We created percentile charts for hemoglobin, hematocrit, red cell indices, red cell count, red cell distribution width, white cell count and platelet count in girls and boys from birth to 18 years of age. Comparison of pediatricians evaluating complex clinical scenarios using percentile charts versus conventional/tabular representations shows that percentile charts can enhance physician assessment in selected example cases. Age-specific percentiles and z-scores, compared with absolute test results, improve the identification of children with blood count abnormalities and the discrimination between different hematological diseases. Conclusions The provided reference intervals enable precise assessment of pediatric hematology test results. Representation of test results using percentiles and z-scores facilitates their interpretation and demonstrates the potential of digital approaches to improve clinical decision-making.

Background In a generalist laboratory, the integration of the data obtained from hematology analyzers (HAs) with those from multiparametric flow cytometry (FMC) could increase the specificity and sensitivity of first level screening to identify the pathological samples. The aim of this study was to perform a preliminary evaluation of a new simple hybrid method (HM). The method was obtained by integration between HAs reagents into FCM, with a basic monoclonal antibodies panel for the leukocytes differential count. Methods Eighty-one peripheral blood samples, collected in K3EDTA tubes, were analyzed by XN-module, and CyFlow Space System, using both standard MoAbs and HM method analysis, and with the optical microscopy (OM). Within-run imprecision was carried out using normal samples, the carryover was evaluated, data comparison was performed with Passing-Bablok regression and Bland-Altman plots. Results The within-run imprecision of HM methods ranged between 1.4% for neutrophils (NE) and 10.1% for monocytes (MO) always equal or lower to the OM. The comparison between HM methods vs. OM shows Passing-Bablok regression slopes comprised between 0.83 for lymphocyte (LY) and 1.14 for MO, whilst the intercepts ranged between -0.18 for NE and 0.25 for LY. Bland-Altman relative bias was comprised between -12.43% for NE, and 19.77% for eosinophils. In all 11 pathological samples the agreement between the methods was 100%. Conclusions The new hybrid method generates a leukocytes differential count suitable for routine clinical use and it is also useful for identifying morphological abnormalities with a reduction in cost and improvement of screening for first level hematology workflow.

Professional certification validates nurses' knowledge and expertise in their specialty. In support of professional development, nursing excellence as a Magnet® designated hospital, and commitment to improve patient outcomes, increasing the number of certified pediatric hematology oncology nurses at Children's Hospital Los Angeles is a priority. Expert certified nurses and educators assessed current staff nurse perceptions of and motivations for becoming certified. A nurse survey was completed, and the results identified barriers to certification and the need for an onsite review course to encourage more nurses to take the Certified Pediatric Hematology Oncology Nurse (CPHON®) exam. The Oncology Nursing Certification Corporation (ONCC) CPHON® test blueprint guided the development of the Children's Hospital Los Angeles review course curriculum. Certified nurse experts volunteered as course instructors to present an overview of pediatric cancer, pediatric hematology, psychosocial review, chemotherapy and related medications, and long-term effects. In addition to course didactics, interactive learning sessions were included to allow participants to question, discuss, and apply new knowledge. Sample test questions were provided to each participant for independent study post-course attendance. Each participant completed course evaluations to measure the usefulness of the content, environment, and teaching methods. Since the implementation of this course, the overall number of certified hematology oncology nurses has increased by 15.3%.

This commentary deals with the need of an early integration between hematologist and palliative care specialists as well as pain therapists as a routine basis in order to ensure the best management of patients affected by acute leukemia from the onset of the disease and in the stages of causal therapy. This strategy could limit the burden of painful symptoms and, in addition, avoid unnecessary suffering to patients, ensuring the best conditions for optimal outcome of these patients with extremely high clinical complexity and symptomatology who receive intensive treatments or who are managed with novel treatment approaches.

Systematic application of observational data to the understanding of impacts of cancer treatments requires detailed information models allowing meaningful comparisons between treatment regimens. Unfortunately, details of systemic therapies are scarce in registries and data warehouses, primarily due to the complex nature of the protocols and a lack of standardization. Since 2011, we have been creating a curated and semi-structured website of chemotherapy regimens, HemOnc.org. In coordination with the Observational Health Data Sciences and Informatics (OHDSI) Oncology Subgroup, we have transformed a substantial subset of this content into the OMOP common data model, with bindings to multiple external vocabularies, e.g., RxNorm and the National Cancer Institute Thesaurus. Currently, there are >73,000 concepts and >177,000 relationships in the full vocabulary. Content related to the definition and composition of chemotherapy regimens has been released within the ATHENA tool (athena.ohdsi.org) for widespread utilization by the OHDSI membership. Here, we describe the rationale, data model, and initial contents of the HemOnc vocabulary along with several use cases for which it may be valuable., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Despite the continuing improvement of automated blood cell counters, confirmation by blood smear examination remains the gold standard in case of anomalies. With a constant goal of standardisation, different experts committees (e.g. the French-speaking cellular hematology group (Groupe francophone d'hématologie cellulaire, GFHC and the ISLH International society for laboratory hematology) recently published criteria for microscopic analysis of blood smears. Cornet et al. evaluated the application of those criteria and propose to suppress any review for 72 hours when a "Blast/Abn lymph" flag is triggered for a sample with no abnormal cell on the microscopic review. The aims of our study were to retrospectively evaluate whether this 72-hour rule adequately operates and whether it is possible to extend the arbitrary 72-hour timeframe to 96h and 144h. To achieve this goal, 40,688 blood samples were collected from three French-speaking hospitals. 1,548 samples presented an isolated "Blast/Abn lymph" flag. Only 221 samples presented the application of the 72-hour rule at least once for our study period. We were able to extend this rule to 144 hours for 10 samples of them. All blood smears for which the rule was applied were verified and there was no abnormal cell on smears at 72 and 144 hours. In conclusion, the 72-hour rule derived from the GFHC's criteria is secure and reduces the slide review rate and thus the production costs and the turnaround time of hemogram results. Further investigations could confirm that its extension to 144 hours is also adequate.

Purpose: In December 2016, 49% of patients admitted to inpatient oncology services at University of Pittsburgh Medical Center Shadyside Hospital had cardiopulmonary resuscitation (CPR) status discussion documentation before discharge. The aim of this project was to improve the rate of CPR status conversations., Methods: During Plan-Do-Study-Act (PDSA) cycle 1, a stakeholder workgroup was formed in January 2017 by oncology faculty, fellows, nurses, advance practice providers (APPs), medicine housestaff, and palliative care faculty. All oncology clinicians and inpatient team members were reminded weekly to discuss and document CPR status preferences. APPs received training on efficient and effective CPR status assessment from palliative care faculty. Oncology leadership received monthly e-mail updates of CPR status documentation rates and endorsed CPR status best practice guidelines. For PDSA cycle 2, patient charts without CPR status documentation in March 2018 were reviewed, and themes were shared with oncology leadership and reviewed with APPs., Results: After PDSA cycle 1, CPR status assessment rates increased from 49% to greater than 80%. In 2017, more than 1,500 more CPR status discussions were documented than in 2016. The percentage of patients discharged with "comfort measures only" or "do not resuscitate" orders increased from 14.2% (95% CI, 9.5% to 19.0%) to 19.8% (95% CI, 15.6% to 24.0%). For PDSA cycle 2, charts of 60 patients without CPR assessment were reviewed. Of these, 52% were admitted overnight by nocturnists and 48% by daytime APPs. Fifty-five percent of patients (n = 33 of 60) had metastatic disease. CPR status was documented on previous admissions for 53% of patients (n = 31 of 60) in the past 12 months. Fifteen percent (n = 11 of 60) were admitted for scheduled inpatient chemotherapy., Conclusion: A multipronged approach significantly increased CPR status assessments. More patients transitioned to comfort measures only or do not resuscitate when their preferences were clearly assessed and documented.

Therapy of hematological malignancies lasts for long periods implicating various complications. The chemotherapy induces fatigue and forces bed rest. These features strongly contribute to a general impairment of the physical efficiency. Oppositely, an increase of physical exercise can prevent or reduce this weakening. Few trials examined the efficacy of an exercise in onco-hematological inpatients, during their hospitalization. Therefore, this study aimed to determine the feasibility of an inter-hospital intervention and the beneficial role of a tailored exercise program in the maintenance of the physical function in onco-hematological inpatients. The study included 42 patients, which were allocated in two groups. In the intervention group (IG) a tailored exercise protocol during patient's hospitalization was administered. Exercise protocol was focused on development of strength, balance control, and flexibility; sessions were directly performed in the patient's hospital room everyday for 15 to 30 minutes. Exercise was supervised by an exercise specialist and driven by a multimedia support. Control group (CG) remained physically inactive for all period of hospitalization. To examine the interaction between the two situations (T 0 and T 1 ) and the two groups (IG and CG) for all dependent variables, a 2 × 2 within-subjects contrasts model analysis of variance was applied. Within groups analysis displayed significant differences in grip and leg strength and in static balance control (P < 0.05) with medium to very large effect size. Results from this investigation showed that a tailored exercise protocol administered to hospitalized onco-hematological patients was feasible and efficient to promote the maintenance of their physical function, improving clinical best practice including exercise to the traditional treatment. Moreover, the magnitude of the difference between the IG and the CG underlined the importance to invite and stimulate patients to workout to preserve the physical function, counteracting side effects of chemotherapy treatments with a concurrent reduction in bed rest syndrome., (© 2019 John Wiley & Sons, Ltd.)

Background and Objectives: The determinants of guideline panels' recommendations remain uncertain. The objective of this study was to investigate factors considered by members of 8 panels convened by the American Society of Hematology (ASH) to develop guidelines using Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system., Study Design and Setting: Web-based survey of the participants in the ASH guidelines panels., Analysis: two-level hierarchical, random-effect, multivariable regression analysis to explore the relation between GRADE and non-GRADE factors and strength of recommendations (SOR)., Results: In the primary analysis, certainty in evidence [OR = 1.83; (95CI% 1.45-2.31)], balance of benefits and harms [OR = 1.49 (95CI% 1.30-1.69)] and variability in patients' values and preferences [OR = 1.47 (95CI% 1.15-1.88)] proved the strongest predictors of SOR. In a secondary analysis, certainty of evidence was associated with a strong recommendation [OR = 3.60 (95% CI 2.16-6.00)] when panel members recommended "for" interventions but not when they made recommendations "against" interventions [OR = 0.98 (95%CI: 0.57-1.8)] consistent with "yes" bias. Agreement between individual members and the group in rating SOR varied (kappa ranged from -0.01 to 0.64)., Conclusion: GRADE's conceptual framework proved, in general, to be highly associated with SOR. Failure of certainty of evidence to be associated with SOR against an intervention, suggest the need for improvements in the process., (Copyright © 2019 Elsevier Inc. All rights reserved.)

The purpose of this quality improvement study was to improve physician documentation of distress in medical records of hematology/oncology veteran patients at the Malcolm Randall Veteran Affairs (VA) Medical Center hematology/oncology fellows' clinic in Gainesville, Florida. Before this intervention, the VA hematology/oncology fellows were not documenting patient distress in medical records. The quality improvement intervention was executed through the use of Plan-Do-Study-Act (PDSA) cycles with an ultimate goal of 50% documentation rate. Physician charts were audited to investigate official documentation of distress in patient charts. Physician documentation of distress was 14% in the first PDSA cycle, 21% in the second PDSA cycle, and 36% in the third PDSA cycle. Additional data on distress in hematology/oncology veteran patients were collected using the National Comprehensive Cancer Network Distress Thermometer and Problem List for Patients. Analysis of findings indicated that 42% of 88 patients experienced distress. Findings also suggest that hematology/oncology veteran patients experience specific sources of distress, notably fatigue and pain. These patients have presumably undergone unique experiences that can result in distress that providers should follow-up with in medical charts. Although this intervention has proven challenging to fully implement, standardizing patient distress in patient medical records has the potential to improve the quality of care provided by hematology/oncology physicians.

Background: The complete blood count (CBC) is a cornerstone of patient care. Several of the normal values for the components of the CBC differ by sex and, therefore, male-specific and female-specific reference intervals are required to interpret these laboratory results. Transgender individuals are often prescribed hormone therapy to affirm their gender, with resulting serum hormone concentrations similar to those of cisgender individuals. Gender-specific reference intervals for transgender men and women have not been established for any laboratory measurements, including hematology. We established clinically relevant hematological reference intervals for transgender individuals receiving stable hormone therapy., Methods: Healthy transgender individuals prescribed testosterone (n = 79) or estrogen (n = 93) for ≥12 months were recruited from internal medicine and primary care clinics that specialize in transgender medical care. Concentrations for hemoglobin, hematocrit, MCV, MCHC, and RDWCV, as well as counts for red cells, white cells, and platelets, were evaluated. Results were interpreted in reference to the overall distribution of values and relative to serum estradiol and total testosterone concentrations. Calculated reference intervals were compared to established cisgender reference intervals., Results: Regardless of serum hormone concentration, individuals prescribed testosterone or estrogen had hematology parameters that were not clinically different from cisgender males and females, respectively., Conclusion: The hematology parameters for transgender men and women receiving stable hormone therapy should be evaluated against the cisgender male and cisgender female reference ranges, respectively and does not require concurrent sex hormone analysis. Care providers can utilize this observation to aid in interpretation of hematology laboratory values for transgender people., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Background and Objectives: Rare but potentially life-threatening hypersensitivity reactions can occur during the administration of intravenous iron. To provide guidance to healthcare professionals caring for adults receiving intravenous iron, a panel of 10 Canadian clinical experts developed a practical algorithm for the identification and management of hypersensitivity reactions to intravenous iron., Materials and Methods: A systematic search of PubMed to February 2018 was performed. Articles related to hypersensitivity reactions were selected for review. The algorithm was developed during a 1-day live meeting based on the literature review and clinical expertise where evidence was lacking. The algorithm was then refined through an iterative process involving a web-based platform and virtual meetings., Results: The algorithm provides guidance to healthcare professionals in preparing for and administering IV iron, as well as recognizing and managing hypersensitivity reactions to intravenous iron. Considerations for re-challenging patients who have experienced prior reactions are provided., Conclusion: Healthcare professionals who are involved in the care of patients receiving intravenous iron should be trained to anticipate, recognize and manage hypersensitivity reactions to intravenous iron to optimize patient care., (© 2019 The Authors. Vox Sanguinis published by John Wiley & Sons Ltd on behalf of International Society of Blood Transfusion.)

Background and Objectives: Paediatric blood transfusion for severe anaemia in hospitals in sub-Saharan Africa remains common. Yet, reports describing the haematological quality of donor blood or storage duration in routine practice are very limited. Both factors are likely to affect transfusion outcomes., Materials and Methods: We undertook three audits examining the distribution of pack types, haematological quality and storage duration of donor blood used in a paediatric clinical trial of blood at four hospitals in Africa (Uganda and Malawi)., Results: The overall distribution of whole blood, packed cells (plasma-reduced by centrifugation) and red cell concentrates (RCC) (plasma-reduced by gravity-dependent sedimentation) used in a randomised trial was 40·7% (N = 1215), 22·4% (N = 669) and 36·8% (N = 1099), respectively. The first audit found similar median haematocrits of 57·0% (50·0,74·0), 64·0% (52·0,72·5; P = 0·238 vs. whole blood) and 56·0% (48·0,67·0; P = 0·462) in whole blood, RCC and packed cells, respectively, which resulted from unclear pack labelling by blood transfusion services (BTS). Re-training of the BTS, hospital blood banks and clinical teams led to, in subsequent audits, significant differences in median haematocrit and haemoglobins across the three pack types and values within expected ranges. Median storage duration time was 12 days (IQR: 6, 19) with 18·2% (537/2964) over 21 days in storage. Initially, 9 (2·8%) packs were issued past the recommended duration of storage, dropping to 0·3% (N = 7) in the third audit post-training., Conclusion: The study highlights the importance of close interactions and education between BTS and clinical services and the importance of haemovigilance to ensure safe transfusion practice., (© 2019 The Authors. Vox Sanguinis published by John Wiley & Sons Ltd on behalf of International Society of Blood Transfusion.)

Background Conventional establishment of reference intervals for hematological analytes is challenging due to the need to recruit healthy persons. Indirect methods address this by deriving reference intervals from clinical laboratory databases which contain large datasets of both physiological and pathological test results. Methods We used the "Reference Limit Estimator" (RLE) to establish reference intervals for common hematology analytes in adults aged 18-60 years. One hundred and ninety-five samples from 44,519 patients, measured on two different devices in a tertiary care center were analyzed. We examined the influence of patient cohorts with an increasing proportion of abnormal test results, compared sample selection strategies, explored inter-device differences, and analyzed the stability of reference intervals in simulated datasets with varying overlap of pathological and physiological test results. Results Reference intervals for hemoglobin, hematocrit, red cell count and platelet count remained stable, even if large numbers of pathological samples were included. Reference intervals for red cell indices, red cell distribution width and leukocyte count were sufficiently stable, if patient cohorts with the highest fraction of pathological samples were excluded. In simulated datasets, estimated reference limits shifted, if the pathological dataset contributed more than 15%-20% of total samples and approximated the physiological distribution. Advanced sample selection techniques did not improve the algorithm's performance. Inter-device differences were small except for red cell distribution width. Conclusions The RLE is well-suited to create reference intervals from clinical laboratory databases even in the challenging setting of a adult tertiary care center. The procedure can be used as a complement for reference interval determination where conventional approaches are limited.

Menometrorrhagia is a frequent bleeding symptom in young women, and may be related to an inherited bleeding disorder. If there is no gynecological etiology, hemostasis tests are required. The early medical management of these teenage girls is important, especially when a bleeding disorder is known. The bleeding risk of the first periods may then be anticipated. Afterwards, the objective of the treatment is to keep the bleeding symptoms under control: anti-fibrinolytic treatment, specific replacement therapy for bleeding disorder and hormonal treatment. This management requires a multidisciplinary medical team, mainly hematologist and gynecologist, all along the genital lifespan, from the first periods to the desire for pregnancy., Competing Interests: A. Harroche déclare des liens ponctuels -interventions et prises en charge lors de congrès- avec Novo Nordisk, Bayer, Pfizer, Shire, Octopharma, LFB, CSL Behring, Sobi et Roche. S. Meunier déclare des liens ponctuels interventions et/ou prise en charge lors de congrès- avec Novo Nordisk, Bayer, Shire, Baxalta/Shire, Octapharma, Pfizer, LFB, CSL-Behring, Sobi et Roche. S. Da Costa déclare n’avoir aucun lien d’intérêts. C. Falaise déclare des liens ponctuels -interventions et/ou prise en charge lors de congrès avec Bayer, Octopharma, Pfizer, Roche, SOBI, Takeda, LFB et Novo Nordisk. C. Oudot déclare des liens -prise en charge lors de congrès avec Shire, Bayer, SOBI, CSL Behring, Octopharma et Novo Nordisk.

Background: Platelet count is known to be associated with sex, age and mean platelet volume (MPV). Sex and age were proposed for adjustment of platelet count reference intervals, but MPV is currently not used for further adjustment. We investigated the association of MPV, age and sex with platelet counts and established individualized reference ranges respecting MPV., Methods: The association of platelet count with age, sex and MPV was assessed in healthy participants (n = 3,033 individuals; 1,542 women) in the cross-sectional population-based cohort Study of Health in Pomerania. Reference intervals respecting age, sex, and MPV were estimated using quantile regressions for the 2.5th and 97.5th percentile., Results: Women had higher platelet counts than men (239 vs. 207 x109/L, p<0.001). Platelet counts correlated with age (p<0.001) and MPV (p<0.001). Quantile regression of lower and upper platelet count limits correlated less with age in female (p = 0.047 for 2.5th percentile; p = 0.906 for 97.5th percentile) and male subjects (p = 0.029 for 2.5th percentile; p = 0.195 for 97.5th percentile) compared to MPV (p<0.001 for upper and lower limit for both sexes). After adjustment for MPV, age did no longer correlate with the 2.5th (p = 0.165) or 97.5th percentile (p = 0.999) of platelet count. In contrast, after adjustment for age, MPV levels still significantly correlated with 2.5th, 50th and 97.5th percentile (p<0.001)., Conclusion: MPV and sex have a stronger association with platelet count than age. MPV should be considered to adjust platelet count reference intervals and needs to be respected as confounder for platelet counts in epidemiological studies and clinical practice., Competing Interests: The authors have declared that no competing interests exist.

Myelodysplastic syndromes (MDS) are clonal diseases defined by clinical, morphologic, and genetic features often shared by related myeloid disorders. The diagnostic boundaries between these diseases can be arbitrary and not necessarily reflective of underlying disease biology or outcomes. In practice, measures that distinguish MDS from related disorders may be difficult to quantify and can vary as disease progression occurs. Patients may harbor findings that are not consistent with a single diagnostic category. Several overlap disorders have been formally described, such as the myelodysplastic/myeloproliferative neoplasms (MDS/MPNs). These disorders are characterized by hematopoietic dysplasia with increased proliferation of monocytes, neutrophils, or platelets. They may have mutational profiles that distinguish them from the disorders they resemble and reflect important differences in pathophysiology. MDS also shares diagnostic borders with other diseases. For example, aplastic anemia and hypoplastic MDS can be difficult to distinguish in patients with pancytopenia and bone marrow hypocellularity. Genetic features may help in this regard, because they can identify differences in prognosis and risk of progression. The boundary between MDS and secondary acute myeloid leukemia (sAML) is arbitrarily defined and has been redefined over the years. Genetic studies have demonstrated that sAML clones can precede clinical progression from MDS by many months, suggesting that MDS with excess blasts could be viewed as an overlap between a dysplastic bone marrow failure syndrome and an oligoblastic leukemia. This review will describe the diagnostic boundaries between MDS, MDS/MPNs, sAML, clonal hematopoiesis of indeterminate potential, clonal cytopenia of undetermined significance, and aplastic anemia and how genetic approaches may help to better define them., (© 2019 by The American Society of Hematology.)

The heterogeneous nature of myelodysplastic syndromes (MDS) demands a complex and personalized variety of therapeutic approaches. Among them, allogeneic hematopoietic stem cell transplantation remains the only potentially curative option and is accessible to only a small number of fit patients. For the majority of patients with MDS, treatment strategies are nonintensive and risk-adapted (by the revised version of the International Prognostic Scoring System), ranging from iron chelation and growth factors to lenalidomide and hypomethylating agents. These approaches are noncurative and aimed instead at improving cytopenias and quality of life and delaying disease progression. These limitations underpin the need for more translational research-based clinical trials in well-defined subgroups of patients with MDS. Indeed, much progress has been made over the past decade in understanding the complex molecular mechanisms underlying MDS. Unfortunately, this has not yet translated into approval of novel treatment options. There is a particularly urgent medical need in patients failing current first-line therapies, such as with erythropoiesis-stimulating or hypomethylating agents. Nevertheless, actual developments are expected to pave the way for exciting novel therapeutic opportunities. This review provides an overview of the current therapeutic landscape in MDS focusing on recent advances in clinical and translational research., (© 2019 by The American Society of Hematology.)

The heterogeneity of myelodysplastic syndromes (MDSs) has made evaluating patient response to treatment challenging. In 2006, the International Working Group (IWG) proposed a revision to previously published standardized response criteria (IWG 2000) for uniformly evaluating clinical responses in MDSs. These IWG 2006 criteria have been used prospectively in many clinical trials in MDSs, but proved challenging in several of them, especially for the evaluation of erythroid response. In this report, we provide rationale for modifications (IWG 2018) of these recommendations, mainly for "hematological improvement" criteria used for lower-risk MDSs, based on recent practical and reported experience in clinical trials. Most suggestions relate to erythroid response assessment, which are refined in an overall more stringent manner. Two major proposed changes are the differentiation between "procedures" and "criteria" for hematologic improvement-erythroid assessment and a new categorization of transfusion-burden subgroups., (© 2019 by The American Society of Hematology.)

Background: Many laboratory tests are reported and interpreted with sex-specific reference intervals. However, transgender individuals receiving masculinizing or feminizing hormone therapy experience physiological changes predisposing some laboratory tests to shift outside of existing reference intervals. In this study, we review laboratory testing of a large cohort of transgender individuals who were prescribed hormone therapy for at least 6 months at an academic medical center., Methods: Transgender patients were identified using a search function within the electronic health record with gender identity status verified by chart review. Patients were grouped based on type of hormone therapy administered. All laboratory studies were ordered for medical purposes as part of clinical care; as a result, the exact laboratory tests differed among the patients. Some of the patients had sufficient data for both 6- and 12-month comparisons with baseline laboratory values., Results: Statistically significant changes were observed at 6- and 12-month comparisons in basic chemistry, endocrine, and hematologic parameters for transgender individuals receiving masculinizing or feminizing hormones. Chart review demonstrated variation in route of administration of hormone therapy and frequency of gender-affirming surgery within the study population., Conclusions: Transgender individuals receiving hormone therapy experienced significant changes in components of basic chemistry, endocrine, and hematologic parameters following administration of hormone therapy. Variability in hormone dosing and route of administration for gender-affirming treatment warrants further investigation., (© 2018 American Association for Clinical Chemistry.)

Laboratory results interpretation for diagnostic accuracy and clinical decision-making in this period of evidence-based medicine requires cut-off values or reference ranges that are reflective of the geographical area where the individual resides. Several studies have shown significant differences between and within populations, emphasizing the need for population-specific reference ranges. This cross-sectional experimental study sought to establish the haematological reference values in apparently healthy individuals in three regions in Ghana. Study sites included Nkenkaasu, Winneba, and Nadowli in the Ashanti, Central, and Upper West regions of Ghana, respectively. A total of 488 healthy participants were recruited using the Clinical and Laboratory Standards Institute (United States National Consensus Committee on Laboratory Standards, NCCLS) Guidance Document C28A2. Medians for haematological parameters were calculated and reference values determined at 2.5 th and 97.5 th percentiles and compared with Caucasian values adopted by our laboratory as reference ranges and values from other African and Western countries. RBC count, haemoglobin, and haematocrit (HCT) were significantly higher in males compared to females. There were significant intraregional and interregional as well as international variations of haematological reference ranges in the populations studied. We conclude that, for each geographical area, there is a need to establish geography-specific reference ranges if accurate diagnosis and concise clinical decisions are to be made.

Introduction: Effective medical laboratory quality management systems ensure confidence in analyzing and reporting accurate and reliable patient results. To guarantee quality assurance, each laboratory needs appropriate internal quality control (IQC) procedures to monitor their test systems. The Institute for Quality Management in Healthcare (IQMH) Centre for Proficiency Testing conducted a survey on quality control (QC) practices in routine hematology., Methods: An online survey was sent to 184 Ontario laboratories performing complete blood counts (CBC) and leukocyte differentials., Results: All participants used three levels of commercial QC for test system monitoring. Eighty percent of laboratories supplement with in-house patient QC. The frequency of QC analysis was variable based on: Manufacturer recommendations (80%) Parameter stability (25%) Clinical impact of incorrect results (21%) Number of samples potentially requiring retesting if there is a QC failure (11%). All laboratories used established QC rules and limits to monitor results. They utilized various methods in establishing limits including: Standard deviation of QC results (60%) Manufacturer precision goals (55%) Published precision goals (24%) IQMH allowable performance limits (APLs) (37%)., Conclusion: Considerable variation in QC practices of Ontario laboratories was identified, and consensus practice recommendations and precision goals were developed to guide and standardize QC practice., (© 2018 John Wiley & Sons Ltd.)

Purpose: The College of American Pathologists (CAP) and the American Society of Hematology (ASH) developed an evidence-based guideline on the initial diagnostic work-up of acute leukemia (AL). Because of the relevance of this topic to the ASCO membership, ASCO reviewed the guideline and applied a set of procedures and policies for endorsing clinical practice guidelines that have been developed by other professional organizations., Methods: The CAP-ASH guideline on initial diagnostic work-up of AL was reviewed for developmental rigor by methodologists. Then, an ASCO Endorsement Expert Panel updated the literature search and reviewed the content and recommendations., Results: The ASCO Expert Panel determined that the recommendations from the guideline, published in 2016, are clear, thorough, and based on the most relevant scientific evidence. ASCO fully endorsed the CAP-ASH guideline on initial diagnostic work-up of AL and included some discussion points according to clinical practice and updated literature., Conclusion: Twenty-seven guideline statements were reviewed. Some discussion points were included to better assess CNS involvement in leukemia and to provide novel insights into molecular diagnosis and potential markers for risk stratification and target therapy. These discussions are categorized into four sections: (1) initial diagnosis focusing on basic diagnostics and determination of risk parameters, (2) molecular markers and minimal residual disease detection, (3) context of referral to another institution with expertise in the management of AL, and (4) reporting and record keeping for better outlining and follow-up discussion. Additional information is available at: www.asco.org/hematologic-malignancies-guidelines .