Clinical Hematology Laboratory Research Articles

B-047 Performance Evaluation of Enzymatic HbA1c Assay on Newly Launched Mindray BS-600M Chemistry Analyzer

Abstract Background HbA1c has important reference value in risk stratification, diagnosis, therapeutic monitoring and drug selection for diabetic patients. Therefore, the ability to detect HbA1c has attracted much attention. This study was designed to evaluate the performance of the enzymatic HbA1c assay on a newly launched Mindray BS-600M chemistry analyzer, which can be used to measure whole blood samples directly after mixing without centrifugation. Methods Total 309 clinical samples (EDTA anticoagulation) were analyzed using Mindray BS-600M (enzymatic method), Tosoh G8 (HPLC method) and Roche c501 (immunoassay method) analyzers for the performance comparison. And also, the analytical performance of BS-600M, such as precision, accuracy, linearity, interference of conventional interferents, hemoglobin variants, hemoglobin derivatives and common drugs, were evaluated using other fresh whole blood samples, eight frozen calibrators (IFCC) and forty frozen venous whole blood samples (NGSP). Results The within-run and between-run precision of the enzymatic method for HbA1c determination were less than 1% and linearity of HbA1c (%, NGSP unit) was excellent from 2.96% to 20.23%. The deviations between the results of 48 accuracy samples (IFCC and NGSP) and target values were within ±5%, and the sigma metrics of HbA1c at the high and low concentration levels were between 9.9∼19.0, which belongs to the "world-class" level. The results were excellently correlated with those obtained by Tosoh HLC -723 G8 and Roche Cobas c501 (r = 0.997, 0.992). The regression equations of HbA1c was y = 0.979x + 0.005 (n = 198) between BS-600M and G8 and y = 0.934x + 0.317 (n = 112) between BS-600M and c501. The deviation of interference from conventional interferents (bilirubin, Intralipid, vitamin C), hemoglobin variants (HbS, HbC, HbD, HbE), hemoglobin derivatives (LAlc, CarHb, AcetylatedHb), and commonly used antipyretic analgesics and hypoglycemic drugs were all within ±6%, except for the high level HbF (>10%); and also, BS-600M cannot be applied to severe anemia patients (HGB < 45 g/L), which may lead to falsely high HbA1c results. Conclusion The Mindray BS-600M proved to be a robust and reliable method for HbA1c measurement, and was suitable for routine clinical chemistry or hematology laboratory use. In addition, attention or comment need to be added for samples having high HbF concentrations and severe anemia patients in reporting HbA1c% result.

The role of molecular diagnostic testing for hemoglobinopathies and thalassemias.

Hemoglobin disorders are among the most common genetic diseases worldwide. Molecular diagnosis is helpful in cases where the diagnosis is uncertain and for genetic counseling. Protein-based diagnostic techniques are frequently adequate for initial diagnosis. Molecular genetic testing is pursued in some cases, particularly when a definitive diagnosis is not possible and especially for the purpose of assessing genetic risk for couples wanting to have children. The expertise available in the clinical hematology laboratory is essential for the diagnosis of patients with hemoglobin abnormalities. Initial diagnoses are made using protein-based techniques such as electrophoresis and chromatography. Based on these findings, genetic risk to an individual's offspring can be assessed. In the setting of β-thalassemia and other β-globin disorders, coincident α-thalassemia may be difficult to diagnose, which can have potentially serious consequences. In addition, unusual forms of β-thalassemia caused by deletions in the β-globin locus cannot be definitively characterized using standard techniques. Molecular diagnostic testing has an important role in the diagnosis of hemoglobin disorders and is important in the setting of genetic counseling. Molecular testing also has a role in prenatal diagnosis to identify fetuses affected by severe hemoglobinopathies and thalassemias.

An Overview of Complete Blood Count Sample Rejection Rates in a Clinical Hematology Laboratory Due to Various Preanalytical Errors.

Introduction The Chughtai Laboratory collects blood samples for complete blood counts from various hospitals, emergency departments, ICUs, and through home sampling servicesall across the country. The preanalytical phase isan integral componentof laboratory medicine. A laboratory report has a key role in patient treatment and the clinician's decision in the management of the disease. Preanalytical errors are most frequently caused by the absence of a sample and/or inappropriate understanding of a test request, mislabeling, contamination from the sampling site, hemolyzed, clotted, insufficient samples, storage issues, and inappropriate blood to anticoagulant proportion or inappropriate choice of anticoagulant. Objective To identify the cause ofrejection rates ofthe complete blood countsamples and reduce the rejection rates by improving the accuracy of the results and loweringpre-analytical errors. Methods This cross-sectional study was done in the Hematology Department of Chughtai Laboratory's head office in Lahore between 19-06-2021 and 19-10-2021. Simple random sampling was applied to collect the data. About 3 ml of each blood sample was received in an ethylenediaminetetraacetic acid (EDTA) vial, inspected visually, run on Sysmex XN-9000 (Sysmex Corporation,Kobe, Hyogo, Japan), and was reviewed on peripheral smears. Results Out of 231,008 blood samples, 11,897 (5.15%) samples were rejected. The most common pre-analytical mistake was storage issues due to transportation delay (19.45%) followed by wrong medical records (19.16%), diluted samples (16.35%), incorrect tubes (16.01%), hemolyzed samples (15.13%), unlabeled samples (10.01%), and clotted sample (3.88%). Conclusion In the hematology department, the total rejection rate observed during the study period was 5.15%. Recognition of preanalytical errors and avoiding them will help uslower the sample rejection rateand raise the overall quality of laboratory management.

Problems and Reform Suggestions in Clinical Hematology Laboratory Teaching

Problems and Reform Suggestions in Clinical Hematology Laboratory Teaching

Hematologic indices in individuals with pathogenic germline DICER1 variants.

Pathogenic germline variants in DICER1 underlie an autosomal dominant, pleiotropic tumor-predisposition disorder. Murine models with the loss of DICER1 in hematopoietic stem cell progenitors demonstrate hematologic aberrations that include reductions in red and white blood cell counts, hemoglobin volume, and impaired maturation resulting in dysplasia. We investigated whether hematologic abnormalities such as those observed in DICER1-deficient mice were observed in humans with a pathogenic germline variant in DICER1. A natural history study of individuals with germline pathogenic DICER1 variants and family controls conducted through the National Cancer Institute (NCI) evaluated enrollees at the National Institutes of Health Clinical Center during a comprehensive clinical outpatient visit that included collecting routine clinical laboratory studies. These were compared against normative laboratory values and compared between the DICER1 carriers and controls. There were no statistical differences in routine clinical hematology laboratory studies observed in DICER1 carriers and family controls. A review of the medical history of DICER1 carriers showed that none of the individuals in the NCI cohort developed myelodysplastic syndrome or leukemia. Query of the International Pleuropulmonary Blastoma/DICER1 Registry revealed 1 DICER1 carrier who developed a secondary leukemia after treatment of pleuropulmonary blastoma. We found limited evidence that the hematologic abnormalities observed in murine DICER1 models developed in our cohort of DICER1 carriers. In addition, no cases of myelodysplastic syndrome were observed in either the NCI cohort or the International Pleuropulmonary Blastoma/DICER1 Registry; 1 case of presumed secondary leukemia was reported. Abnormalities in hematologic indices should not be solely attributed to DICER1. This trial was registered at www.clinicaltrials.gov as #NCT01247597.

Atypical Peripheral Blood Cell Morphology in COVID-19 (Sars-CoV-2) Patients from Mount Sinai Health System in New York City

INTRODUCTIONCoronavirus disease 2019 (COVID-19) is a respiratory disease caused by a novel coronavirus named severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2). Recent studies have suggested that COVID-19 positive patients present with leukopenia, lymphopenia, neutrophilia, thrombocytopenia, and higher neutrophil: lymphocyte ratio (NLR) and monocyte: lymphocyte ratio (MLR). More recently, we reported hypersegmented granulocytes and COVID-19 infection in Blood. 2020 Jun 11;135(24):2196. Neutrophil hypersegmentation has been closely associated with vitamin B12, folate and iron deficiencies, as well as methotrexate use, chemotherapy toxicity, uremia, heat stroke, myelodysplasia and Boucher-Neuhäuser Syndrome. Initially, these cytomorphologic changes may easily be overlooked or dismissed as non-specific reactive changes. In this study, we expand our initial observation on our index case to a larger case series. To the best of our knowledge, this is the largest case series to describe the concurrent lymphocyte and unique granulocyte atypia associated with SARS-CoV-2 infection.METHODSStudy Design2,199 patients were hospitalized in the Mount Sinai Health System from Feb 27 to April 2, 2020 with confirmed COVID-19 positivity. Data obtained for this study was covered under an Institutional Review Board (IRB) waiver, HS#:12-00133 GCO#1:12-036(0001-08)Inclusion criteria50 peripheral blood smears flagged for Pathologist review from March 13 - April 20, 2020 at Mount Sinai Hospital Clinical Hematology Laboratory were included in this study. All suspected COVID-19 cases were confirmed using real-time polymerase chain reaction (RT-PCR) assay to test nasal and pharyngeal swab specimens, per WHO guidelines.Of the 50 COVID-19 positive peripheral blood smears, 39 slides were scanned and imaged with Scopio Labs X100 Full Field Digital Microscope. The X100 provided high resolution oil-immersion level images of large scanned areas. https://scopiolabs.com/hematology/19 peripheral blood smears were blindly and independently reviewed by 4 Hematopathologists (CS, PK, JC, JTF), with particular emphasis on granulocyte cytomorphology and percent of hypersegmented neutrophils present (defined as neutrophils with 5 or more nuclear lobes in at least 3% of cells or presence of 6 or more lobes). Atypical lymphocyte morphology was also evaluated and categorized as Downey type I, II, III or plasmacytoid, while monocyte morphology was assessed for unusual nuclear folds and features. Evaluation of platelets and other abnormalities were noted. The presence and degree of significant cytologic atypia was recorded and compared to 20 COVID-19 negative blood smears.RESULTS16 of the 19 (84%) COVID-19 positive cases showed hypersegmented neutrophils, and all 19 harbored atypical lymphocytes and monocyte morphology, with giant platelets. In contrast, 5 of the 20 (25%) COVID-19 negative cases showed hypersegmented neutrophils, with 2 patients displaying atypical monocytes; none showed atypical lymphocytes or giant platelets (p = 0.022). Concurrent laboratory values showed no evidence of vitamin B12 or folate deficiency. Representative images are summarized in Figure 1 (A-C, 5-6 lobed neutrophils; D-E atypical plasmacytoid lymphocytes, G-I atypical monocytes, J-L giant platelets).CONCLUSIONWe report atypical hypersegmented neutrophils with toxic cytoplasmic change, atypical monocytes, plasmacytoid lymphocytes, and giant platelets in peripheral blood smears of COVID-19 patients which are significantly higher than in control COVID-19 negative patients.Figure 1DisclosuresTeruya-Feldstein:Edge Anthem: Consultancy.

Management of Diffuse Necrotic Cutaneous Wound in a Dog

A one-year-old male Terrier dog weighing 22 kg was presented to the Ahmadu Bello University Veterinary Teaching Hospital (ABUVTH), Zaria, Nigeria, with complaints of sloughing of the skin and purulent discharges from an injured (sloughed) shoulder. Clinical examination revealed normal vital parameters, extensive necrotized skin on the dorsum extending from loin to the right shoulder and enlarged superficial lymph nodes. Blood and wound swab samples were evaluated in the clinical haematology and Microbiology Laboratories of the ABUVTH, respectively. The Pathology result showed leucocytosis due to neutrophilia and monocytosis. Staphylococcus aureus was isolated from the wound swab. The wound was managed by wet-to-dry bandaging technique using topical antiseptics (Para-chloroaniline solution, chlorhexidine and povidone iodine), improvised non-adhesive protective membrane (polyethylene) applied at the wound-bandage interface, bandages along with adhesive tape and systemic antibiotics. Healing occurred uneventfully within 6 weeks of the intervention. The paper discusses the detail of the management initiated and how it greatly influenced the skin wound healing in dogs. In conclusion, proper initial assessment of wounds and appropriate treatment through rigorous wound assessment and bandaging are critical to success in the wound healing and restoration of tissue integrity. This management intervention could be further investigated in animals in order to improve the quality of cutaneous wounds management.

COVID-19 and the clinical hematology laboratory.

The ongoing COVID‐19 pandemic originated in Wuhan, Hubei Province, China, in December 2019. The etiologic agent is a novel coronavirus of presumed zoonotic origin with structural similarity to the viruses responsible for severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). Like SARS and MERS, COVID‐19 infection manifests most frequently with lower respiratory symptoms. A minority of patients progress to acute respiratory distress syndrome/ diffuse alveolar damage. In addition to its central role in the diagnosis of COVID‐19 infection, the clinical laboratory provides critical information to clinicians regarding prognosis, disease course, and response to therapy. The purpose of this review is to (a) provide background context about the origins and course of the pandemic, (b) discuss the laboratory's role in the diagnosis of COVID‐19 infection, (c) summarize the current state of biomarker analysis in COVID‐19 infection, with an emphasis on markers derived from the hematology laboratory, (d) comment on the impact of COVID‐19 on hematology laboratory safety, and (e) describe the impact the pandemic has had on organized national and international educational activities worldwide.

Finish before the start: Analyzing preanalytical sample errors in a tertiary care hematology laboratory

(a) To evaluate the types and frequencies of preanalytical errors occurring in a tertiary care hematology diagnostic center and (b) To evaluate differences if any, across groups [outpatient data (OPD) vs inpatient data (IPD), type of test requested [complete blood count (CBC) vs coagulation] and laboratory (routine vs emergency). A prospective study was conducted over a period of nine months (August 2017-April 2018) to address the above objectives. All samples received in the clinical hematology division of our institute were included in the analysis. Categories of preanalytical errors were defined. This included insufficient, clotted, diluted, and lipemic samples. Clerical errors such as wrong/absent sample labeling, requisition form-sample mismatch, and wrong vacutainer selection were also documented. IPD and OPD data, as well as data pertaining to samples sent for different tests [complete blood count (CBC)/coagulation] and in the routine and emergency laboratories, were segregated. All errors in each category were recorded as numbers and corresponding percentages (proportions). The two-tailed z-test was applied to assess the significance of the difference in proportions across all groups. Statistical significance was kept at P < 0.05. A total of 189,104 samples were received in the clinical hematology laboratory during the aforementioned period, out of which preanalytical errors were found in 4052 (2.14%) samples. Inadequate sample quantity (ISQ) comprised the bulk of preanalytical errors in our laboratory (1.11% of total samples) followed by sample clots (0.88%). There was no significant difference in the error frequencies in OPD and IPD (P = 0.1031). The proportion of errors was higher in routine vis-à -vis emergency samples and also in samples sent for coagulation analysis vis-à -vis CBC.

A COVID-19 and the clinical hematology laboratory: review

A COVID-19 and the clinical hematology laboratory: review

Preanalytical issues identification and prevention in clinical hematology laboratory: best practice for patient safety

Introduction: Pre-analytical variable includes sample collection, transport, handling, physiological influences and/or interference factors. As the blood collection is the first step, any error in this step will endanger the whole test results, no matter how accurately these are analyzed in the laboratory. Material and Method: In present prospective study, some common issues in blood collection and handling in hospital inpatient and outdoor patient departments of Dhiraj General Hospital (tertiary health care center in Vadodara) have been discussed by giving some expected solutions. Pre-analytics involve the patient, the physician, the resident doctor, the nursing staff, the laboratory technician, the laboratory personnel and the transport service. Result: A total of 13178 received samples, the number of preanalytical issues documented were 185 in OPD and 388 in IPD. Conclusion: All the staff is required to know about preanalytical variables, their possible sources and their effect on the test results and ultimate outcome on patient’s safety. Moreover, since the resident doctors have a direct interaction with the paramedical staff, it is very important for them to understand the preanalytical variables so that they could instruct the paramedical staff accordingly.

Evaluation of Quality Control in Clinical Chemistry and Hematology Using Sigma Metrics

Abstract Objectives The aim of this study was to evaluate clinical chemistry and hematology laboratory performance using six sigma metrics. Methods Clinical chemistry data and hematology data were analyzed from Bungoma Referral Hospital. Five parameters from renal and liver function tests were studied over a period of 6 months (December 2016 to May 2017). Data from IQC and EQA participation were used. The analytes were plasma creatinine, aspartate transaminase (AST), alanine transaminase (ALT), total serum protein, and total and direct bilirubin. Hematology parameters, namely white blood cell count (WBC), red blood cell count (RBC), and hemoglobin (Hb) levels, were studied. Data from IQC and EQA participation were used. Sigma metrics was calculated using total allowable error as per CLIA recommendations. Bias was calculated from HUQAS EQA participation while coefficient of variation was calculated from IQC data collected during the abovementioned months. Results Clinical chemistry had sigma metrics below 3; the highest sigma value was 2.01 while the lowest sigma value was 0.85. Hematological parameters had sigma levels above 3. The highest sigma value was 7.21 while the lowest sigma value was 3.87. Only one level of sigma was below 4. Conclusion Clinical chemistry analytes had sigma levels less than 3; method performance improvement with stringent internal quality control and correct setting of control limits need to be applied. Application of sigma metrics in addition to daily internal quality control can identify analytical deficits and improvement in clinical laboratories. Most hematological parameters had sigma levels above 3. The highest sigma value was 7.21 while the lowest sigma value was 3.87. Only one level of sigma was below 4.

Study of biodistribution and systemic toxicity of glucose functionalized SPIO/DOX micelles

The present study examined the cytotoxicity and magnetic resonance imaging (MRI) distribution of cancer-targeted, MRI-visible polymeric micelles that encapsulate doxorubicin (DOX) and superparamagnetic iron oxide (SPIO) and are conjugated with glucose as a targeting ligand. In this study, the micelles were investigated the clinical potential of glucose-micelles, in vitro cytotoxicity assays of nonencapsulating or SPIO-and-DOX-coencapsulating micelles were performed on L929 mouse fibroblasts, and we found that glucose-micelles did not exert in vitro cytotoxic effects. Next, in vitro MRI detectability of glucose SPIO micelles was evaluated at the loaded SPIO content of 2.5% and 50%, and it was found that glucose-micelles can increase MRI relaxivity (r2*) at high SPIO loading. Furthermore, 50% SPIO micelles persisted in the blood circulation for up to 5 days (slow liver clearance) as determined by in vivo MRI. For in vivo toxicity evaluation, 50% SPIO/DOX micelles at a dose up to 18 (mg DOX)/(kg body weight) showed no impact on animal health according to clinical chemistry and clinical hematology laboratory testing. Altogether, these results indicate that glucose-micelles can serve as an effective and safe drug delivery system.

Comparison of Different Small Clinical Hematology Laboratory Configurations With Focus on Remote Smear Imaging.

Stand-alone clinical sites (eg, infusion centers) are becoming increasingly common. These sites require timely hematology analysis. Here we compare performance and costs of currently available analysis configurations with special focus on a proposed alternative using a minimal hematology analyzer plus a digital imaging device, allowing for remote oversight and interpretation. To determine whether low-volume laboratories might realize savings while gaining function by substituting commonly used configurations with a proposed alternative. To evaluate the performance of the proposed alternative configuration, blood counts with automated differentials produced by a Sysmex XE5000 (complete blood count reference method) were compared with cell counts from the Sysmex pocH-100i, CellaVision DM96 preclassified differentials, and DM96 reclassified differentials (differential reference method) by using standard regression analyses, 95% CIs, and truth tables. Financial cost modeling used staffing practices, test volumes, and smear production rates observed at remote clinics performing on-site hematology analysis within the University of California at San Diego Health system. Differential blood count parameters showed excellent correlation between the XE5000 and preclassification DM96 with R2 > 0.95. For blasts/abnormal cells, immature granulocytes, and nucleated red blood cells, the DM96 showed higher sensitivity and similar specificity to the XE5000. Cost modeling revealed that decreased personnel costs through remote monitoring of results facilitated by the DM96 would lead to lower operational costs relative to more conventional analysis configurations. A digital imaging instrument with an inexpensive hematology analyzer provides similar information to a complex hematology analyzer and allows remote review of the blood smear findings by experts, leading to significant cost savings.

Indirect methods for reference interval determination - review and recommendations.

Reference intervals are a vital part of the information supplied by clinical laboratories to support interpretation of numerical pathology results such as are produced in clinical chemistry and hematology laboratories. The traditional method for establishing reference intervals, known as the direct approach, is based on collecting samples from members of a preselected reference population, making the measurements and then determining the intervals. An alternative approach is to perform analysis of results generated as part of routine pathology testing and using appropriate statistical techniques to determine reference intervals. This is known as the indirect approach. This paper from a working group of the International Federation of Clinical Chemistry (IFCC) Committee on Reference Intervals and Decision Limits (C-RIDL) aims to summarize current thinking on indirect approaches to reference intervals. The indirect approach has some major potential advantages compared with direct methods. The processes are faster, cheaper and do not involve patient inconvenience, discomfort or the risks associated with generating new patient health information. Indirect methods also use the same preanalytical and analytical techniques used for patient management and can provide very large numbers for assessment. Limitations to the indirect methods include possible effects of diseased subpopulations on the derived interval. The IFCC C-RIDL aims to encourage the use of indirect methods to establish and verify reference intervals, to promote publication of such intervals with clear explanation of the process used and also to support the development of improved statistical techniques for these studies.

Development of red blood cell autoantibodies following treatment with checkpoint inhibitors: a new class of anti-neoplastic, immunotherapeutic agents associated with immune dysregulation

Ipilimumab, nivolumab, and pembrolizumab represent a new class of immunotherapeutic drugs for treating patients with advanced cancer. Known as checkpoint inhibitors, these drugs act to upregulate the cellular and humoral immune response to tumor antigens by inhibiting T-cell autoregulation. As a consequence, they can be associated with immune-related adverse events (irAEs) due to loss of self-tolerance, including rare cases of immune-related cytopenias. We performed a retrospective clinical chart review, including serologic, hematology, and chemistry laboratory results, of two patients who developed red blood cell (RBC) autoantibodies during treatment with a checkpoint inhibitor. Serologic testing of blood samples from these patients during induction therapy with ipilimumab and nivolumab, respectively, showed their RBCs to be positive by the direct antiglobulin test (IgG+, C3+) and their plasma to contain panreactive RBC autoantibodies. Neither patient had evidence of hemolysis. Both patients developed an additional irAE during treatment. A literature review for patients who had developed immune-mediated cytopenia following treatment with a checkpoint inhibitor was performed. Nine other patients were reported with a hematologic irAE, including six with anemia attributable to autoimmune anemia, aplastic anemia, or pure RBC aplasia. Hematologic irAEs tend to occur early during induction therapy, often coincident with irAEs of other organs. In conclusion, checkpoint inhibitors can be associated with the development of autoantibodies, immune-mediated cytopenias, pure RBC aplasia, and aplastic anemia. Immunohematology reference laboratories should be aware of these agents when evaluating patients with advanced cancer and new-onset autoantibodies, anemia, and other cytopenias.

Reform and practice of comprehensive experimental teaching in clinical hematology laboratory course

To train the talents of clinical laboratory for the demand of clinical jobs, it is necessary to make the experimental teaching reform of clinical laboratory hematology. Comprehensive experimental teaching, which centers on case, has been explored in many ways like prefessional teachers' training, cases' choose, teaching method and experimental examination. And the practice has proved that the reform of comprehensive experimental teaching can give full play to the students' initiative and creativity, foster the students' ability to analyze and diagnose hematopathy. Key words: Clinical hematology laboratory course; Comprehensive experiment; Teaching reform

Report on the International Society for Laboratory Hematology Survey on guidelines to support clinical hematology laboratory practice.

Given the importance of evidence-based guidelines in health care, we surveyed the laboratory hematology community to determine their opinions on guideline development and their experience and interest in developing clinical hematology laboratory practice guidelines. The study was conducted using an online survey, distributed to members of the International Society for Laboratory Hematology (ISLH) in 2015, with analysis of collected, anonymized responses. A total of 245 individuals participated. Most worked in clinical and/or research laboratories (83%) or industry (11%). 42% felt there were gaps in current guidelines. The majority (58%) recommended that ISLH engages its membership in guideline development. Participants differed in their familiarity with, and use of, different organizations' guidelines. Participants felt it was important to follow best practice recommendations on guideline development, including engagement of experts, statement about conflict of interests and how they were managed, systematic review and grading evidence for recommendations, identifying recommendations lacking evidence or consensus, and public input and peer review of the guideline. Moreover, it was considered important to provide guidelines free of charge. Industry involvement in guidelines was considered less important. The clinical laboratory hematology community has high expectations of laboratory practice guidelines that are consistent with recent recommendations on evidence-based guideline development.

The revenue generated from clinical chemistry and hematology laboratory services as determined using activity-based costing (ABC) model.

Background The rapid and continuous growth of health care cost aggravates the frequently low priority and less attention given in financing laboratory services. The poorest countries have the highest out-of-pocket spending as a percentage of income. Higher charges might provide a greater potential for revenue. If fees raise quality sufficiently, it can enhance usage. Therefore, estimating the revenue generated from laboratory services could help in capacity building and improved quality service provision.Methods Panel study design was used to determine revenue generated from clinical chemistry and hematology services at Tikur Anbessa Specialized Teaching Hospital, Addis Ababa, Ethiopia. Activity-Based Costing (ABC) model was used to determine the true cost of tests performed from October 2011 to December 2011 in the hospital. The principle of Activity-based Costing is that activities consume resources and activities consumed by services which incur the costs and hence service takes the cost of resources. All resources with costs are aggregated with the established casual relationships. The process maps designed was restructured in consultation with the senior staffs working and/or supervising the laboratory and pretested checklists were used for observation. Moreover, office documents, receipts and service bills were used while collecting data. The amount of revenue collected from services was compared with the cost of each subsequent test and the profitability or return on investment (ROI) of services was calculated. Data were collected, entered, cleaned, and analyzed using Microsoft Excel 2007 software program and Statistical Software Package for Social Sciences version 19 (SPSS). Paired sample t test was used to compare the price and cost of each test. P-value less than 0.05 were considered as statistically significant.ResultA total of 25,654 specimens were analyzed during 3 months of regular working hours. The total numbers of clinical chemistry and hematology tests performed during the study period were 45,959 (66.1 %) and 23,570 (33.9 %), respectively. Only 274, 386 (25.3 %) Ethiopian Birr (ETB) was recovered from the total cost of 1,086,008.09 ETB incurred on clinical chemistry and hematology laboratory tests. The result showed that, about 133,821 (12.32 %) ETB was revenue not collected from out-of-pocket payments that was paid for the services as a result of under pricing. The result showed that 18 out of 20 laboratory tests were under priced. The cost burden related to free Anti Retro-viral Therapy (ART) services was 285,979.82 (26.3 %) ETB.ConclusionThe cost per test estimated was significantly different to the existing price. About 90 % of the tests were under priced. This information could warn the hospital to reconsider resetting prices of these tests profitability ration less than 1. The revenue collected could help to build capacity, upscale quality, and sustainable service delivery.

Cp-R, an interface the R programming language for clinical laboratory method comparisons

Background and objectiveClinical scientists frequently need to compare two different bioanalytical methods as part of assay validation/monitoring. As a matter necessity, regression methods for quantitative comparison in clinical chemistry, hematology and other clinical laboratory disciplines must allow for error in both the x and y variables. Traditionally the methods popularized by 1) Deming and 2) Passing and Bablok have been recommended. While commercial tools exist, no simple open source tool is available. The purpose of this work was to develop and entirely open-source GUI-driven program for bioanalytical method comparisons capable of performing these regression methods and able to produce highly customized graphical output. MethodsThe GUI is written in python and PyQt4 with R scripts performing regression and graphical functions. The program can be run from source code or as a pre-compiled binary executable. The software performs three forms of regression and offers weighting where applicable. Confidence bands of the regression are calculated using bootstrapping for Deming and Passing Bablok methods. Users can customize regression plots according to the tools available in R and can produced output in any of: jpg, png, tiff, bmp at any desired resolution or ps and pdf vector formats. Bland Altman plots and some regression diagnostic plots are also generated. Correctness of regression parameter estimates was confirmed against existing R packages. ResultsThe program allows for rapid and highly customizable graphical output capable of conforming to the publication requirements of any clinical chemistry journal. Quick method comparisons can also be performed and cut and paste into spreadsheet or word processing applications. ConclusionsWe present a simple and intuitive open source tool for quantitative method comparison in a clinical laboratory environment.