Standardization of haematology critical results management in adults: an International Council for Standardization in Haematology, ICSH, survey and recommendations.

INTRODUCTION: These recommendations are intended to develop a consensus in the previously published papers as to which parameters and what values should be considered critical. A practical guide on the standardization of critical results management in haematology laboratories would be beneficial as part of good laboratory and clinical practice and for use by laboratory-accrediting agencies. METHODS: A working group with members from Europe, America, Australasia and Asia was formed by International Council for Standardization in Haematology. A pattern of practice survey of 21 questions was distributed in 2014, and the data were collected electronically by Survey Monkey. The mode, or most commonly occurring value, was selected as the threshold for the upper and lower alert limits for critical results reporting. RESULTS: A total of 666 laboratories submitted data to this study and, of these, 499 submitted complete responses. Full blood count critical results alert thresholds, morphology findings that trigger critical result notification, critical results alert list, notification process and maintenance of critical results management protocol are described. This international survey provided a snapshot of the current practice worldwide and has identified the existence of considerable heterogeneity of critical results management. CONCLUSION: The recommendations in this study represent a consensus of good laboratory practice. They are intended to encourage the implementation of a standardized critical results management protocol in the laboratory.

Critical values in hematology.

INTRODUCTION: Critical values are life-threatening results that require immediate notification to the patient's healthcare provider. Accreditation bodies require laboratories to establish critical values. A survey of Ontario laboratories was conducted to determine current practice for critical values in hematology. METHODS: The survey was sent to 182 participants questioning sources for establishing critical values, levels, review frequency, delta checks, and reporting. The survey was completed by laboratory managers, supervisors, technical specialists, senior technologists, and bench technologists working in hematology. RESULTS: The majority of participating laboratories have established critical values limits for hemoglobin, leukocyte counts, and platelet counts. Most laboratories also include the presence of malaria parasites and blast cells. Some laboratories reported the presence of plasma cells, sickle cells, schistocytes, and spherocytes as critical values. Multiple sources are used for establishing a critical value policy. There was variability for the frequency of critical values review. Rules may differ for a first-time patient sample vs. a repeat patient sample. Delta checks are seldom used to determine whether a result should be called a critical value. Most participants require the individual taking the critical result(s) to read back and confirm that they are directly involved with the patient's care. CONCLUSION: There is a lack of consensus for critical values reporting in hematology. As critical value reporting is crucial for patient safety, standardization of this practice would be beneficial.

ICSH guidelines for the verification and performance of automated cell counters for body fluids.

One of the many challenges facing laboratories is the verification of their automated Complete Blood Count cell counters for the enumeration of body fluids. These analyzers offer improved accuracy, precision, and efficiency in performing the enumeration of cells compared with manual methods. A patterns of practice survey was distributed to laboratories that participate in proficiency testing in Ontario, Canada, the United States, the United Kingdom, and Japan to determine the number of laboratories that are testing body fluids on automated analyzers and the performance specifications that were performed. Based on the results of this questionnaire, an International Working Group for the Verification and Performance of Automated Cell Counters for Body Fluids was formed by the International Council for Standardization in Hematology (ICSH) to prepare a set of guidelines to help laboratories plan and execute the verification of their automated cell counters to provide accurate and reliable results for automated body fluid counts. These guidelines were discussed at the ICSH General Assemblies and reviewed by an international panel of experts to achieve further consensus.

Performance evaluation of the latest fully automated hematology analyzers in a large, commercial laboratory setting: a 4-way, side-by-side study.

Gamma-Dynacare is a Canadian-based community laboratory partnership formed in the mid-1990s through the merger of 3 prominent Ontario medical diagnostic laboratories. Laboratory Corporation of America acquired an interest in the GD partnership in mid 2002. We service more than 10,000 community-based Canadian clinicians, hospital partners, and private clients with an integrated customer-focused system that includes specimen collection, transportation, and results reporting services. With more than 1,700 highly qualified medical, technical, and support staff and a network of laboratories, Gamma Dynacare aims to be at the forefront of technological innovation to better service the clinician base and ultimately deliver better patient care. We were looking for a hematology analyzer that would allow. (1) standardization throughout Ontario in our 4 largest sites and (2) better performance to effectively handle aged samples and minimize slide review. To select the best, most productive hematology analyzer for our environment, it was decided to perform a side-by-side comparison of the top hematology analyzers from Abbott (Cell-Dyn 3500), Beckman Coulter (LH 750), Bayer (Advia 120), and Sysmex (XE 2100), utilizing the same samples. CBC, differential and reticulocyte parameters were all evaluated according to CLSI (formerly NCCLS) and established hematology analyzer evaluation guidelines. We assessed each analyzer for precision, linearity, carryover, stability, differential capabilities, slide review rates, and throughput (clean bench studies). Two hundred samples were assessed for differential and morphology flagging on each analyzer using the reference 400 cell manual differential for comparison. Throughput was assessed by analyzing 700 consecutive samples representative of our workload mix. Stability studies at 24 hours showed that the Beckman Coulter LH 750 was least affected by EDTA, effect with minimal changes in the mean corpuscular volume (MCV) and hematocrit. Both the Bayer Advia 120 and Sysmex XE 2100 showed an elevation of the MCV (up to 5 fL) and Hematocrit over the 24 hours. Analysis of the 200 randomly selected patient samples showed that, while the false-negative rates on each of the instruments were comparable, there were significant differences in the false-positive rates. This has important implications for slide review rates. For our specimen mix, the Sysmex XE 2100 had the highest false-positive rate (15%), followed by the Cell-Dyn 3500 (8%), Advia 120 (6.5%) and the Beckman Coulter LH 750 (1.5%). Reticulocyte analysis performance was observed to be satisfactory with the Beckman Coulter LH 750, Cell-Dyn 3500, and XE 2100, while the Bayer Advia 120 showed a decrease in retic values after 12 hours. In conclusion, many laboratories will not be able to perform a 4-way evaluation such as described here due to time, space, and resource constraints. For our laboratories, result quality, sample stability performance, slide review rates, and efficiency were the primary criteria in selection of the most suitable hematology analyzer. Our 4-way evaluation resulted in selection of the Beckman Coulter LH 750 for Gamma-Dynacare Laboratories because it enabled the lowest slide review rate and handled aged samples better than the other analyzers.