Harmonizing factor assay-related testing performed in a large laboratory network.

Coagulation factor testing is commonly performed within haemostasis laboratories, either to assess for bleeding disorders, such as haemophilia, or to investigate unexplained prolongation in routine coagulation assays. The aim of this evaluation was to harmonize procedures and normal reference ranges (NRRs) for investigation of coagulation factors on the ACL TOP 50 family of instruments in a large laboratory network. We employed comparative evaluations using newly installed ACL TOPs 550 and 750 and HemosIL reagents vs. existing 'reference' instrumentation and reagents, predominantly Stago and Siemens, as well as assessment of factor sensitivity in routine coagulation assays, prothrombin time (PT) and activated partial thromboplastin time (APTT). Also, establishment of coagulation factor NRRs using normal plasma samples. HemosIL factor assays showed good comparability with the existing reference methods ( R > 0.9). Factor sensitivity for PT and APTT assays were acceptable at around 30 U/dl. NRRs were established and harmonized across the laboratory network. This evaluation of factor testing on ACL TOP 50 Family instruments identified overall acceptable performance using Werfen reagents and enabled harmonization of coagulation factor testing in our large network.

Harmonizing platelet function analyzer testing and reporting in a large laboratory network.

INTRODUCTION: The platelet function analyzer (PFA) is a popular platelet function screening instrument, highly sensitive to von Willebrand disease (VWD) and to aspirin therapy, with moderate sensitivity to defects in platelet function and/or deficiencies in platelet number. There are two models, the original PFA-100 and the contemporary PFA-200. Normal reference ranges (NRRs) provided by the manufacturer are the same for both models, instead being based on the type of test cartridge, for which there are two main ones: collagen/epinephrine (C/Epi) and collagen/adenosine diphosphate (C/ADP). METHODS: Comparative evaluations of PFA testing and reporting in six different sites of a large pathology network, aiming to harmonize NRRs and test reporting across all network sites. A separate comparative study of testing a range of samples (n > 150) on a PFA-100 versus that on a PFA-200. Review of contemporary literature. RESULTS: Each site was identified to have a different reporting NRR, which after consolidating data permitted establishment of an agreed harmonized NRR for use across the network (C/Epi: 90-160; C/ADP: 70-124; based on n > 180). Similarly, each site reported and interpreted results in different ways, and after discussion and consolidation, a harmonized approach to interpretation and reporting was achieved. The separate comparative study of PFA-100 versus PFA-200 testing confirmed instrument equivalence. CONCLUSION: We achieved harmonized NRRs and reporting for PFA testing across a large pathology network. Our approach may be useful for other laboratory networks wishing to harmonize PFA testing.

A multi-laboratory assessment of lupus anticoagulant assays performed on the ACL TOP 50 family for harmonized testing in a large laboratory network.

INTRODUCTION: Lupus anticoagulant (LA) testing is commonly performed within hemostasis laboratories, and the ACL TOP 50 family of instruments represent a new "single platform" of hemostasis instrumentation. Our aim was to evaluate these instruments and manufacturer reagents or alternatives for utility in LA testing. METHODS: Comparative evaluations of LA testing using newly installed ACL TOPs 550 and 750 as well as comparative assessments with existing "reference," predominantly Stago, instrumentation, and reagents. Evaluations comprised both dilute Russell viper venom time (dRVVT) and activated partial thromboplastin time (APTT)-based assays. Establishment of normal reference ranges (NRR). RESULTS: The HemosIL dRVVT-based assays showed good comparability with the existing Stago reference method (R > 0.9) and could be considered as verified as fit for purpose. A variety of APTT assays was additionally evaluated for LA utility, and we identified from the assessment good utility of a non-Werfen solution in Hyphen BioMed Cephen reagents. NRR were established based on ≥120 normal individual plasma samples. CONCLUSION: This evaluation of LA reagents on ACL TOP 50 Family instruments identified overall acceptable performance of both dRVVT (Werfen solution) and APTT (non-Werfen solution) to enable harmonization of LA testing in our large network.

A multi-laboratory assessment of congenital thrombophilia assays performed on the ACL TOP 50 family for harmonisation of thrombophilia testing in a large laboratory network.

OBJECTIVES: Thrombophilia testing is commonly performed within hemostasis laboratories, and the ACL TOP 50 family of instruments represent a new 'single platform' of hemostasis instrumentation. The study objective was to evaluate these instruments and manufacturer reagents for utility of congenital thrombophilia assays. METHODS: Comparative evaluations of various congenital thrombophilia assays (protein C [PC], protein S [PS], antithrombin [AT], activated protein C resistance [APCR]) using newly installed ACL TOPs 550 and 750 as well as comparative assessments with existing, predominantly STAGO, instrumentation and reagents. Verification of manufacturer assay normal reference ranges (NRRs). RESULTS: HemosIL PC and free PS assays showed good comparability with existing Stago methods (R>0.9) and could be considered as verified as fit for purpose. HemosIL AT showed high relative bias with samples from patients on direct anti-Xa agents, compromising utility. Manufacturer NRRs for PC, PS and AT were verified with minor variance. Given the interference with direct anti-Xa agents, an alternate assay (Hyphen) was evaluated for AT, and the NRR also verified. The HemosIL Factor V Leiden (APC Resistance V) evidenced relatively poor performance compared to existing assays, and could not be adopted for use in our network. CONCLUSIONS: This evaluation of HemosIL reagents on ACL TOP 50 family instruments identified overall acceptable performance of only two (PC, free PS) of four thrombophilia assays, requiring use of third-party reagents on ACL instruments for the other two assays (AT, APCR).

Verification of the ACL Top 50 Family (350, 550, and 750) for Harmonization of Routine Coagulation Assays in a Large Network of 60 Laboratories.

OBJECTIVES: To verify a single platform of hemostasis instrumentation, the ACL TOP 50 Family, comprising 350, 550, and 750 instruments, across a large network of 60 laboratories. METHODS: Comparative evaluations of instrument classes (350 vs 550 and 750) were performed using a large battery of test samples for routine coagulation tests, comprising prothrombin time/international normalized ratio, activated partial thromboplastin time (APTT), thrombin time, fibrinogen and D-dimer, and using HemosIL reagents. Comparisons were also made against existing equipment (Diagnostica Stago Satellite, Compact, and STA-R Evolution) and existing reagents to satisfy national accreditation standards. Verification of manufacturer normal reference ranges (NRRs) and generation of an APTT heparin therapeutic range were undertaken. RESULTS: The three instrument types were verified as a single instrument class, which will permit standardization of methods and NRRs across all instruments (n = 75) to be deployed in 60 laboratories. In particular, ACL TOP 350 test result data were similar to ACL TOP 550 and 750 and showed no to limited bias. All manufacturer NRRs were verified with occasional minor variance. CONCLUSIONS: This ACL TOP 50 Family (350, 550, and 750) verification will enable harmonization of routine coagulation across all laboratories in the largest public pathology network in Australia.

Use of Virtual Reality to Distract From Pain and Anxiety.

OBJECTIVES: To determine the effects of a virtual reality intervention on pain and anxiety in patients undergoing a bone marrow aspiration and biopsy procedure. SAMPLE & SETTING: 97 adults in an outpatient cancer center in the midwestern United States. METHODS & VARIABLES: In this quasiexperimental study, participants were assigned to either the experimental group (use of virtual reality goggles) or the control group (standard treatment). Vital signs, pain, and anxiety were measured before and after the procedure. T tests and chi-square tests were used to compare the two groups based on demographic data, pain, anxiety, and total amount of medication used during the procedure. RESULTS: Participants who wore virtual reality goggles during a bone marrow aspiration and biopsy procedure did not experience a statistically significant decrease in pain and anxiety. However, the experimental and control groups showed a decrease in pain and anxiety levels from pre- to postprocedure. IMPLICATIONS FOR NURSING: Virtual reality goggles may be a feasible, noninvasive alternative to traditional pharmacologic treatment. The cost of any intervention would need to be considered. Virtual reality should be researched and adapted to benefit patients in appropriate settings.

Felty's Syndrome: A Qualitative Case Study.

Felty's syndrome is a triad of rheumatoid arthritis, splenomegaly, and neutropenia. This rare disorder is difficult to diagnose and produces many complications. The purpose of this descriptive qualitative case study was to provide a comprehensive, context-bound understanding of one patient's struggle with the condition.

Underdeveloped Themes in Qualitative Research: Relationship With Interviews and Analysis.

PURPOSE: In this methodological article, the authors address the problem of underdeveloped themes in qualitative studies they have reviewed. Various possible reasons for underdeveloped themes are examined, and suggestions offered. ORGANIZING CONSTRUCT: Each problem area is explored, and literature support is provided. The suggestions that are offered are supported by the literature as well. FINDINGS: The problem with underdeveloped themes in certain articles is related to 3 interconnected issues: (a) lack of clear relationship to the underlying research method, (b) an apparent lack of depth in interviewing techniques, and (c) lack of depth in the analysis. Underdeveloped themes in a qualitative study can lead to a lack of substantive findings that have meaningful implications for practice, research, and the nursing profession, as well as the rejection of articles for publication. Fully developed themes require knowledge about the paradigm of qualitative research, the methodology that is proposed, the effective techniques of interviewing that can produce rich data with examples and experiences, and analysis that goes beyond superficial reporting of what the participants have said. Analytic problem areas include premature closure, anxiety about how to analyze, and confusion about categories and themes. CONCLUSIONS: Effective qualitative research takes time and effort and is not as easy as is sometimes presumed. The usefulness of findings depends on researchers improving their research skills and practices. IMPLICATIONS FOR PRACTICE: Increasingly researchers are using qualitative research to explore clinically important issues. As consumers of research or members of a research team, clinical nurse specialists need to understand the nature of this research that can provide in-depth insight and meaning.