Enhancing hemotherapy safety through pertinent diagnostic testing and electronic "provisional diagnosis" reporting: expanding roles for blood bank technologists in biovigilance and patient safety.

BACKGROUND: Suspected transfusion reaction (STR) investigations are foundational for biovigilance. Diagnostic evaluations performed by blood banks may prolong turnaround times (TATs) for final STR results reporting. We identified a quality improvement opportunity using diagnostic testing reflex algorithms and our hospital's patient electronic health record to enhance TATs regarding one aspect of STR results reporting. STUDY DESIGN AND METHODS: We conducted a descriptive quality improvement study of reported STR cases investigated by our hospital's blood bank from March 1, 2014, to December 31, 2016, using data obtained from consult reports/quality improvement databases examining the number and types of diagnostic algorithm reflex activations performed and the TATs for an electronic provisional diagnosis reporting (PDXR) related to them. RESULTS: A total of 461 STR events occurred during the study interval, of which 150 involved no reflex testing. In the remainder of cases (n = 311), a total of 448 reflex activations occurred. In those cases in which PDXR occurred (n = 446), the median PDXR TAT during the first month of implementation was 325 minutes, which progressively decreased to 70 minutes or less approximately 1 year after implementation. By the last quarter of 2015, median TATs were 60 minutes or less in length, where they remained for the duration of the study. CONCLUSION: Technologists using targeted diagnostic reflex arcs to expedite laboratory testing along with STR electronic PDXR improve communication and timely results/information dissemination, potentially aiding bedside hemotherapy-related clinical decision making.

Laboratory evaluation of clopidogrel responsiveness by platelet function and genetic methods.

Clopidogrel is a widely used antiplatelet agent that irreversibly inhibits platelet P2Y12 ADP receptors after conversion to an active metabolite. There are a number of laboratory tests capable of detecting clopidogrel-induced platelet inhibition and published literature correlates suboptimal clopidogrel response to adverse cardiovascular outcomes. Genetic polymorphisms are thought to affect conversion of the prodrug to the active metabolite, and the FDA has recently added a black-box warning to clopidogrel to highlight the effects of these polymorphisms on drug bioavailability and to inform prescribers about the availability of genetic testing. For these reasons, there is growing interest in the use of laboratory tests to monitor patients treated with clopidogrel. This article summarizes the currently available laboratory testing, including platelet function tests and genotyping for CYP2C19 variants.

Development of electronic medical record charting for hospital-based transfusion and apheresis medicine services: Early adoption perspectives.

BACKGROUND: Electronic medical records (EMRs) provide universal access to health care information across multidisciplinary lines. In pathology departments, transfusion and apheresis medicine services (TAMS) involved in direct patient care activities produce data and documentation that typically do not enter the EMR. Taking advantage of our institution's initiative for implementation of a paperless medical record, our TAMS division set out to develop an electronic charting (e-charting) strategy within the EMR. METHODS: A focus group of our hospital's transfusion committee consisting of transfusion medicine specialists, pathologists, residents, nurses, hemapheresis specialists, and information technologists was constituted and charged with the project. The group met periodically to implement e-charting TAMS workflow and produced electronic documents within the EMR (Cerner Millenium) for various service line functions. RESULTS: The interdisciplinary working group developed and implemented electronic versions of various paper-based clinical documentation used by these services. All electronic notes collectively gather and reside within a unique Transfusion Medicine Folder tab in the EMR, available to staff with access to patient charts. E-charting eliminated illegible handwritten notes, resulted in more consistent clinical documentation among staff, and provided greater realered. However, minor updates and corrections to documents as well as select work re-designs were required for optimal use of e-charting-time review/access of hemotherapy practices. No major impediments to workflow or inefficiencies have been encount by these services. CONCLUSION: Documentation of pathology subspecialty activities such as TAMS can be successfully incorporated into the EMR. E-charting by staff enhances communication and helps promote standardized documentation of patient care within and across service lines. Well-constructed electronic documents in the EMR may also enhance data mining, quality improvement, and biovigilance monitoring activities.

ADAMTS13 activity and inhibitor.

Thrombotic thrombocytopenic purpura (TTP) is often associated with acquired or congenital deficiency of the von Willebrand factor-cleaving metalloprotease, ADMATS13 (Lammle B et al., J Thromb Haemost 2005;3:1663-1675; Schneppenheim et al., Blood 2003;101:1845-1850). Although undetectable levels of enzyme activity (<10%) are diagnostic of inherited or acquired TTP in the correct clinical setting (absence is specific), not all patients diagnosed with TTP have severe protease deficiency, and it is therefore not recommended as an initial test for diagnosis (Copelovitch and Kaplan, Pediatr Nephrol, in press). Many prospective and retrospective studies have demonstrated that patients with severe protease deficiency have a higher likelihood of relapse, making it helpful as an indicator of recurrence. The short-term prognostic usefulness of ADAMTS13 testing during acute TTP warrants further investigation because of limited prospective studies (Ferrari S et al., Blood 2007;109:2815-2822; Peyvandi et al., Haematologica 2008;93:232-239).

Myelodysplastic syndrome with isolated deletion of chromosome 20q: an indolent disease with minimal morphological dysplasia and frequent thrombocytopenic presentation.

The present study analysed the clinicopathological features of nine myelodysplastic syndrome (MDS) patients in which del(20q) was the sole cytogenetic abnormality and a control group of 17 adult patients with idiopathic thrombocytopenic purpura (ITP). Seven of nine del(20q) patients were thrombocytopenic and six of nine were mildly anaemic at presentation. There was no significant morphological dysplasia identified in the del(20q) group as compared with the ITP group. These results indicate that MDS with del(20q) commonly presents with thrombocytopenia and has minimal morphological dysplasia. Cytogenetic analysis on adult patients undergoing bone marrow sampling for thrombocytopenia may help avoid misdiagnosis of MDS with del(20q) as ITP.

Fallopian tube prolapse mimicking aggressive angiomyxoma.

A 68-year-old woman presented with a 4-cm polypoid bleeding mass protruding from the vaginal apex 30 years after vaginal hysterectomy. Laparotomy did not confirm the clinical suspicion of bowel prolapse and led to resection of the mass. Microscopic examination revealed a hypocellular edematous lesion with glandular areas resembling fallopian tube epithelium. Condensation of eosinophilic fibrils around medium sized vessels was marked. This case of fallopian tube prolapse shows an unusual resemblance of aggressive angiomyxoma and thus poses a diagnostic pitfall.

Assessment of the diagnostic accuracy of the TDx-FLM II to predict fetal lung maturity.

BACKGROUND: Because respiratory distress syndrome (RDS) affects 1% of live births, accurate and rapid assessment of markers of fetal lung maturity is critical to clinicians in deciding whether to deliver a preterm infant. Our objective was to determine the optimal diagnostic cutoff value for the TDx-FLM II assay (Abbott Laboratories) for predicting clinically significant RDS. METHODS: Amniotic fluid TDx-FLM II data were collected retrospectively over 4 years. Women were included in the study if they had delivered within 72 h of TDx-FLM II testing and both the mother and infant charts could be reviewed. Women who had been treated with steroids and delivered unaffected infants were excluded from the analysis. The diagnosis of RDS was defined as infants who either were treated with surfactant and/or were placed on a ventilator and/or required continuous positive airway pressure for >1 day. RESULTS: A total of 185 women met all entry criteria (15 RDS, 170 non-RDS). A cutoff value for a mature result of >or=45 mg/g gave a sensitivity of 100% (95% confidence interval, 82-100%) and a specificity of 90% (95% confidence interval, 78-89%). CONCLUSIONS: The TDx-FLM II appears to predict clinically significant RDS when a cutoff of >or=45 mg/g is used for mature results. Further studies will be required to confirm these findings.