Report formatting in laboratory medicine - a call for harmony.

The results of medical laboratory testing are only useful if they lead to appropriate actions by medical practitioners and/or patients. An underappreciated component of the medical testing process is the transfer of the information from the laboratory report into the reader's brain. The format of laboratory reports can be determined by the testing laboratory, which may issue a formatted report, or by electronic systems receiving information from laboratories and controlling the report format. As doctors can receive information from many laboratories, interpreting information from reports in a safe and rapid manner is facilitated by having similar report layouts and formats. Using Australia as an example, there is a wide variation in report formats in spite of a body of work to define standards for reporting. In addition to standardising of report formats, consideration needs to be given to optimisation of report formatting to facilitate rapid and unambiguous reading of the report and also interpretation of the data. Innovative report formats have been developed by some laboratories; however, wide adoption has not followed. The need to balance uniformity of reporting with appropriate innovation is a challenge for safe reporting of laboratory results. This paper discusses the current status and opportunity for improvement in safety and efficiency of the reading of laboratory reports, using current practise and developments in Australia as examples.

Patient groups, clinicians and healthcare professionals agree - all test results need to be seen, understood and followed up.

Background Diagnostic testing provides integral information for the prevention, diagnosis, treatment and management of disease. Inadequate test result reporting and follow-up is a major risk to patient safety. Factors contributing to failure to follow-up test results include unclear delineation of responsibility about who is meant to act on a test result; poor coordination across different levels of care; and the absence of integrated health information systems for the efficient information communication. Methods A 2016 Australian Stakeholder Forum brought together over 30 representatives from 14 different consumer, clinical and management stakeholder organisations to discuss safe and effective test result communication, management and follow-up. Thematic analysis was conducted drawing on multimodal data collected in the form of observational fieldnotes and document artefacts produced by participants. Results The forum identified major challenges which pose immediate risks to patient safety. Participants recommended priorities for addressing issues relating to: (i) the governance of test result management processes; (ii) integration of health care processes through the utilisation of effective digital health solutions; and (iii) involving patients as key partners in the decision-making and care process. Conclusions Stakeholder groups diverged slightly in their priorities. Consumers highlighted the lack of patient involvement in the test result management process but were less concerned about standardisation of reports and critical result thresholds than pathologists. The forum foregrounded the need for a systems approach, capable of identifying and addressing interconnections and multiple factors that contribute to poor test result follow-up, with a strong emphasis on enhancing the contribution of patients.

Delivering safe and effective test-result communication, management and follow-up: a mixed-methods study protocol.

INTRODUCTION: The failure to follow-up pathology and medical imaging test results poses patient-safety risks which threaten the effectiveness, quality and safety of patient care. The objective of this project is to: (1) improve the effectiveness and safety of test-result management through the establishment of clear governance processes of communication, responsibility and accountability; (2) harness health information technology (IT) to inform and monitor test-result management; (3) enhance the contribution of consumers to the establishment of safe and effective test-result management systems. METHODS AND ANALYSIS: This convergent mixed-methods project triangulates three multistage studies at seven adult hospitals and one paediatric hospital in Australia.Study 1 adopts qualitative research approaches including semistructured interviews, focus groups and ethnographic observations to gain a better understanding of test-result communication and management practices in hospitals, and to identify patient-safety risks which require quality-improvement interventions.Study 2 analyses linked sets of routinely collected healthcare data to examine critical test-result thresholds and test-result notification processes. A controlled before-and-after study across three emergency departments will measure the impact of interventions (including the use of IT) developed to improve the safety and quality of test-result communication and management processes.Study 3 adopts a consumer-driven approach, including semistructured interviews, and the convening of consumer-reference groups and community forums. The qualitative data will identify mechanisms to enhance the role of consumers in test-management governance processes, and inform the direction of the research and the interpretation of findings. ETHICS AND DISSEMINATION: Ethical approval has been granted by the South Eastern Sydney Local Health District Human Research Ethics Committee and Macquarie University. Findings will be disseminated in academic, industry and consumer journals, newsletters and conferences.

Standardisation of test requesting and reporting for the electronic health record.

This paper is a review of the standardisation required to achieve interoperability for pathology test requesting and reporting. Interoperability is the ability of two parties, either human or machine, to exchange data or information in a manner that preserves shared meaning. This is needed to make healthcare safer, more efficient and more effective. Interoperability requires standardisation around: transmission of data; identification policies; information structures; common terminology; common understanding; and behavioural agreement. It is dependent on consensus. Each of these aspects is considered from the perspective of pathology requesting and reporting concluding that while much has been done, much remains to be done.

Recommendations for reporting and flagging of reference limits on pathology reports.

Surveys by the RCPA PITUS Project have shown significant variations in report rendering between Australasian Pathology Providers. The same project collected anecdotal evidence that this variation has led to the misunderstanding and misreading of results - a clinical safety issue. Recommendations are given for the rendering of reference limits on pathology reports, determination and rendering of result flags, and the documentation of sub-population partitions for reference intervals. These recommendations apply equally for paper or electronic reporting, but should not limit the use of novel techniques within electronic reports to convey additional meaning. PITUS Working Group 4 will publish draft recommendations for peer review and comment in relation to the above in the second half of 2014.

The history of pathology informatics: A global perspective.

Pathology informatics has evolved to varying levels around the world. The history of pathology informatics in different countries is a tale with many dimensions. At first glance, it is the familiar story of individuals solving problems that arise in their clinical practice to enhance efficiency, better manage (e.g., digitize) laboratory information, as well as exploit emerging information technologies. Under the surface, however, lie powerful resource, regulatory, and societal forces that helped shape our discipline into what it is today. In this monograph, for the first time in the history of our discipline, we collectively perform a global review of the field of pathology informatics. In doing so, we illustrate how general far-reaching trends such as the advent of computers, the Internet and digital imaging have affected pathology informatics in the world at large. Major drivers in the field included the need for pathologists to comply with national standards for health information technology and telepathology applications to meet the scarcity of pathology services and trained people in certain countries. Following trials by a multitude of investigators, not all of them successful, it is apparent that innovation alone did not assure the success of many informatics tools and solutions. Common, ongoing barriers to the widespread adoption of informatics devices include poor information technology infrastructure in undeveloped areas, the cost of technology, and regulatory issues. This review offers a deeper understanding of how pathology informatics historically developed and provides insights into what the promising future might hold.

Introduction into PPPM as a new paradigm of public health service: an integrative view.

In the present state of healthcare, usual medical care is generally given to the already diseased person, while the key link-personal health monitoring underlain by predictive, preventive, and personalised medicine (PPPM) techniques that are being intensively elaborated worldwide-is simply missing. It is this link, based on the recognition of subclinical conditions, prediction, and further preventive measures, that is capable of regulating morbidity and diminishing the rates of disability among able-bodied population, thus significantly cutting the traditionally high costs of treating the already diseased people. To achieve the above-mentioned goal-the elaboration of the PPPM concept and its practical implementation-it is necessary to create a fundamentally new strategy based upon the subclinical recognition of the signs-bioindicators of cryptic abnormalities long before the disease clinically manifests itself. The implementation of PPPM programme requires an adjusted technology for the proper interpretation of diagnostic data, which would allow for the current 'physician-patient' model to be gradually replaced by a novel model, 'medical advisor-healthy men-at-risk'. This is the reason for an additional need in organising combinatorial scientific, clinical, training and educational projects in the area of PPPM to elicit the content of this new branch of medicine.

Annealing of silica to reduce the concentration of isolated silanols and peak tailing in reverse phase liquid chromatography.

Non-porous, colloidal silica particles were annealed at three different temperatures, 800, 900 and 1050 °C. The adsorption of lysozyme, a probe of surface roughness, was consistent with progressively reduced surface roughness as temperature increased. The heat treated silica particles were rehydroxylated and then used to pack UHPLC columns. The cationic protein lysozyme was used to probe silanol activity, which exhibited progressively less tailing as the annealing temperature increased. FTIR spectroscopy confirmed that the abundance of isolated silanols on the surface was reduced by annealing at 900 °C or 1050 °C. FTIR also revealed that there was markedly increased hydrogen bonding of the isolated silanols to neighbors after rehydroxylation. These results combine to support the hypothesis that (a) isolated silanols on silica cause tailing in RP-LC and (b) nonplanar topography gives rise to isolated silanols.

Single-molecule probing of adsorption and diffusion on silica surfaces.

Single-molecule spectroscopy has emerged as a valuable tool in probing kinetics and dynamic equilibria in adsorption because advances in instrumentation and technology have enabled researchers to obtain high signal-to-noise ratios for common dyes at room temperature. Single-molecule spectroscopy was applied to the study of an important problem in chromatography: peak broadening and asymmetry in the chromatograms of pharmaceuticals, peptides, and proteins. Using DiI, a cationic dye that exhibits the same problematic chromatographic behavior, investigators showed that the adsorption sites that cause chromatographic problems are located at defects on the silica crystal surface.

Sintered silica colloidal crystals with fully hydroxylated surfaces.

Silica colloidal crystals require multiple processing steps before they are useful materials in analytical applications, such as chemical separations, microarrays, sensors, and total internal reflection microscopy. These chemical processing steps include calcination, sintering, surface rehydroxylation, and chemical modification, but these steps have not been fully characterized for colloidal crystals. Silica particles of nominally 200 nm in diameter were prepared, and FTIR, SEM, UV-visible spectroscopy, and refractive index measurements were used to study the changes in chemical composition, particle size, and particle density throughout the process. The final material is shown to be a durable, crack-free crystal of solid particles bearing a fully hydroxylated surface of silanols, which can then be chemically modified.

Probing topography and tailing for commercial stationary phases using AFM, FT-IR, and HPLC.

Atomic force microscopy was used to study surface characteristics of three chromatographic silica products: Agilent Zorbax SB300, Waters Symmetry 300, and Merck Chromolith. Each is modified with a monomeric C18 monolayer. Both topographic and adhesive force measurements were made for each product. Topographical images revealed that all three materials are as smooth as glass on the scale of 100 nm and below. Adhesive forces for all three materials were much lower and much more uniform than for chemically modified fused silica. FT-IR spectra for all three materials showed a low abundance of isolated silanols, thus explaining the low adhesion. Chromatograms of a cationic dye, 1,1'-didodecyl-3,3,3',3'-tetramethylindocarbocyanine perchlorate (DiI), ranging in concentration from 1 to 300 microM were obtained for each column. All three materials exhibited classic nonlinear tailing; the Zorbax exhibited fronting as well. Chromatographic simulations were performed for the Symmetry and Chromolith products to determine the number of strong adsorption sites. The AFM, FT-IR, and HPLC were all consistent in indicating that the Chromolith material had half as many strong adsorption sites as the Symmetry material. The Zorbax material exhibited a number of isolated silanols that was comparable to the other materials, yet its adhesive force suggested a less adsorptive material, and its chromatographic performance suggested a more adsorptive material. Its topography is discussed as a possible reason for its anomalous chromatographic behavior.

High-speed electroseparations inside silica colloidal crystals.

Crystals made from 200 nm silica colloids are hardened and chemically modified with chlorodimethyloctadecylsilane for use in electrically driven, reversed-phase separations. A van Deemter plot reveals extremely narrow peak widths for the separation of a cationic hydrophobic dye, DiI, with both the A and C terms 10-fold smaller than those for a conventional HPLC column. Electrically driven separations are demonstrated to be achieved in less than 10 s for three dyes differing in hydrophobicity and also for three peptides differing in electrophoretic mobility. The results show that these media are promising for high-speed separations.