A Novel Approach for Routinely Assessing Laboratory Sigma Metrics for a Broad Range of Automated Assays.

BACKGROUND: Sigma metrics have been adapted for the clinical laboratory to incorporate observed accuracy, precision, and total error allowed. The higher the Sigma level for a process, the better performance that process has. A limitation of studies assessing Sigma metrics is that they are performed on a small number of well-controlled systems. METHODS: An algorithm was developed to extract QC data and derive the Sigma metric for 115 analytes from sites connected to the QuidelOrtho E-Connectivity® database. The median of these results was then used to derive the Sigma metric for each assay. RESULTS: In this analysis, 79 out of 115 (68.7%) of the assays assessed achieved 6 Sigma or better and 98 out of 115 (85.2%) achieved 5 Sigma or better. CONCLUSIONS: This study has demonstrated a methodology that can be used to condense Sigma metrics from hundreds of analyzers into a single metric of assay quality. Because these analyzers are running in working laboratories from around the world, this analysis can serve as a baseline for understanding the assay performance achieved in the presence of variabilities such as lab-to-lab, instrument-to-instrument, material handling, environmental conditions, and reagent lot. The significant number of assays demonstrating high Sigma levels did so despite this variation. The ability of the methods reported here to include hundreds of analyzers represents a novel approach for assessing Sigma metrics in clinical laboratories.

Innovation, Automation and Informatics Improves Quality in Lerdsin Hospital, Thailand.

This paper describes a planned, continuous improvement journey, of a laboratory that has installed a system with a single sample touch from blood draw to result. To achieve this, physical connectivity of systems from phlebotomy through pre-analytical to the analytical phase were paired with informatics connectivity from the patient's national identity card to the hospital and laboratory informatics management systems (LIMS) and associated middleware. This allowed accurate time stamps to track turnaround time (TAT). TAT metrics were collected from the LIMS for inpatient, emergency room and outpatient samples and tests over a period of 7 months. This time span incorporated the 2-month period before automation was implemented. The results for all tests and specific tests are shown and the results of an analysis of the outpatient phlebotomy workflow are given. The implemented solution has improved outpatient TAT by over 54% and has shown that samples can be collected, and results obtained without touching the sample. Improving intra-laboratory TAT is an important quality goal for all laboratories. The implementation of automation is important in achieving this albeit more about obtaining predictable TAT. Automation does not necessarily improve TAT it removes variation which leads to predictable TAT (PTAT). Automation should only be considered with a strategic vision for the future as it is important to have clear goals and objectives based on the individual laboratories process and needs. Automating a poor process leads to an automated poor process. Here, an innovative use of automation, hardware and software has resulted in marked improvement in TAT across all samples processed in the central laboratory.

Imperative: reducing the environmental impact of clinical laboratories.

Clinical laboratories are significant contributors to the environmental burden of the planet. They have been slow to address the issues with a few exceptions, but it is highly encouraging to see the current impetus and ambition in this direction. This paper describes some of these initiatives and provides the rationale as to why clinical laboratories should become sustainable. It also describes the economic and intangible benefits that labs will accrue in achieving sustainability.

Reducing the Environmental Impact of Clinical Laboratories.

Healthcare is a significant contributor to environmental impact but this has received little attention. The typical laboratory uses far more energy and water per unit area than the typical office building. There is a need to sensitise laboratories to the importance of adopting good environmental practices. Since this comes at an initial cost, it is vital to obtain senior management support. Convincing management of the various tangible and intangible benefits that can accrue in the long run should help achieve this support. Many good environmental practices do not have a cost but will require a change in the culture and mind-set of the organisation. Continuing education and training are important keys to successful implementation of good practices. There is a need to undertake a rigorous cost-benefit analysis of every change that is introduced in going green. The adoption of good practices can eventually lead to ISO certification if this is desired. This paper provides suggestions that will allow a laboratory to start going green. It will allow the industry to enhance its corporate citizenship whilst improving its competitive advantage for long-term.

For the proposition: for the diagnosis of viral infections, commercial assays provide more reliable results than do in-house assays.

It cannot be disputed that in-house ('home brew') assays have a part to play in the diagnosis of emerging or evolving infections such as avian influenza H5N1. In such circumstances, diagnostic companies can provide Research Use Only (RUO) or analyte specific reagents (ASR) to facilitate development. In contrast, the provision of commercial assays is governed by regulatory approval and subject to regular audit by the relevant regulatory bodies to ensure continued quality process throughout the continuum of product management. From initial design, through to post-launch support, the process has to meet the requirements of the USA Food and Drug Administration (FDA) Quality System Regulation (FDA, 1996) as well as that of the international quality standards, for example ISO 9001 (Int. Standard ISO 9001, 2000). Because of the quality policies that are implemented in the commercial environment, I will argue that, where available, commercial assays should replace in-house methods in order to ensure long term reliability of results.

Comparison of the ADVIA Centaur and Abbott AxSYM immunoassay systems for a routine diagnostic virology laboratory.

BACKGROUND: Routine diagnostic laboratories are confronted with an ever-increasing workload with limited resources. Automation has provided some solutions to these challenges particularly high through put analysers such as the Abbott AxSYM. OBJECTIVE: The aim of the present study was to compare the performance of two automated immunoassay systems in a diagnostic virology laboratory. Samples previously tested using the Abbott AxSYM were tested with a recently introduced immunoassay analyser, the Bayer ADVIA Centaur, for six virology analytes: HBsAg, anti-HBc total, anti-HBc IgM, anti-HBs, anti-HCV and anti-HIV1/O/2. STUDY DESIGN: This study was a retrospective analysis of stored serum samples previously tested on the Abbott AxSYM. Samples giving discrepant results were tested by other alternative immunoassays and re-tested on the Abbott AxSYM in the same freeze-thaw cycle. RESULTS: Although the sensitivities of the two automated immunoassays were similar there was improved specificity demonstrated for anti-HIV and anti-HCV when using the ADVIA Centaur assays. The low background signals allowed resolution of samples previously shown to have indeterminate results for anti-HIV antibody in the AxSYM assay. In addition, samples shown to have Abbott AxSYM anti-HCV results that could not be confirmed by RIBA and HCV molecular methods were shown to be negative by the ADVIA Centaur assay.