Effective stewardship strategies to enhance appropriateness of refer-out test requests in a Canadian tertiary centre laboratory.

OBJECTIVES: Specialized testing conducted in reference laboratories is costly and often not optimally directed. Since 2016, our institution has worked to ensure the appropriateness of refer-out (RO) tests. We examine the impact of utilization initiatives on the patterns of requests and completed tests. DESIGN AND METHODS: In 2016, 81 RO tests were selected for a more rigorous approval process. Physicians not pre-approved for testing received a prompt to consult with laboratory subject matter experts (SMEs) for further detail. After review, SMEs provided responses, approving or rejecting requests based on clinical relevance. Stewardship activities also included: repatriating tests locally, preferring Canadian over foreign institutions, unbundling tests, distributing educational memos, and introducing staged testing. We collected data on the number of requested (NoR) and number of completed (NoC) tests in 2015, before the implementation of the new vetting procedures, and for the post-implementation phase from 2016-2022. RESULTS: For 62 targeted RO tests (including trace metals, vitamins, antibodies, and endocrine-related tests), there was a 33% reduction in NoR and a 51% reduction in NoC in 2022 compared to 2015. The total savings for the study period based on NoC was $807,736. The NoC rate for Neuronal antibody tests decreased to 48.6% in 2022, with cost savings of $17,123, and an additional $50,000 saved by changing the testing site. Insourcing apolipoprotein B and fecal calprotectin tests resulted in cost savings of $3,380 and $3,371, respectively, in 2022. CONCLUSIONS: Automated messaging followed by a formal review of RO test requests is an effective utilization strategy that prevents redundant or clinically unjustified testing. This approach leads to significant economic savings and is expected to improve the efficiency of patient care.

Imprecision of high-sensitivity cardiac troponin assays at the female 99th-percentile.

BACKGROUND: An analytical benchmark for high-sensitivity cardiac troponin (hs-cTn) assays is to achieve a coefficient of variation (CV) of ≤ 10.0 % at the 99th percentile upper reference limit (URL) used for the diagnosis of myocardial infarction. Few prospective multicenter studies have evaluated assay imprecision and none have determined precision at the female URL which is lower than the male URL for all cardiac troponin assays. METHODS: Human serum and plasma matrix samples were constructed to yield hs-cTn concentrations near the female URLs for the Abbott, Beckman, Roche, and Siemens hs-cTn assays. These materials were sent (on dry ice) to 35 Canadian hospital laboratories (n = 64 instruments evaluated) participating in a larger clinical trial, with instructions for storage, handling, and monthly testing over one year. The mean concentration, standard deviation, and CV for each instrument type and an overall pooled CV for each manufacturer were calculated. RESULTS: The CVs for all individual instruments and overall were ≤ 10.0 % for two manufacturers (Abbott CVpooled = 6.3 % and Beckman CVpooled = 7.0 %). One of four Siemens Atellica instruments yielded a CV > 10.0 % (CVpooled = 7.7 %), whereas 15 of 41 Roche instruments yielded CVs > 10.0 % at the female URL of 9 ng/L used worldwide (6 cobas e411, 1 cobas e601, 4 cobas e602, and 4 cobas e801) (CVpooled = 11.7 %). Four Roche instruments also yielded CVs > 10.0 % near the female URL of 14 ng/L used in the United States (CVpooled = 8.5 %). CONCLUSIONS: The number of instruments achieving a CV ≤ 10.0 % at the female 99th-percentile URL varies by manufacturer and by instrument. Monitoring assay precision at the female URL is necessary for some assays to ensure optimal use of this threshold in clinical practice.

Candidate recommendations for protein electrophoresis reporting from the Canadian Society of Clinical Chemists Monoclonal Gammopathy Working Group.

Protein electrophoresis is commonly used as an aid in the diagnosis of monoclonal gammopathies and is performed in many laboratories in Canada and throughout the world. However, unlike many other diagnostic tests, there is limited guidance for standardization and neither guidance nor specific recommendations for clinical reporting of serum (SPE) or urine (UPE) protein electrophoresis and immunotyping available in the literature. Therefore, a Canadian effort was undertaken to recommend standards that cover all aspects of clinical reporting with an ultimate goal towards reporting standardization. The Canadian Society of Clinical Chemists (CSCC) Monoclonal Gammopathy Interest Group (MGIG), which is composed of CSCC members with an interest in protein electrophoresis, has formed a Monoclonal Gammopathy Working Group (MGWG) to take initial steps towards standardization of SPE, UPE and immunotyping. Candidate standardization recommendations were developed, discussed and voted upon by the MGWG. Candidate recommendations that achieved 90% agreement are presented as consensus recommendations. Recommendations that did not achieve 90% consensus remain candidate recommendations and are presented with accompanying MGWG discussion. Eleven consensus recommendations along with candidate recommendations for nomenclature, protein fraction reporting, test utilization, interference handling and interpretive reporting options are presented.

Multiple pre- and post-analytical lean approaches to the improvement of the laboratory turnaround time in a large core laboratory.

BACKGROUND: Core laboratory (CL), as a new business model, facilitates consolidation and integration of laboratory services to enhance efficiency and reduce costs. This study evaluates the impact of total laboratory automation system (TLA), electric track vehicle (ETV) system and auto-verification (AV) of results on overall turnaround time (TAT) (phlebotomy to reporting TAT: PR-TAT) within a CL setting. METHODS: Mean, median and percentage of outlier (OP) for PR-TAT were compared for pre- and post-CL eras using five representative tests based on different request priorities. Comparison studies were also carried out on the intra-laboratory TAT (in-lab to reporting TAT: IR-TAT) and the delivery TAT (phlebotomy to in-lab TAT: PI-TAT) to reflect the efficiency of the TLA (both before and after introducing result AV) and ETV systems respectively. RESULTS: Median PR-TATs for the urgent samples were reduced on average by 16% across all representative analytes. Median PR-TATs for the routine samples were curtailed by 51%, 50%, 49%, 34% and 22% for urea, potassium, thyroid stimulating hormone (TSH), complete blood count (CBC) and prothrombin time (PT) respectively. The shorter PR-TAT was attributed to a significant reduction of IR-TAT through the TLA. However, the median PI-TAT was delayed when the ETV was used. Application of various AV rules shortened the median IR-TATs for potassium and urea. However, the OP of PR-TAT for the STAT requests exceeding 60min were all higher than those from the pre-CL era. CONCLUSIONS: TLA and auto-verification rules help to efficiently manage substantial volumes of urgent and routine samples. However, the ETV application as it stands shows a negative impact on the PR-TAT.

Evaluation of the impact of a total automation system in a large core laboratory on turnaround time.

BACKGROUND: Growing financial and workload pressures on laboratories coupled with user demands for faster turnaround time (TAT) has steered the implementation of total laboratory automation (TLA). The current study evaluates the impact of a complex TLA on core laboratory efficiency through the analysis of the In-lab to Report TAT (IR-TAT) for five representative tests based on the different requested priorities. METHODS: Mean, median and outlier percentages (OP) for IR-TAT were determined following TLA implementation and where possible, compared to the pre-TLA era. RESULTS: The shortest mean IR-TAT via the priority lanes of the TLA was 22min for Complete Blood Count (CBC), followed by 34min, 39min and 40min for Prothrombin time (PT), urea and potassium testing respectively. The mean IR-TAT for STAT CBC loaded directly on to the analyzers was 5min shorter than that processed via the TLA. The mean IR-TATs for both STAT potassium and urea via offline centrifugation were comparable to that processed by the TLA. The longest mean IR-TAT via regular lanes of the TLA was 62min for Thyroid-Stimulating Hormone (TSH) while the shortest was 17min for CBC. All parameters for IR-TAT for CBC and PT tests decreased significantly post- TLA across all requested priorities in particular the outlier percentage (OP) at 30 and 60min. CONCLUSIONS: TLA helps to efficiently manage substantial volumes of samples across all requested priorities. Manual processing for small STAT volumes, at both the initial centrifugation stage and front loading directly on to analyzers, is however likely to yield the shortest IR-TAT.

An effective utilization management strategy by dual approach of influencing physician ordering and gate keeping.

OBJECTIVES: There is increasing recognition of the importance of appropriate laboratory test utilization. We investigate the effect of a multifaceted educational approach that includes physician feedback on individual test ordering, in conjunction with targeted restriction, on the utilization of selected laboratory tests. DESIGN AND METHODS: Scientific evidence was compiled on the usefulness and limitations of tests suspected of being over utilized in our laboratories. A variety of approaches were used to deliver education on each of the targeted tests, with greater focus on primary care physicians (PCPs). Feedback on requesting behavior of these tests was also communicated to the latter group which included an educational component. Laboratory based restriction of testing was also exercised, including the unbundling of our electrolyte panel. RESULTS: PCP requesting patterns for the selected tests were found to be markedly skewed. The interventions implemented over the study period resulted in a substantial 51% reduction in overall ordering of five of the targeted tests equating to an annual marginal cost saving of $60,124. Unbundling of the electrolyte panel resulted in marginal cost savings that equated annually to $42,500 on chloride and $48,000 on total CO2. CONCLUSIONS: A multifaceted educational approach combined with feedback on utilization and laboratory driven gate-keeping significantly reduced the number of laboratory tests suspected of being redundant or unjustifiably requested. Laboratory professionals are well positioned to manage demand on laboratory tests by utilizing evidence base in developing specific test ordering directives and gate-keeping rules.

Pushing the limits of chemistry point-of-care testing for the management of patients under investigation for Ebola virus disease.

BACKGROUND: With the recent outbreak in West Africa, hospitals worldwide have been developing protocols for suspect of cases of Ebola virus disease. Patients with Ebola virus disease present with a severe gastroenteritis leading to dehydration and electrolyte abnormalities and as such, routine chemistry analysis is essential for patient management. While point-of-care testing can be used with additional precautions for rapid chemistry analyses in a laboratory setting, significant delays could ensue before specimens arrive to the laboratory. This study evaluated the stability of eight chemistry analytes up to 4 h post-collection. METHODS: Blood was collected by venipuncture from 20 healthy volunteers and tested at times 0, 30, 60, 90, 120 and 240 h. Approximately 100 µl of blood was dispensed into a CHEM 8+Cartridge and processed on a model 300 i-STAT 1 Analyzer (Abbott Point of Care Inc.) and ANOVA was used to assess statistical significant difference from the initial time point. RESULTS: While the manufacturer recommends testing within 30 min of collection, no significant variation was observed for most analytes with time points extending up to 4 h. In contrast, glucose concentrations decreased significantly (P < 0.0001) over time at an average rate of 0.0032 mmol/L per min. CONCLUSIONS: This study provides supporting data suggesting that delays up to 4 h can be tolerated, giving ample time for collection and transport of specimens to the clinical laboratory. For glucose, POC testing could still be used, taking into account the collection time and the average rate of decrease.

Comparison of Becton Dickinson Vacutainer rapid serum tube with the serum separator tube for routine chemistry and immunoassay tests.

AIMS: To shorten the clotting time and resolve the delayed clotting or no clotting on specimens from patients on anticoagulant therapy, Becton Dickinson (BD) recently developed the Vacutainer rapid serum tube (RST). The aim of this study was to systematically compare the new RST tube with the widely used serum separator tube (SST) for routine chemistry and immunoassay tests on 3 common analyser platforms. METHODS: Blood from 45 people (24 women and 21 men, age 21-77 years) was collected using the SST and RST tubes in sequence. Sera from both tubes were separated and analysed simultaneously for 54, 50, and 10 chemistry and/or immunoassay tests on the Roche Modular, Abbott Architect, and Siemens Centaur analysers, respectively. RESULTS: The results from the RST tube were comparable with those from the SST tube on most analytes. Although the results for a few analytes showed statistically significant differences between the two tubes (p<0.05), the differences had no clinical significance for most assays. Only for parathyroid hormone on the Abbott Architect, the RST tube demonstrated clinical significant bias versus the SST tube (-15.3%, p<0.01). CONCLUSIONS: The RST tube provides acceptable performance for routine chemistry and immunoassay tests.