Michael Peter Cornes

High quality laboratory results are critical for patient management. However, poor sample quality can impact these results and patient safety. To ensure reliable and accurate results laboratories must be aware of each analyte’s stability under various storage conditions and matrices to guarantee correct and dependable outcomes. This knowledge allows laboratories to define the allowable delay between sample collection and centrifugation/analysis for all analytes to guarantee appropriate results quality and interpretation. The EFLM Working Group for the Preanalytical Phase (WG-PRE) therefore established a 4-step plan to tackle this issue, aiming to standardize and harmonize stability studies for improved comparison and meta-analysis. The plan included the development of checklists and how-to guides for performing and reporting stability studies as well as a central resource of stability data. This manuscript deals with the issue of evaluating publications and incorporating them into a central resource. To evaluate stability studies, the CRESS checklist was used to structure 20 sections used to judge the quality of studies. Each section has 4 levels of quality, with scores converted to numerical values and weighted based on expert opinion. Based on this, a final score ranging from A to D was determined. The procedure was then tested on six manuscripts and checked for agreement between expert judgements. The results demonstrated that the proposed evaluation process is a useful tool to distinguish between best in class manuscripts and those of lower quality. The EFLM WG-PRE strongly believes that the provided recommendations and checklists will help improving stability studies both in quality and standardisation.

Objectives: Knowledge of the stability of analytes in clinical specimens is a prerequisite for proper transport and preservation of samples to avoid laboratory errors. The new version of ISO 15189:2022 and the European directive 2017/746 increase the requirements on this topic for manufacturers and laboratories. Within the project to generate a stability database of European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group Preanalytical Phase (WG-PRE), the need to standardise and improve the quality of published stability studies has been detected, being a manifest deficit the absence of international guidelines for the performance of stability studies on clinical specimens. Methods: These recommendations have been developed and summarised by consensus of the WG-PRE and are intended primarily to improve the quality of sample stability claims included in information for users provided by assay supplier companies, according to the requirements of the new European regulations and standards for accreditation. Results: This document provides general recommendations for the performance of stability studies, oriented to the estimation of instability equations in the usual working conditions, allowing flexible adaptation of the maximum permissible error specifications to obtain stability limits adapted to the intended use. Conclusions: We present this recommendation based on the opinions of the EFLM WG-PRE group for the standardisation and improvement of stability studies, with the intention to improve the quality of the studies and the transferability of their results to laboratories.

Article Frontmatter was published on April 1, 2022 in the journal Clinical Chemistry and Laboratory Medicine (CCLM) (volume 60, issue 5).

Article Effectiveness of interventions to improve test appropriateness was published on January 20, 2022 in the journal Clinical Chemistry and Laboratory Medicine (CCLM) (volume 0, issue 0).

Background: Haemolysis, icterus and lipaemia (HIL) are common interferants in laboratory medicine, potentially impacting patient care. This survey investigates HIL management in medical laboratories across the UK and Republic of Ireland (ROI). Methods: A survey was sent to members of key professional organisations for laboratory medicine in the UK and ROI. Questions related to the detection, monitoring, quality control, and management of HIL. Results: In total, responses from 124 laboratories were analysed, predominantly from England (52%) and ROI (36%). Most responses were from public hospitals with biochemistry services (90%), serving primary care (91%), inpatients (91%), and outpatients (89%). Most laboratories monitored H (98%), I (88%), and L (96%) using automated indices (93%), alone or in combination with visual inspection. Manufacturer-stated cut-offs were used by 83% and were applied to general chemistries in 79%, and immunoassays in 50%. Where HIL cut-offs are breached, 64% withheld results, while 96% reported interference to users. HIL were defined using numeric scales (70%) and ordinal scales (26%). HIL targets exist in 35% of laboratories, and 54% have attempted to reduce HIL. Internal Quality Control for HIL was lacking in 62% of laboratories, and just 18% of respondents have participated in External Quality Assurance. Laboratories agree manufacturers should: standardise HIL reporting (94%), ensure comparability between platforms (94%), and provide information on HIL cross-reactivity (99%). Respondents (99%) showed interest in evidence-based, standardised HIL cut-offs. Conclusions: Most respondents monitor HIL, although the wide variation in practice may differentially affect clinical care. Laboratories seem receptive to education and advice on HIL management.

Ethnic differences in intact parathyroid hormone (iPTH) at similar total 25 hydroxyvitamin D [25(OH)D] concentrations have been reported between US resident Whites, Blacks, and Hispanics, but this has not been studied between South Asians and Whites. We, therefore, compared the iPTH relationship to 25(OH)D in UK resident South Asians and Whites. A comparative, cross-sectional observational study in which demographic and laboratory data on South Asian and White residents of Wolverhampton, UK were analyzed. Log-log models measured the association between 25(OH)D and the interaction term of ethnicity and iPTH. Seven hundred and seventy-two patients consisting of 315 white subjects (208 women) and 457 South Asian subjects (331 women) were studied. Compared to South Asians, White subjects were older, had higher serum concentrations of 25(OH)D, creatinine (lower eGFR), adjusted calcium and magnesium, but similar concentrations of iPTH and phosphate. In an adjusted model, variables significantly associated with 25(OH)D included age, creatinine, adjusted calcium and ethnicity; but not iPTH and the interaction term of ethnicity and iPTH (beta coefficient –0.071, 95% CI –0.209, 0.067, p=0.32). In our study cohort, iPTH was not, per se, influenced by 25 (OH)D. We found no ethnic differences in the association between iPTH and 25(OH)D between South Asians and White UK residents

Background: A patient survey developed by the Pre-Analytical Phase Special Interest Group of the Association for Clinical Biochemistry and Laboratory Medicine (ACB-PA-SIG) was conducted during November and December 2019. The survey aimed to determine the quality of information provided to patients in preparation for their blood test(s). In addition, the ACB-PA-SIG provide a number of recommendations, which, if adopted, may yield higher quality test results and improve patient management. Methods: The survey was distributed at phlebotomy suites in two Hospitals: Ipswich Hospital (United Kingdom [UK]), and Cork University Hospital (Republic of Ireland [RoI]). Results: Overall, 235 survey responses were received from the two sites. A total of 103 respondents received no information about preparing for their blood test and 92 had been told they did not need to fast. None of the patients surveyed had been instructed to fast for 12 h. Twenty-two patients had been told to avoid certain foods, drinks or medication, 14 were told to avoid strenuous activity and 41 respondents had been informed of the need to avoid alcohol/smoking prior to their blood test. Overall, only approximately 78 felt well informed about the blood taking process. Conclusions: Based on the results of this survey, the ACB-PA-SIG conclude that: (1) clinicians should provide clear written information to patients regarding pre-analytical requirements; and (2) effective communication between laboratories and General Practitioners is required to disseminate information. In this paper, the ACB-PA-SIG provide a list of pre-analytical recommendations to standardize and improve practice across the UK and RoI.

To ensure that clinical laboratories produce results that are both accurate and of clinical utility it is essential that only samples of adequate quality are analysed. Although various studies and databases assessing the stability of analytes in different settings do exist, guidance on how to perform and report stability studies is lacking. This results in studies that often do not report essential information, thus compromising transferability of the data. The aim of this manuscript is to describe the C hecklist for R eporting S tability S tudies (CRESS) against which future studies should be reported to ensure standardisation of reporting and easy assessment of transferability of studies to other healthcare settings. The EFLM WG-PRE (European Federation of Clinical Chemistry and Laboratory Medicine Working Group for the Preanalytical Phase) produced the CRESS checklist following a detailed literature review and extensive discussions resulting in consensus agreement. The checklist consists of 20 items covering all the aspects that should be considered when producing a report on a stability study including details of what should be included for each item and a rationale as to why. Adherence to the CRESS checklist will ensure that studies are reported in a transparent and replicable way. This will allow other laboratories to assess whether published data meet the stability criteria required in their own particular healthcare scenario. The EFLM WG-PRE encourage researchers and authors to use the CRESS checklist as a guide to planning stability studies and to produce standardised reporting of future stability studies.

Background: Specimen labelling and patient identification are significant contributors to the rate of error in the preanalytical phase of laboratory medicine. This study aimed to investigate the prevalence and nature of preanalytical quality monitoring practices for patient identification and specimen labelling errors in Irish clinical laboratories. Methods: A survey was developed by the Clinical Biochemistry Unit, Trinity College Dublin and the Irish External Quality Assessment Scheme (IEQAS), with the intention of gathering key information from each laboratory. Thirty-nine questions were organized into seven subsections covering general information, labelling requirements, information availability, rejection criteria, error monitoring, error reporting and interest in participation in an external quality assessment scheme. The survey was sent electronically to 63 laboratory quality managers at 55 laboratories in Ireland. Results: A total of 39 responses (61% response rate) provided information on 94 separate laboratory departments or disciplines. Laboratories reported varying practices and requirements for labelling specimens and all accepted handwritten preprinted request forms. All (100%) respondents had defined rejection criteria both for specimen labelling and request form completion. Unsurprisingly, the rejection criteria differed between the various laboratory disciplines. Almost all respondents provided information to clinical staff on labelling requirements, but just over half provided training on the same. A large percentage of laboratories (74%) monitored the rate of specimen-labelling errors; however, only 46% had defined target limits for acceptable rates of error. Conclusion: The survey observed a wide variation in collection, recording and monitoring of errors but also confirmed significant interest in improving preanalytical monitoring and data collection.