ePoster Exhibition

A New External Quality Assessment Program for Laboratories that Detect H. pylori and Antimicrobial Resistant Markers Using Nucleic Acid Amplification Test Methods

Pavel Zhelev¹, Sydney Rivers¹, Heidi Berghäll², Kristel Virtanen², Kati Luiro², Qudus Aguda¹, Mehak Thakur¹, Amer Alagic¹, Mark Luscher¹, and Ken Hughes^1
1 Microbix Biosystems Inc, Mississauga, Canada
² Labquality, Helsinki, Finland

Helicobacter pylori (H. pylori) infection affects approximately half of the world’s population and continues to pose a serious threat to human health with the rise of antibiotic resistant strains1,2. Consequently, there is an urgent need for screening and diagnostic programs that accurately detect H. pylori infections and its antibiotic resistant markers2. Conventional microbiological diagnosis is based on culture; however, this technique has limitations as it is challenging to isolate the bacterium from gastric biopsy specimens and has prolonged turnaround times2. The emergence of non-invasive molecular diagnostic tests has become significant to promote rapid diagnosis and early treatment.

To ensure accurate and reliable testing, contrived specimens are required for External Quality Assessment (EQA) programs, assay validation, sensitivity and specificity assessment, laboratory personnel training, and routine quality control. However, existing liquid matrix formats frequently fall short in providing the required stability. The target degradation (antigen and nucleic acid) can compromise sample integrity, impeding accurate assessments of laboratory competency, especially in Point-of-Care Testing (POCT) setups.

Assessment of laboratory handling of low level
haemolysis interference in cases of hypokalaemia

Rosie Forster¹, Luke Hibberd², Finlay MacKenzie¹ and Rachel Marrington^1
1 Birmingham Quality (UK NEQAS), University Hospitals Birmingham NHS Foundation Trust
² Chemical Pathology (Biochemistry), Gloucestershire Hospitals NHS Foundation Trust,
Gloucestershire, UK

Potassium is one of the most frequently measured Clinical Biochemistry analytes and is also one of the analytes whose measurement is most severely impacted by haemolysis. Abnormal potassium results are life threatening and require urgent action – however the artefactual elevation in potassium in a haemolysed sample may mask low potassium (hypokalaemia). The Royal College of Pathologists recommends taking urgent action
when potassium concentration is lower than 2.5 mmol/L.

The UK NEQAS for Serum Indices EQA Scheme assesses the measurement of Haemolytic (H), Icteric (I) and Lipaemic (L) indices. There are over 700 participants currently in the scheme. Participants are also asked to report the concentration of a particular analyte that varies with each distribution, which we call “Analyte X”, and asked whether they would report the result when the HIL indices are taken into consideration. In Distribution 177 (September 2023), Analyte X was potassium. By gathering data from participants about their handling of low potassium results in
haemolysed samples, Birmingham Quality can drive improvement by helping laboratories to become more consistent in their practice.

Automation of the External Quality Assurance
process supporting compliance and quality
assurance

Sarah Appleby¹, Paudy O’Gorman^2
1 X-Lab Systems, Leeds, UK
² Mater Misericordiea University Hospital (MMUH), Dublin, Ireland

Maintaining quality assurance compliance is vital for the ongoing accuracy of results from all labs and for their continued adherence to quality standards. However, proficiency testing requests and results reporting are often done
using paper forms and manual data entry. This causes excessive demands on staff time and can often lead to data quality issues from pre- and post-transcription errors and potential compliance fails.

Bringing laboratory diagnostics closer to patient:
the advantages of preanalytical automation in E. Gulbis Laboratory

Jānis Stašulāns^1,2, Didzis Gavars^1,2, Egils Gulbis^1,2, Mikus Gavars¹, Justīne Grundmane^1,3, Anna Stašulāne^1,2
1 E. Gulbis laboratory
² Riga Stradins University
³ University of Latvia

E. Gulbis laboratory developed our own automated sample collection devices which are new additions in the medical
sector in Latvia and are equipped to handle various tests. This study primarily addresses the need for further development in the preanalytical phase automation in laboratory and hospital environment.

Educational Preanalytical Cases Support
End-to-end EQA in Urine Culture

Elina Tuovinen¹, Yvonne Björkman¹, Kristel Virtanen¹, Päivi Suomala², Jonna Pelanti¹, Heidi Berghäll^1
1 Labquality, Helsinki, Finland
² ISLAB Laboratory Center, South Savo, Finland

Labquality has introduced educational pre- and postanalytical cases to an increasing number of the traditional external quality assessment (EQA) schemes; a service named integrated EQA (EQA3), starting in 2017. This helps clinical laboratories and point-of-care testing (POCT) sites to meet the end-to-end requirements of the ISO 15189 standard, which states that all steps of the laboratory process should be monitored. In Labquality’s scheme for urine culture, the EQA3 service has been provided since 2018. According to the results of a questionnaire in 2023, the participants find the EQA3 service suitable for their needs.

How to use your EQA data to support Risk Assessment
within your ISO 15189:2022 accreditation

Rachel Marrington, Rosie Forster, Yevheniia Mikheenko and Finlay MacKenzie
Birmingham Quality (UK NEQAS), University Hospitals Birmingham NHS Foundation Trust

ISO15189:2022 puts an emphasis on a risk-based approach within the laboratory. Laboratories are responsible for ensuring that they are using assays that are fit for the purpose that the laboratory intends to use them for, and that if there are any changes in assay performance these are taken into consideration and communicated to users.

External Quality Assessment (EQA) has two very important roles — a retrospective assessment of an individual laboratory’s quality and post market surveillance of all assays that are in use. There are differences in Scheme design between EQA providers. The laboratory should not assume that just because an assay is commercially available that it is fit for the purpose that they are using it for. Likewise, laboratories should not assume all EQA Schemes are the same.

Review of data to show how EQA data can be used to show how laboratories can use their EQA data to support choice of assay, ongoing verification and overall assay fitness for purpose. An example is shown for Serum Cortisol.

Laboratories benefit from directly integrating their LIS to EQA platform

Kristel Virtanen, Heidi Berghäll, Jonna Pelanti
Labquality, Helsinki, Finland

External quality assessment (EQA) samples should be analyzed following the same process as patient samples. Laboratories receive patient sample analysis requests electronically into their laboratory information system (LIS) and patient results are reported back electronically. EQA sample requests are usually not electronic, and results are reported manually on an electronic result form of the EQA provider. This additional and out-of-the-process step may cause delays, uncertainty or even errors in the EQA result reporting. Integrating LIS directly to EQA portals decreases
the manual workload for laboratories and makes result reporting faster and more consistent. It also helps clinical laboratories and point-of-care testing (POCT) sites to meet the requirements of the ISO 15189 standard. It states that pre- and post-examination processes should be included in EQA programs. Labquality, an independent EQA provider, has integrated several LIS to its electronic EQA platform LabScala using standard HL7 messaging. The aim of this study is to show that directly integrating LIS system to EQA portal for EQA result reporting benefits the participating laboratory.

Performance of NGOs POCT participants in
PNAEQ/Labquality HIV and Hepatitis B+C schemes in 2022

Ana Cardoso¹, Marsa Järvenpää², Juha Wahlstedt², Rosa Freitas³, Ana Faria^1
1 PNAEQ, Department of Epidemiology, National Institute of Health Dr. Ricardo Jorge, Lisbon, Portugal
² Labquality, Helsinki, Finland
³ Grupo de Ativistas em Tratamentos, Lisbon, Portugal

Point-of-care testing (POCT) is a diagnostic testing at/near the site of patient, performed by healthcare professionals ( laboratories, primary healthcare settings or pharmacies) or personnel with no professional background in laboratory medicine (community health workers from NGOs). However, to guarantee the reliability of results and the security of patient, POCT users must ensure External Quality Assurance (EQA). This is not an issue when healthcare professionals perform EQA schemes, but it implies a bigger responsibility to EQA provider when users have no healthcare education. This includes four moments: demonstrate to NGO’s participants the importance of participation in EQA schemes; be able to distribute control materials with large submission time of results; elaborate comprehensible instructions and reports; provide help and guidance to participants when needed. POCT users in community perform POCT EQA schemes in sexual infections such as HIV and Hepatitis B+C. These EQA schemes are available in PNAEQ with collaboration of Labquality. NGO’s order these schemes since 2018. This study focuses on their 2022 participation.

PNAEQ and Labquality Preanalytical Schemes in 2023

Ana Cardoso¹, Catarina Ventura¹, Pia Eloranta², Riitta Viertola², Marsa Järvenpää², Iida Silvo², Juha Wahlstedt², Ana  Faria^1
1 PNAEQ, Department of Epidemiology , National Institute of Health Dr. Ricardo Jorge, Lisbon , Portugal
² Labquality, Helsinki, Finland

According to ISO 15189 2012 1 laboratory shall participate in external quality assessment (EQA) programme and implement corrective actions when necessary These EQA programs should have the effect of checking entire examination process, as well as evaluate laboratory staff involved in the process In order to evaluate all the clinical process, most EQA organizers distribute preanalytical schemes to participants, in addition to analytical and post analytical schemes The Portuguese EQA Programme (PNAEQ) with collaboration of Labquality, offered nine preanalytical schemes in 2023

PNAEQ Internal Audits in Pre- and Post-Analytical Phase: 2022/2023

Catarina Ventura, Ana Cardoso, Ana Faria
PNAEQ, Department of Epidemiology, National Institute of Health Dr. Ricardo Jorge, Lisbon, Portugal

The National External Quality Assessment Program (PNAEQ) provides tools for carrying out External Quality Assessment in pre and post analytical phase, including Internal Audits, through scheme PNAEQ 3 F Audits of the Pre and Post Analytical Phases, since 2016. This tool allows verification and improvement of the process's effectiveness, and provides valuable insights to laboratory management about the course of work within the laboratory.

Production of External Quality Assessment Materials for Allergy Specific IgE Assay

Anna Lee, Jin-Hee Jang, Eun-Hee Seo
Department of Laboratory Medicine, Seoul Clinical Laboratories, Yong-in, South Korea

Accurate identification of specific immunoglobulin E (slgE) is crucial for diagnosing and managing various allergic diseases. In Korea, the us of slgE immunoassays for allergic disease diagnosis has surged, highlighting the need for robust external quality assessment (EQA) to standardize these assays.

Proficiency Testing in Autoimmune Disease Diagnoses: Ensuring Accuracy and Reliability

Henriette Zeuch
in.vent Diagnostica GmbH, Hennigsdorf, Germany

Autoimmune diseases, encompassing over 80 distinct conditions, are notoriously challenging to diagnose due to their complex and varied nature. Among these, collagenoses such as Systemic Lupus Erythematosus (SLE) and Sjögren's Syndrome are particularly difficult to identify. Diverse clinical manifestations, which can vary significantly in individual patients, are often mimicking different diseases and leading to potential misdiagnosis. The detection of autoantibodies, crucial for the diagnosis of these diseases, presents a complex and challenging task. It requires highly specialized laboratory tests, as different autoimmune diseases are associated with unique patterns of autoantibodies.

Reducing Turnaround Times (TaTs) by 90.4% with Lab2Lab Interoperability

Sarah Appleby¹, Paudy O’Gorman^2
1 X-Lab Systems, Leeds, UK
² Mater Misericordiea University Hospital (MMUH), Dublin, Republic of Ireland

The Mater Misericordiea University Hospital (MMUH) in Dublin, Ireland refers more than 20,000 samples per year to external laboratories. Before Labgnostic, each of these samples was managed manually through paper-based processes. These created significant overheads on staff time – from clinicians to IT professionals. All samples referred out needed to be followed up manually, and all results were primarily returned to the Mater on paper, through the post. These paper results needed to be time-stamped, signed, and then scanned against the relevant order in the Mater PAS (Patient Administration System) - causing a significant wait for results for clinicians.

Results of EQA Pilot Study for Faecal Immunological Tests (FIT) for Haemoglobin using a Novel Ready-to-Use Sample Material

Heidi Berghäll, Satu Eklund, Jonna Pelanti, Kristel Virtanen
Labquality, Helsinki, Finland

The primary screening method for colorectal cancer is faecal immunochemical tests (FIT) detecting human haemoglobin (hHb) in faeces. There are several tests on the market both for laboratory-based analyzers and point-of-care testing (POCT). To ensure high quality results, the tests should be monitored with appropriate quality assessment procedures including participation in external quality assessment (EQA) programs. By participating in an EQA program using a patient sample-like material, clinical laboratories and POCT sites can fulfil the ISO 15189
requirements of monitoring the complete laboratory process from pre- to postanalytical phases in addition to the quantitative analytical phase of FIT. Labquality has performed an EQA pilot study for FIT using a novel ready-to-use stool-like sample containing human haemoglobin. Here we present the first results of an international EQA pilot study using this sample material.