Webinar 2:
Building on the interests of the first session, we continued the conversation on raising quality standards in pathology labs with the second webinar in the series, featuring insights from Monash Health of Victoria, Australia.
This session spotlighted practical approaches to achieving excellence in laboratory quality control, internal quality assurance, and external quality assessment, with a strong emphasis on collaboration across roles. Mr Alex Laslowski, Principal Scientist at Monash Health, shared his institutionās practical framework for ensuring quality at every stage of the pathology workflow. His talk highlighted:
- Quality Control (QC): Best practices applied daily to safeguard reliability and consistency in test results.
- Internal Quality Assurance (IQA): Proactive monitoring systems and continual improvement initiatives designed to identify trends and drive process optimization.
- External Quality Assurance (EQA): The role of proficiency testing and systematic review in benchmarking performance and meeting international standards.
The session then transitioned into a panel discussion, moderated by Dr Richie Lazaro, and featured Professor Beena Kumar, experienced pathologist and an academic leader at Monash Health. Together, the panel explored how collaboration among clinicians, pathologists, and technical staff is key to sustaining high-quality outcomes. They also shared detailed, practical tips on:
- Fostering teamwork across different functions in the lab
- Building a culture of accountability and continual improvement
- Applying systematic approaches to achieve consistently strong QC results
Watch the webinar to listen to actionable strategies that strengthen lab quality systems and witness firsthand how multidisciplinary collaboration is central to moving from a lab from good to truly great.
Webinar 1:
In recent years, there has been a clear and growing demand for laboratory accreditation as pathology labs increasingly align with international standards such as CAP, ISO 15189, RCPA, and JCI. This shift reflects a focus not only on regulatory compliance but also on achieving sustainable improvements in quality, consistency, and performance. In this educational webinar, several experts detail what it takes for laboratories to transition from just good to truly great.
The session began with a presentation by Ms Lin Yi-Jyun, a senior medical technician from National Taiwan University Hospital, who offered a frontline perspective on quality practices. Her comprehensive presentation addressed key topics, including:
- Preparing for laboratory accreditation and fostering awareness among all staff to adapt to potential changes
- A systematic approach to maintaining quality control (QC) within the ISO 15189 accreditation framework
- Practical insights into fulfilling ISO 15189 requirements and overcoming challenges encountered during the accreditation process
This was followed by a panel discussion featuring three essential perspectives in the laboratory ā management, pathologists, and technicians ā to examine how each role contributes to achieving and sustaining quality excellence. These various perspectives are represented by Professor Songkhun Vinyuvat, Chairman of the Laboratory Accreditation Committee, Thailand, and Professor Zan Likun, a practising pathologist at Shanxi Provincial Cancer Hospital, China.
During the discussion, participants explored some of the most frequently asked questions, such as:
Ms Lin: In our lab, workflow automation and integration help reduce technique variability among different personnel, resulting in more consistent staining quality. The use of a barcode system also minimises staining errors, such as incorrect antibody usage. Furthermore, the VSS software records the IDs of stained cases, which supports record management.
Ms Lin: We use appendix tissue as a positive control for HE staining. Before a new assay is added to our routine testing, the pathologists should review relevant references to identify which diseases are expected to show positive staining results. Then, previously diagnosed cases with those diseases are used to validate the new antibody. Only antibodies that pass validation are implemented in routine testing. This process ensures that all routine assays have a positive control.
Ms Lin: Yes, it is indeed very important. In most ideal situations, the positive control should come from a recent specimen, and the tissue type should be as similar as possible to the test sample. However, in practice, identifying and preparing a suitable positive control can be time-consuming and labour-intensive. For some assays, positive cases are difficult to find, so sometimes we have to compromise and use older tissue samples instead.
Alternative practice to consider: Control tissue blocks should be processed using the same or closely matched fixation and processing methods as test specimens. Users should always refer back to the antibody’s method sheet to determine the appropriate type of control tissue to use.
There are currently no formal guidelines from external quality assurance (EQA) programs specifying a maximum age for tissue blocks used as controls in IHC. When using older tissue blocks as controls, it is essential to verify that the target antigen remains detectable and that staining performance remains consistent, as antigen stability may decline over time due to various conditions.
Ms Lin: Recent tissue samples are better. Appendix and tonsil tissues are widely used in our lab, as they can serve as positive control for a variety of assays such as CD markers, cytokeratins (CKs), Desmin, SMA, ALK(D5F3), etc.
Alternative practice to consider: Users should always refer to the antibody’s method sheet to determine the appropriate type of control tissue to use.
Ms Lin: Due to a lack of laboratory personnel, we run negative reagent controls only in PD-L1 assays.
Alternative practice to consider: Method sheets recommend the use of negative reagent controls (NRCs) for the proper interpretation of IHC assays. Every tissue block stained in an IHC assay is recommended to be accompanied by an NRC using a duplicate section from the same block. NRCs can confirm assay specificity and help to assess the degree of non-specific background staining. This in turn, detects false positive staining that might misinform the interpretation of patient IHC results.
Ms Lin: The tissue parts collected for diagnosis are stored as FFPE blocks. The remaining tissue is kept in formalin and typically disposed of after a few days.
Ms Lin: Let me take IHC staining in our lab as an example. Parallel testing for a new instrument typically involves staining with Vimentin to compare the results between the new and the old ones. Documentation includes instrument numbers, the date of parallel testing, the personnel who tested it, and the test results.
We currently have eight instruments in NTUH. In order to ensure that the accuracy and performance of each instrument meet the required standards, we perform cross-comparison staining among all machines using CD20 and Ki-67 assays every year. Our approach may not be perfect, but I hope it can be a useful reference.
Ms Lin: There is no requirement in ISO 15189 to check the QC of each slide. However, in our current lab practice, as long as time allows, we will check each single slide.
Ms Lin: When troubleshooting is required, we generally carry out a self-check to rule out any operator-related issues within the lab and then reach out to our vendorās support staff for help, if needed. Sometimes, they can identify issues such as clogged tubing in the machine, reagent problems, or dispensers that need to be replaced. In fact, when we review the staining results of positive control each day, we are also monitoring the staining performance of the instrument to ensure its stability.
Alternative practice to consider: When troubleshooting an immunohistochemistry staining issue, it is important to recognise that multiple potential root causes may be involved, including pre-analytical, reagent, instrumentation, and protocol-related factors. Users should carefully investigate the problem by systematically reviewing all available information, such as control results, assay history, reagent status, and instrument logs, to identify the most likely source and implement appropriate corrective actions.
By reviewing the staining results of the positive control and patient test specimens each day, users can effectively monitor the instrumentās performance and help ensure its ongoing stability.
Prof Zan: Yes, we use e-documentation. In our lab, parts of the data were recorded in e-documents. For example, lab reports, experimental records and quality control data can all be stored in e-documentation. This not only saves storage space but also makes the retrieval and searching for information more convenient.
We must ensure the accuracy, authenticity and security of the data recorded in e-documents. So, we need the information system to help us record the data objectively and truthfully. And the system includes functions such as quality control data extraction, analysis, and permission management. For example, when an experimental report needs to be updated, the system should be able to automatically record the change history and ensure that only authorised personnel can make the modifications. The information department of the hospital is also called upon to assist us in ensuring data safety. We have appointed dedicated information managers, responsible for information management and communication.
Prof Zan: Using the sample tracking system in the laboratory is a crucial step, as it ensures the accuracy and traceability of experimental data. In our lab, each sample has a unique barcode identifier for easy tracking and management. We also use a software system to help us record and track the sample electronically. Currently, our information system is mainly used for the automatic recording of work processes, including operation time and the names of the operators. This allows checking of information at any time. We also can track the record and operator when we find problem, and correct in time. All the data can be exported for analysis.
In addition, we also use the reagent and consumables management information system. All consumables and reagents have stock in-out records, which helps us scientifically and reasonably make plans and manage the reagents and consumables.
The sample tracking system ensures the efficient management of lab samples and the accuracy of data. Whether it is a manual or electronic system, its core objective is to guarantee the authenticity of the experimental process and the reliability of the results.
