In personalized medicine, predictive biomarker testing is the basis for an appropriate choice of therapy for patients with cancer. An important tool for laboratories to ensure accurate results is participation in external quality assurance (EQA) programs. Several providers offer predictive EQA programs for different cancer types, test methods, and sample types. In 2013, a guideline was published on the requirements for organizing high-quality EQA programs in molecular pathology. Now, after six years, steps were taken to further harmonize these EQA programs as an initiative by IQNPath ABSL, an umbrella organization founded by various EQA providers. This revision is based on current knowledge, adds recommendations for programs developed for predictive biomarkers by in situ methodologies (immunohistochemistry and in situ hybridization), and emphasized transparency and an evidence-based approach. In addition, this updated version also has the aim to give an overview of current practices from various EQA providers.

<b><i>Background:</i></b> The Royal College of Pathologists of Australasia Quality Assurance Programs (RCPAQAP) is a world leader in the provision of external quality assurance (EQA) for pathology laboratories. The development and delivery of new programmes are designed to meet the evolving needs of our participants and pathology practice. A cytopathology technical programme was established in 2018 to provide proficiency testing in routine cytopreparatory techniques. The cytopathology technical pilot focused on standard operating procedures and laboratory performance during rapid on-site evaluation (ROSE). The exercise aimed to assess the diagnostic adequacy and provide technical recommendations on each of the whole slide images from four fine-needle aspiration biopsy (FNAB) samples of the thyroid in a setting of ROSE. <b><i>Methods:</i></b> Four whole slide imaging cases, each comprising one Diff-Quik^TM stained preparation of an FNAB of the thyroid, were provided to all laboratories currently enrolled in the RCPAQAP Cytopathology diagnostic programmes. Each scanned image represented one slide from the first pass collected by a radiologist under ultrasound guidance. Participating laboratories were encouraged to distribute the exercise to individual staff members who attend ROSE procedures. A laboratory practice questionnaire was also conducted. <b><i>Results:</i></b> There were a total of 186 submissions received for the assessment across the four virtual cases provided. Although the assessment of on-site adequacy by participants showed high concordance across some of the cases, there was variation in the initial diagnostic evaluation and technical recommendation. <b><i>Conclusions:</i></b> ROSE has been adopted as a standard procedure in many laboratories worldwide. A peer comparison of participating laboratories in an EQA exercise has highlighted ROSE as susceptible to variation across standard operating procedures, the provision of diagnostic adequacy, diagnostic feedback to the attending clinician, and technical recommendation.

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Background: The Royal College of Pathologists of Australasia Quality Assurance Programs (RCPAQAP) offers a comprehensive range of External Quality Assurance programs for all disciplines of pathology and is committed to delivering programs to advance outcomes in patient care and promote excellence in laboratory diagnostic and technical proficiency. Proficiency testing in cytopreparatory techniques became available for formal enrolment in 2018. The 2019 technical program focused on the demonstration of a laboratory to troubleshoot problems encountered during staining and processing. The exercise provided a peer comparison of a laboratory’s ability to (1) identify the problem viewed from a digital image and (2) describe the troubleshooting steps to rectify the problem using assessment guidelines. Methods: Ten troubleshooting exercises including whole-slide z-stacked virtual images, a reference slide, and an online Result Entry questionnaire were provided. Common staining and processing problems were demonstrated in these exercises. Multiple-choice responses were made available to participants for each case with 1 response requiring submission. Participants were then allowed free text to describe how they would rectify the problem. Results: Of the 72 participants who participated, 62 participants (86%) achieved a satisfactory assessment, 6 participants (8%) received a borderline assessment, and 4 participants (6%) received an unsatisfactory assessment. The average mark obtained was 32.7 out of a total of 45 marks, which equates to a satisfactory assessment. The highest mark obtained for this survey was 42.5. Conclusions: Quality cytopathology preparatory techniques are integral to mitigating the risk of diagnostic error. The digital pathology platform allowed homogeneity of samples for all participants and appeared to be a satisfactory mode for demonstrating the technical problems to participants. Laboratories participating in this survey showed good performance in identifying processing and staining problems on virtual images and working through the troubleshooting steps. The exercise also identified a method for troubleshooting formalin vapour-affected slides using citrate buffer which may be useful for laboratories following in-house validation.