Abstract

Quality assured pathology services are integral to provision of optimal management for patients with head and neck cancer. Pathology services vary globally and are dependent on resources in terms of both laboratory provision and availability of a highly trained and accredited workforce. Ensuring a high-quality pathology service depends largely on close working and effective communication between the clinical team providing treatment and the pathologists providing laboratory input. Laboratory services should be quality assured by achieving external accreditation, most often by conforming to International Organization for Standardization (ISO) standards such as ISO15189 sometimes with ISO17025 or alternatively ISO17020. Quality of diagnostic reporting can be assured by the ISO but clinical teams should endeavor to work with pathologists who engage in continuing professional development, external quality assurance and audit. Research also contributes to diagnostic reporting quality. A number of initiatives in the UK such as the EPSRC/MRC funded Molecular Pathology Nodes and the National Cancer Research Institute Cellular-Molecular Pathology initiative (C-M Path), for example, have linked pathologists, industry and researchers. This has resulted in centers leading in digital innovation, artificial intelligence, translational research and clinical trials supported by pathologists. For rare tumors and contemporary molecular diagnostics, biopsy material can increasingly be shared with expert specialist pathologists working in specialist centers, particularly by using digital pathology platforms with potentially global reach. High quality services for the majority of diagnostic processes required for head and neck cancer management is best provided by local pathologists where communication with the treating team is more effective than with pathologists working in remote centers. Quality assurance is an increasingly important aspect of pathology, assuring not only effective turnaround times and accuracy for the diagnostic service but also high quality consistent reporting for clinical trials where even small pathology errors can potentially produce a significant bias and in the worst case negate the value of a completed trial. Better outcomes have been associated with centers engaged in clinical trials than in non-participating centers. Provision of a quality assured pathology service should extend to both the research and diagnostic services.

Highlights

  • Management of patients with head and neck cancer relies on accurate pathological diagnosis

  • The WHO Laboratory Quality Management System Handbook sets out international standards and brings together the key documents of the International Organization for Standardization (ISO) and the Clinical and Laboratory Standards Institute (CLSI)

  • The standards set out by CLSI are fully compatible with ISO and it is important for the clinical team to ensure that they work with a laboratory that is accredited by the International Organization for Standardization

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Summary

INTRODUCTION

Management of patients with head and neck cancer relies on accurate pathological diagnosis. Interpretation of pathology reports is further quality assured by clinical correlation and discussion at the multidisciplinary team meeting or tumor board. The standards set out by CLSI are fully compatible with ISO and it is important for the clinical team to ensure that they work with a laboratory that is accredited by the International Organization for Standardization. External Quality Assurance (EQA) plays an important role in driving quality improvement and maintaining a high-quality laboratory test repertoire and the interpretation of those tests by cytologists, pathologists and advanced practitioner biomedical staff. Standard Operating Procedures (SOPs) are used to document a series of detailed protocols and working procedures that can be followed by all of the laboratory staff so that a continuous quality service can be provided. The multi-disciplinary team meeting (MDTM) or tumor board should include pathologists as core members to facilitate effective communication and service improvements

QUALITY ASSURANCE IN THE LABORATORY
Description standard
QUALITY ASSURANCE FOR HEAD AND NECK PATHOLOGISTS
External Quality Assurance Schemes
Continuing Professional Development
Case Consensus Meetings
Patient Safety Systems
QUALITY ASSURANCE FOR DIGITAL PATHOLOGY
QUALITY ASSURANCE FOR CLINICAL
International Collaboration on Cancer Reporting
Staging and Diagnostic Entities
Findings
QUALITY ASSURANCE FOR MOLECULAR TESTING IN HEAD AND NECK PATHOLOGY
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