The NZHSOA submitted the following paper entitled “A Scope of Practice for advanced scientific practice” to the Medical Science Council in Sept 2025.

A Scope of Practice for advanced scientific practice

Introduction

Healthcare advances when clinical practice embraces scientific innovation. This paper outlines the unique contributions of New Zealand Hospital Scientific Officers Association (NZHSOA) members and makes the case for a dedicated scope of practice that safeguards public health and recognises advanced scientific expertise. NZHSOA members operate at the interface between clinical demand and scientific capability. Pathologists provide clinical oversight of patient results, while MLS and Medical Laboratory Technicians (MLT) generally perform routine testing. Some scientists positioned between these groups design, validate, and interpret complex tests that are essential to modern healthcare. This work delivers significant clinical, social, and economic benefits while strengthening the resilience of the laboratory system. A clear example of this impact was during the COVID-19 emergency, when our members developed and implemented assays under extreme supply chain constraints. Beyond pandemic response, our expertise in technologies such as mass spectrometry, flow cytometry, next-generation sequencing, and bioinformatics ensures cost-effective use of resources and timely, accurate diagnoses. Laboratory-developed tests (LDTs) created in consultation with clinicians due to high clinical need are often more affordable and adaptable than commercial alternatives. In certain circumstances, there are no commercial alternatives to LDTs. LDTs support equitable access to diagnostics, maintain local expertise, reduce environmental waste, and minimise reliance on overseas services. Many LDTs also directly eliminate the need to send samples offshore, building domestic capability and allowing rapid clinical response. Through advanced practice members also contribute to research, publishing in peer-reviewed journals and disseminating knowledge nationally and internationally.

The need for a Dedicated Scope of Practice

The current MLS scope of practice does not adequately reflect the complexity, scale, or evolving impact of roles such as Research Fellows, Clinical Scientists, Scientific Officers, Section Heads, Technical Specialists, and Bioinformaticians who contribute at an advanced level. NZHSOA propose a more defined “fit-for-purpose” regulation, essential in protecting patients, whānau, and the wider health system, while ensuring the safe and ethical application of emerging technologies in patient focused care plans. A scope of practice that outlines competencies and responsibilities, recognising diverse career pathways is required. For example, data mining, digital pathology and artificial intelligence-driven technologies are skills the health service may require. An advanced scope of practice will allow the health system to adopt additional skills to meet the ever-increasing demand on health services. Recognition of scientists with advanced practice gained by qualifications and expertise, other than through the MLS route, is required. The creation of a new generation of laboratory professionals with a broad vision of health care and patient needs in a regulated advanced laboratory role, despite their potential to improve health equity and outcomes. The report recommended improvements to the integration of research into diagnostic laboratories. Similarly, precision health initiatives2 have highlighted the urgent need for new educational pathways and advanced scopes of practice.

Contributions by our members to Health Delivery Test Development

Practitioners with advanced skills design and validate clinically relevant, cost-effective tests, including:

Detection of psychoactive drugs for public health surveillance and emergency response.

Assays tracking bacterial resistance and viral genetic variation, ensuring tests remain clinically relevant during outbreaks.

Genetic testing for haemoglobinopathies, fibrinogen disorders, dysalbuminaemic hyperthyroxinaemia, and congenital glycosylation disorders.

Close collaboration with universities on cutting-edge therapies (e.g., monoclonal antibodies, CAR-T cells).

Development of bioinformatic pipelines for next-generation sequencing, variant curation, and integration of genomic data into clinical care.

Assays for somatic oncology, pharmacogenomics, and reproductive carrier screening.

Diagnostic algorithm design that integrates molecular, cytogenetic, and pathology data.

Application of artificial intelligence and machine learning to diagnostic workflows

National Services

Practitioners with advanced skills provide essential national services that are not deliverable in routine medical laboratories. These deliver cost savings and ensure equity, such as:

Functional cellular assays for diagnosing immunodeficiencies (predominantly for Starship Hospital).

National therapeutic drug monitoring for biologics used in inflammatory bowel disease, optimising treatment effectiveness while controlling costs.

National genomics services including cancer gene panels, germline sequencing, and exome/genome-based diagnostics.

National reference services in bioinformatics and variant classification frameworks.

Technology Integration

We lead implementation of emerging technologies and automation (e.g., mass spectrometry, next generation sequencing), enabling high-throughput, accurate testing while minimising error rates.

Clinical Consultation and Patient-focused care

We advise clinicians on test interpretation, assay precision, and the significance of results within clinical contexts, ensuring informed patient care.

Research and Innovation

Members collaborate with clinicians and health practitioners to conduct research, publish findings, and maintain strong academic and clinical networks. We contribute directly to national and international reference services, such as the WHO-accredited National Measles and Rubella Laboratory, and work with IANZ as technical experts in ISO accreditation audits.

Workforce Development and Policy

We train, mentor, and support the next generation of laboratory professionals, embedding Te Tiriti o Waitangi principles into practice. Members also contribute to international professional bodies (Human Genetics Society Australasia, The Royal College of Pathologist Australasia, Clinical Laboratory Standards Institute, Australasian Cytometry Society, Australasian Association for Clinical Biochemistry and Laboratory Medicine) to maintain global standards and ensure Aotearoa NZ remains aligned with best practice.

Suggested Competencies for an Advanced Scope

1. Scientific & Technical Leadership – Act as consultants and innovators, working autonomously and collaboratively with clinicians and other health practitioners to design, validate and interpret advanced diagnostic methods and/or perform specialised tests.

2. Test and Product Development – Lead new test/product development, operate as national reference centres, and ensure cost-effective diagnostic services. Develop and apply computational approaches ensuring reproducibility, data security, and clinical utility.

3. Service Maintenance and Compliance– Practice evidence-based medicine. Oversee test performance, investigate errors, apply statistical analysis, and maintain accreditation. Apply quality management system methodologies.

4. Clinical Consultation and Patient focused-care – Provide expert advice to clinicians on test regimes, expanding service scope, and quality assurance. Commitment to improve the health and wellbeing of all New Zealanders.

5. Promoting Excellence – Publish and disseminate expertise through peer-reviewed outputs and professional forums. Translate scientific advances into sustainable national services, supporting health equity and access across Aotearoa.

6. Education & Mentorship – Train clinicians, pathologists, registrars, and technical staff, ensuring cultural safety and respect for tikanga, ritenga, and mātauranga Māori.

7. Professional Service Development – Shape laboratory policy, standards, and professional practice nationally.

Qualifications

Entry to advanced scope to be competency-based. Typical qualifications include M.Sc., Ph.D., Fellowship of the Faculty of Science (RCPA), Fellowship of other relevant professional colleges, or equivalent specialist expertise (e.g., in bioinformatics, statistics, artificial intelligence, digital pathology or computational biology) with demonstrable impact on diagnostic services delivery, quality assurance, and clinical support. The capacity to work as an MLS is not diminished by an advanced scope of practice and vocational training is an important aspect of competence development. Evidence of expertise development is an iterative process, and practitioners attain competence through ongoing practice. The developed competencies may be assessed in the form of logbook, membership of professional bodies, or qualifications.

Title for a dedicated scope of practice

Suggested titles include Advanced Diagnostic Specialist, Specialists in Diagnostic Science, Specialists in Medical Laboratory Science, Healthcare Scientist, Higher Specialist Scientist, Specialist Medical Scientist.

Proposed Scope Wording

The scientist works at an advanced level of scientific and technical expertise. They lead in research, innovation, and diagnostic development, collaborating with clinicians, healthcare practitioners and laboratory staff to enhance patient care. Specialists are expected to:

Develop and refine analytical techniques.

Conduct and publish original research.

Teach and mentor staff, pathologists, registrars, scientists, and the public.

Contribute to service planning and strategic direction.

Model ethical practice in patient data use.

Specialists are accountable for ensuring services align with their competence, education, and legal obligations. Practitioners may have conditions limiting them to a defined area of practice.

Risks and Mitigation

Without an advanced scope of practice, risks include:

Service quality decline: Inconsistent standards in LDT development.

Public harm: Lack of accountability for complex testing.

Reduced innovation: Over-reliance on costly overseas services, delay in results, waste, and inefficiencies.

Workforce attrition and fragmentation: Loss of skilled scientists and difficulty attracting new recruits. Risk of siloing advanced scientists by title rather than by competencies.

Scope creep: confusion on roles of MLS and Pathologist in healthcare delivery.

Mitigation requires advanced scope regulation, ensuring practitioners:

Safeguard data integrity and patient safety3 .

Maintain Quality Management System compliance (ISO 15189).

Uphold Te Tiriti o Waitangi obligations and ethical frameworks.

Lead process improvements, audits, and validation of new devices and an agile response to emerging pathogens.

International practice alignment: development of an advanced scope of practice will align with comparable models in Australia and Europe where Clinical Scientists/Specialists in Laboratory Medicine are recognised on competency frameworks.

Roles and legislation

Across laboratories role names differ, for example at Canterbury Health Laboratory those with M.Sc./Ph.D are referred to as Scientific Officer and at Wellington Regional Genetics Laboratory those with B.Sc. in genetics are also called Scientific Officers. Similarly, the term Clinical Scientist is used in varying contexts. Practi tioners may hold a variety of job titles (e.g., Scientific Officer, Clinical Scientist, Bioinformatician, Section Head, Laboratory Director, Research Fellow, Technical Specialist) however a scope of scientific practice will unite these roles through their competencies ensuring accountability under the HPCA Act. The RCPA provides clear advice on the role of both a pathologist and a clinical scientist to minimise risk to patients in Australasia4 . The RCPA position aligns with Aotearoa NZ legislation (HPCA Act). Clarity on the scientific scope and title in relation to the pathologist’s role, irrespective of where one trained or practices, is required to protect the public.

Conclusion

A competency-based advanced scope of practice will provide a unifying framework across diverse roles. Regulating the competencies of advanced practitioners, who are integral to the future of New Zealand’s health service, will deliver clinical, operational, and strategic benefits, while strengthening equity and resilience. Establishing an advanced scope of practice will ensure consistent accountability to the HPCA Act, ensure patient safety and system accountability, drive innovation and cost savings, recognise and retain highly skilled professionals, enable recruitment of specialist skills within the laboratory workforce, facilitate career development pathways and future-proof medical diagnostic services for the benefit of all New Zealanders.

References

1 Hauora Haumi Allied Health Report 2024. https://www.health.govt.nz/system/files/2024-06/allied-healthreport-2024.pdf

2 Precision health: exploring opportunities and challenges to predict, prevent, diagnose, and treat health needs more precisely in Aotearoa New Zealand. 2023. https://www.health.govt.nz/system/files/2023-08/ltibprecision-health-online-version-v2.pdf

3 It was proposed under the Therapeutic Products Act (TPA) 2022 that LDT be developed by competent scientists registered to the HPCA Act. To align with the essential principles for the development of medical tests, LDT must also be performed in a quality management system compliant laboratory. In the absence of medical device regulation (the TPA was not enacted), the onus of public safety falls to the HPCA act. With the high usage of LDT in our tertiary laboratories consumer protection for results issued on these tests is required.

4 https://www.rcpa.edu.au/getattachment/aca09d06-db18-49b8-90c2-cf82d25bf0c4/The-Role-of-a-Pathology-Clinical-Scientist-in-Aust.aspx

*****************************************************************************************************************************************************************