Scope of Practice of the Scientific Workforce of the Laboratory

Pathology testing is a key medical service carried out at the request of doctors. Pathology laboratories are staffed by pathologists, senior scientists, scientists, technicians, technical assistants and other support staff. The production of timely and accurate results for referred patients requires the collaborative efforts of all laboratory staff. This document describes the Scope of Practice of scientific and technical staff.

The role that medically qualified pathologists play in supervising the cycle of patient care from test selection to reporting and interpreting results lies outside of the scope of this document.

Competency Based Standards

Competency Based Standards for Scientific Workforce of the Pathology Laboratory reflect the work performed by staff of different levels of qualification, skill, experience, responsibility and accountability.

The first six units are, by definition, general competencies whereas the last four represent advanced competencies expected of staff performing supervisory or management roles. It is intended that these standards be suitable for assessment of competency in a specific discipline or across several disciplines.

The units and elements in the Competency Based Standards form the structure for the Scope of Practice document. Together these documents will provide the basis for future certification of Medical Scientists (Pathology).

Competency Based Scope of Practice

Although the competencies in the document are initially described for Medical Scientist (Pathology), they are not specific for this group. Some competencies, such as clerical or technical work or interpretation, may be common to several different groups of staff, but can be practised at different levels or in different contexts. As a result, these same competencies may be applicable to all groups of staff in the scientific workforce of the pathology laboratory, commensurate with their position or role.

The Scope of Practice document (Appendix 1) seeks to break down the various units and elements described in the Competency Based Standards into laboratory related tasks. These tasks or competencies are colour coded for the minimum level or qualification of staff involved in performing them. As such the competencies are cumulative i.e. a scientist should be able to undertake duties which are assigned as a minimum level to laboratory assistants, technicians and scientists, but the degree to which these tasks are undertaken will depend on their role.

Details are shown in the table below.

Colour Minimum level of staff required to perform task

Yellow Laboratory Assistant Green Medical Technician (Pathology) Blue Medical Scientist (Pathology) Pink Senior Scientist

Page 1 of 19 Role Definition for Medical Scientists and Medical Technicians (Pathology)

It has become evident that role re-definition is required so scientific staff are removed from routine, and often more technical, testing. As such, their scientific skills could then be utilised in more complex testing, method or equipment validation or higher level roles involving supervision.

Definition of Technician

NPAAC defines a technician as a person with one of the following qualifications:

(i) associate degree or diploma as per Australian Qualifications Framework with subjects relevant to pathology or laboratory operations awarded by a recognised Australian TAFE or RTO (ii) qualification with subjects relevant to the field of pathology awarded by an overseas tertiary institution after not less than two years full-time study or an equivalent period of part-time study and where the qualification is recognised as equivalent to a diploma by the Australian Institute of Medical Scientists according to their authority approved by the Australian Education International-National Office of Overseas Skills Recognition with appropriate training and certified competencies to perform the functions required and who is authorised to perform this function by the Laboratory Director.

Definition of Scientist

If the scientific and, consequently, laboratory technical roles are being redefined, it is timely to review the definition of a Medical Scientist (Pathology).

Review of requirements by societies and associations show diversity in requirements for a scientist. These various requirements are detailed below:

Australian Institute of Medical Scientists (AIMS) defines a scientist as:

one who has completed an AIMS accredited degree or an acceptable science degree (which includes full units of human anatomy, human physiology, chemistry, biochemistry, , general , general pathology, human molecular biology and at least two of the subjects , haematology, , transfusion science and /diagnostic cytology).

To be a Graduate Member of AIMS, the individual needs to hold an AIMS accredited qualification.

To be a Professional Member of AIMS the individual needs to hold one of the above qualifications and a minimum of two years post graduate professional experience in an approved diagnostic medical laboratory, OR be a graduate of a relevant science degree course that meets AIMS requirements in the subjects studied and have completed two years postgraduate professional experience in a diagnostic medical laboratory and have successfully completed the AIMS Professional Examination.

According to the Australian Society of Cytology (ASC), NPAAC requirements for Gynaecological (cervical) Cytology 2006 state (footnote 2):

"Appropriate training for scientists is defined as having a relevant degree in science or applied science together with a minimum of two years full-time training/experience in NATA/RCPA accredited laboratory for gynaecological cytology. A senior cytotechnologist is

Page 2 of 19 a person having the equivalent of five full-time years experience in cytology and holding a qualification which designates competence in cytology."

Human Genetics Society of Australasia (HGSA) requires ordinary Members shall be such persons who:

(i) Hold a relevant degree or professional qualification from an Australasian university or other institution, or an equivalent degree or qualification from a non-Australasian country; and

(ii) (a) Whose primary vocation involves or has involved, significant clinical, laboratory, administrative, or other professional responsibility in the clinical care, diagnosis, or management of individuals or families with genetic or developmental conditions; or

(b) Whose primary vocation is, or has been, research, education or administration related to Human Genetics

Associate members of Australasian Association of Clinical (AACB) must possess a degree from an approved University or an equivalent tertiary qualification.

Australian Society of Microbiology (ASM) professional class of membership (Member of the Australian Society for Microbiology) requires:

(i) Completion of requirements of an academic qualification in microbiology at degree level or alternative qualifications acceptable to National Council; AND (ii) Completion of two years of post graduate full-time employment, or its equivalent, as a practising microbiologist

Definition of Senior Scientist

NPAAC ‘Requirements for the Supervision of Pathology Laboratories’ defines a senior scientist as a “scientist who has had not less than 10 years full-time relevant laboratory experience and who possesses one of the following qualifications:

(a) a Doctorate of Philosophy in a subject relevant to the field of pathology (b) a Fellowship of the Australasian Association of Clinical Biochemists (c) a Fellowship of the Australian Institute of Medical Scientists (d) a Fellowship of the Australian Society for Microbiology (medical/clinical microbiology) (e) a Fellowship of the Human Genetics Society of Australasia (f) a qualification that the Minister determines, pursuant to the definition of ‘scientist’ in subsection 23DNA(4) of the Act 1973, to be equivalent to a qualification referred to in paragraph (a), (b), (c), (d), or (e) of this definition.”

It is envisaged that a senior scientist will play a senior role in the functioning of a pathology laboratory and will be involved in tasks such as creation of assays and research and development in both analytical and clinical sense.

Page 3 of 19 References:

Competency-based Standards for Medical Scientists, Commonwealth of Australia, 1993 http://www.aims.org.au/c/uploads/documents/cbs.pdf

The Australian Pathology Workforce Crisis, Michael Legg and Associates, Department of Health and Ageing, October 2008 http://www.health.gov.au/internet/main/publishing.nsf/Content/health-patholreport-wforceoct08.htm

US Bureau of Labor Statistics Occupational Outlook Handbook (OOH), 2008-09 edition (2010-11 edition) http://www.bls.gov/oco/ocos096.htm

A career framework for Healthcare Scientists in the NHS, Department of Health, November 2005 http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_412320 5

Code of Competencies and Standards for the Practice of Medical Laboratory Science, Medical Laboratory Science Board, New Zealand http://www.mlsboard.org.nz/assets_mlsb/Uploads/Documents/Code-of-Competencies-and-Standards.pdf

D.Harmening, B.Castleberry and M.Lunz, Defining the Roles of Medical Technologists and Medical Laboratory Technicians, Laboratory , Volume 26, Number 3, March 1995

Standards of Proficiency – Biomedical Scientists, Health Professions Council, effective 1 November 2007 http://www.hpc-uk.org/assets/documents/100004FDStandards_of_Proficiency_Biomedical_Scientists.pdf

Path-West Workforce Report, Department of Health, Government of Western Australia, Metropolitan Health Service, June 2008 http://www.pathwest.com.au/pdf/PATHWEST%20WORKFORCE%20REPORT.pdf

Competencies Expected of an entry-level Medical Laboratory Technologist, Canadian Society for Medical Laboratory Science, May 2005 http://www.csmls.org/english/pdf/student/general_medical_laboratory_technology_competency_profile_2010 .pdf

Page 4 of 19 Appendix 1:

Scope of Practice

Laboratory Technician and Scientist and Assistant and above above Senior Scientist above

Technical Skills

* Collection, preparation and analysis of clinical material

Understands Aware of Understands transport collection correct requirements for 1.1 Ensure the instructions for identification and test and notifies appropriateness of test procedure/s labelling appropriate staff sample collection and correct requirements for if this is procedures specimen/s patient exceeded and/or required for specimens results are testing compromised

Aware of Notifies requirements to appropriate staff Determines 1.2 Ensure the match specimen if patient acceptability of appropriateness of and identification samples within specimen reception documentation error is observed established procedures upon receipt in or specimen is guidelines laboratory sub-optimal

Page 5 of 19 Determines acceptability of 1.3 Evaluate samples using specimen suitability established prior to analysis protocols and guidelines

Ensures quality and timeliness of

patient test Prioritises Coordinates results by 1.4 Determine the assignment of general workflow investigating priority of laboratory test requests and reorganises problems requests (triage) to according to to suit changes involving effectively manage established in priority specimen service requirements guidelines collection, result reporting and turnaround time

Performs Performs some Performs Operates Performs quality Troubleshoots preventative and non-automated Performs some Recognises standard Determines 1.5 Process Prepares laboratory control instrument corrective and automated non-automated appropriate and laboratory when "backup" specimen utilising specimens for instruments procedures using problems using maintenance laboratory and specialised inappropriate techniques methods must appropriate analysis appropriate to established established and repairs on techniques laboratory selection of all under be initiated techniques role protocols procedures laboratory appropriate to procedures lab tests supervision equipment role appropriate to role

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Evaluates and calculates

Evaluates quality quality control Where Performs Where Uses statistical control measures statistics to necessary, preliminary necessary, methods to and institutes assess enters results evaluation of records research and 1.6 Read and appropriate accuracy, and quality quality control observations assess validate results corrective action reproducibility control data and refers data and details laboratory within established and validity of according to to scientific staff according to testing laboratory regulatory guidelines current protocols requirements laboratory methods

Knowledge Base

* Correlation and validation of results of investigations using knowledge of method(s) including analytical principles and clinical information

Identifies

technical, Develops Understands the Recognises and instrumental, solutions to Demonstrates 2.1 Assess validity of Recognises and basic physiology refers and/or problems based high level of data / results against refers abnormal behind implausible physiologic on knowledge, clinical and possible range of results laboratory results causes of patient scientific outcomes results unexpected test diagnosis and expertise results instrument performance

Reports Evaluates and abnormal results interprets test within position Has knowledge 2.2 Perform results within requirements of the theory of validation of results position and seeks laboratory requirements advice when procedures necessary

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2.3 Make decisions Recognises and Differentiates Correlates Integrates and about reporting refers results technical, Recognises abnormal relates lab data Recognises and results, repeating when necessary instrumental appropriate and laboratory data generated by refers questions Refers requests procedures, and follows and/or inappropriate with pathologic various lab and/or problems for special and consulting senior documented physiologic selection of states to sections in to appropriate unusual tests staff and carrying out procedure in causes for basic laboratory determine making personnel further tests within dealing with unexpected test testing validity and/or judgements established rejected results results whether follow- regarding guidelines up tests should possible be done discrepancies

Analytical / Decision Making

* Interpretation, reporting and issue of laboratory results

Ensures patient Deals with Reports test identification is inconsistency in 3.1 Verify report(s) results traceable at all sample with sample appropriate to steps of testing identification identification role process appropriately

Follows procedures to

3.2 Use the Observes ensure Identifies and administrative principles of data communication follows up systems in place to security / patient of results occurs overdue results communicate the confidentiality in timely manner results and this process is documented

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Ensures reference Interacts with

intervals and/or Ensures accurate other health 3.3 Ensure that Works with reported advice is care workers to Informs results with important Recognises Performs Pathologists to Creates an comments on communicated solve problems diagnostic or significant analytical and establish critical- evidence base results are where necessary and interpret concerning treatment results and decision-making level values and for use by communicated and this is patient lab details and implications are alerts functions under develop clinicians for where necessary documented results within limitations of lab communicated as appropriate staff supervision acceptable the benefit of and this is according to the framework procedures per established criteria patients protocols documented procedures of medical according to science procedures

Ensures reports

are disposed Ensures results Ensures results according to Analyses and/or reports 3.4 Ensure are recorded regulatory laboratory are stored appropriate storage according to requirements computer according to and disposal of data regulatory and ensuring applications to regulatory and reports requirements privacy and manage data requirements confidentiality is maintained

Resource Maintenance

* Maintenance of documentation, equipment, resources and stock

Maintains adequate stocks of and

Ensures blood products Ensures stock Disposes Determines quarantine of according to Maintains received is expired or quantities of 4.1 Coordinate expired or pre-determined inventory and transported and dangerous blood and blood supplies of stocks contaminated stock levels and supplies subsequently goods according products to be and reagents stock to prevent defers any stored according to regulations held by to manufacturers inadvertent use issues with laboratory specifications supply to senior staff member as required

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Ensures safety Performs Calibrates protocols for preventative and laboratory equipment are Ensures proper corrective instruments 4.2 Participate in maintained and functioning of maintenance within maintenance of the risk assessments laboratory and repairs on requirements of laboratory and are performed if equipment basic laboratory position to equipment deviation to equipment ensure accuracy normal safety protocols

Creates analytically valid

Consults with and traceable Maintains Writes relevant Follows relevant Appropriately routine assays, 4.3 Participate in records / procedures personnel guidelines for communicates underpinned by Approves new preparation and documentation according to regarding need method / manual changes to all reference methods as fit for revision of manuals and monitors for prescribed for change to content relevant staff materials and use and protocols any updates format documentation methods in order to measure entities appropriately

Involved in

appropriate Communicates Suggests cost utilisation of 4.4 Ensure requirements for effective human and appropriate laboratory laboratory technical resources are resources to procedures or resources, available to the appropriate protocol including laboratory personnel position descriptions

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Safety

* Maintenance and promotion of safe working practices

Maintains inventory of hazardous Prepares, labels, reagents 5.1 Prepare and handles and including MSDS store reagents and stores reagents and reviews solutions according to periodically to requirements ensure substances no longer in use are discarded appropriately

Ensures procedures do not contain

5.2 Identify and unsafe practice Complies with respond to unsafe and notifies and promotes work practices and appropriate safety guidelines breaches of personnel with regulations concerns or improvement suggestions

Adheres to

5.3 Ensure correct appropriate Ensures receipt, Ensures procedures are safety despatch from protocols for followed for regulations and Holds appropriate laboratory and handling of Develops safety acquisition, is responsible to licence for disposal of dealing with Enforces safety and waste collection, storage, community and handling biological, toxic spills of regulations management transportation and environment radioactive or radioactive biological, toxic procedures disposal of when handling substances substances is or radioactive biological, toxic and and/or disposing according to substances are radioactive wastes of hazardous guidelines followed substances

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Familiar with Aware of safety Documents hazards caused 5.4 Respond documentation safety related by interaction of appropriately to and use of incidents some emergency situations safety according to substances equipment protocol

Professional Development

* Professional accountability and participation in continuing professional development

Displays interest

6.1 Establish and and participates Identifies and Assists with communicate in departmental Responsible for discusses goals professional personal goals in education own professional for professional development of professional commensurate development development staff development with level of training

Updates knowledge by attending 6.2 Maintain and relevant update scientific / meetings, technical knowledge reviewing and skills scientific and technical literature and case studies

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Demonstrates Volunteers for Develops understanding of additional duties additional skills Researches and laboratory Develops and 6.3 Develop skills and shows by participating develops the operations and utilises research relevant to the initiative in in relevant field of analysis place of skills enhancement of suggesting activities or both analytically laboratories in professional growth improvements attending and clinically health care approved courses

Undertakes work Identifies Intervenes, and gives unprofessional where guidance and conduct and applicable, to Consults with Sets an example 6.4 Recognise own advice within reports serious ensure rights senior staff when to others in the abilities and level of bounds of one's breaches to and/or safety of necessary workplace professional abilities, appropriate person/s in the competence qualifications authorities workplace and training

Maintains ethical Exercises standards and professional displays Maintains judgement, skill 6.5 Comply with professional confidentiality and care in profession’s code of conduct in a and professional decisions made ethics non- competence regarding discriminatory patients and manner others

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Accountability

* Responsibility for Medical Science practice including test selection, development and use of laboratory investigations

Delegates tasks Able to make (or enlists help appropriate of others) and decisions ensures 7.1 Accept commensurate appropriate responsibility for own with level of completion of actions / omissions experience these, and/or job commensurate description with role and ability

Applies step-by- step thinking, Contributes to Demonstrates responsibility problem solving Performs resolution of Responsible for 7.2 Make Supervises and and critical analytical and conflicting or contributes to independent, laboratory accountability thinking patterns decision making decisions / strategic professional personnel as for management and is aware of functions without interpretations direction of judgements assigned and planning of implications supervision within the laboratory associated with laboratory services and/or outcomes departments

Considers ethics 7.3 Demonstrate Respects the within laboratory Refers ethical knowledge of rights of environment problems in the contemporary ethical individuals or relating to data, workplace to a issues impinging on groups in the events or higher authority Medical Science workplace business relationships

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Reviews current literature relating Possesses to new or Identifies tests / Demonstrates 7.4 Demonstrate scientific improved parameters Performs new Evaluates and Develops and innovation and knowledge of new knowledge to procedures and which help procedures as validates new implements new highly developed tests and their evaluate clinical makes diagnose, screen directed methodologies tests as required and specialised potential in the laboratory recommendations and monitor skills laboratory technology for adoption treatment where appropriate

Communication

* Liaison with health workers and others to continuously improve the service

Documents Performs quality Identifies and Audits clinical 8.1 Participate in issues and assurance Monitors quality suggests Continuously use, general quality improvement refers these to relevant to assurance standards of improve quality guidelines and activities senior staff laboratory role practice to meet goals promulgates best practice

Implements 8.2 Continually Suggests cost changes in review laboratory effective response to processes and laboratory technology and testing to streamline, procedures or laboratory minimise waste and protocol increase efficiency procedures

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Assists in Assists in establishing and establishing 8.3 Establish and maintaining service level for maintain appropriate suppliers and relationships with communication documents and suppliers with internal and refers any failure external of this to senior suppliers staff

Demonstrates Communicates awareness of 8.4 Establish and and maintains key performance maintain confidentiality in indicators to relationships with relation to ensure service users service delivery laboratory meets clients needs

Education / Training

* Participation in education and training of health workers and others

Prepares and 9.1 Research, delivers training prepare and deliver and/or appropriate presentations presentations to relevant to peers in-house or position as externally required

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Prepares and presents 9.2 Participate in continuing interdepartmental education and other meetings lectures and conferences for personnel

Provides 9.3 Where Responds to Provides advice instruction on appropriate, provide technical on interpretation collection and/or instruction on questions and significance testing of collection, testing of consistent with of results, giving specimens specimens, level of training, consideration to commensurate interpretation and knowledge clinical with experience significance of and/or information and and results and service qualifications limitations of test delivery qualifications

9.4 Train personnel Teaches theory Instructs in the operation of and procedures patients, new instruments and using technicians, Trains staff Instructs Trains laboratory equipment, the educational medical commensurate personnel in personnel in new performance of methodology students, with experience work group on technology and methods and quality and establishes residents and and new methods / laboratory control procedures, feedback to peers regarding qualifications instruments procedures patient monitor laboratory confidentiality, and effectiveness of testing as the observation of training required safety measures

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Research and Development

* Contribution to advancement of knowledge and improvement of laboratory practice

Identifies issues Assists with Accesses Understands 10.1 Contribute to and design of the appropriate ethics and May initiate or planning and communicates project within information protocols lead formal design of research research idea to position related to the associated with research and development appropriate requirements project research projects projects personnel

Follows Assesses and 10.2 Follow procedures and assembles research / monitors and resources for development documents project protocol outcomes

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Assists in

Collects, determining Assists in Evaluates and analyses data requirements for 10.3 Evaluate evaluation and validates new and contributes further research results and the selection of new methodologies to interpretation in consultation need for further equipment experimental work of results with appropriate personnel

Prepares and reviews reports 10.4 Prepare and (written, verbal, deliver report journal) and submits for peer review

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