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Elements and Performance Criteria

  1. Interpret and schedule production requirements
  2. Work safely according to the legal and regulatory framework
  3. Assemble and maintain tissue culture equipment
  4. Prepare and test cell and tissue culture media
  5. Obtain, monitor and maintain tissue and cell lines
  6. Preserve cells and tissues
  7. Maintain records

Range Statement

This field allows for different work environments and conditions that may affect performance. Essential operating conditions that may be present (depending on the work situation, needs of the candidate, accessibility of the item, and local industry and regional contexts) are included.

Standards, codes, procedures and/or workplace requirements

Standards, codes, procedures and/or workplace requirements include the latest version of one or more of:

Australian and international standards covering the requirements for the competence of testing and calibration laboratories, laboratory safety, and quality and environmental management

Australian standards covering the requirements for cleaning, disinfecting and sterilising reusable medical and surgical instruments and equipment and maintenance of associated environments in health care facilities

national work health and safety (WHS) standards and codes of practice, national environmental protection measures, and national measurement regulations and guidelines

specific codes, guidelines and procedures, such as National Association of Testing Authorities (NATA) accreditation requirements, principles of good laboratory practice (GLP), Australia New Zealand Food Standards (ANZFS) Code, Australian code of good manufacturing practice for medicinal products (GMP), Therapeutic Goods Regulations, Australian Dangerous Goods Code, gene technology regulations, and Guide to physical containment levels and facility types

workplace documents, such as standard operating procedures (SOPs); quality and equipment manuals; calibration and maintenance schedules; material safety data sheets (MSDS) and safety procedures; material, client and product specifications; production and laboratory schedules; workplace recording and reporting procedures; and waste minimisation and safe disposal procedures

procedures and standard methods for preparing culture media, operation and maintenance manuals for automated media preparation equipment, and verified test methods

Cells and tissues

Cells and tissues include, but are not limited to, one or more of:

animal cell lines, such as hybridoma, liver, epidermal, lymphoblastic and fibroblastic

plant cell line,s such as tobacco, arabidopsis, soya bean, tomato, roses and meristomatic tissue

yeasts

fungi

sperm, ova and embryos

adherent and suspension cultures

Pre-use checks

Pre-use checks include:

performing routine maintenance

checks on raw materials and consumables, including use-by-date, and possible contamination and storage conditions

Preparing primary cultures

Preparing primary cultures includes, but is not limited to, one or more of:

thawing of cryopreserved cells and monitoring of cell recovery

enzymatic disaggregation from tissue

mechanical disaggregation from tissue

primary explant technique

pre-treatment

selection techniques, such as cloning, micromanipulation, use of selective media, density gradient centrifugation, selective adhesion techniques and selective detachment

Monitoring growth of tissue and cell lines

Monitoring growth of tissue and cell lines includes, but is not limited to, one or more of:

identification of normal and abnormal cells viewed using an inverted stereo microscope

recognition of contamination by cytopathic changes to cells, biochemical tests, gene detection and microbiological culture

testing for products, such as insulin

checking growth rates

performing viable cell counts, such as the dye exclusion test, and Trypan Blue viability stain to determine percentage viability and total cell concentration

staining and assessment of morphology (e.g. by Giemsa)

karyotype analysis

Workplace safety procedures

Workplace safety procedures include, but are not limited to, one or more of:

ensuring access to service shut-off points

recognising and observing hazard warnings and safety signs

labelling of samples, reagents, aliquoted samples and hazardous materials

handling and storage of hazardous materials and equipment in accordance with labelling, MSDS and manufacturer instructions

identifying and reporting operating problems or equipment malfunctions

cleaning and decontaminating equipment and work areas regularly using workplace procedures

using PPE, such as gloves, safety glasses, coveralls, gowns, body suits and respirators

using containment facilities (PCII, PCIII and PCIV physical containment laboratories), containment equipment (biohazard containers, laminar flow cabinets, Class I, II and III biohazard cabinets) and containment procedures

reporting abnormal emissions, discharges and airborne contaminants, such as noise, light, solids, liquids, water/wastewater, gases, smoke, vapour, fumes, odour and particulates, to appropriate personnel

WHS and environmental management requirements

WHS and environmental management requirements include:

· complying with WHS and environmental management requirements at all times, which may be imposed through state/territory or federal legislation. These requirements must not be compromised at any time

· applying standard precautions relating to the potentially hazardous nature of samples

accessing and applying current industry understanding of infection control issued by the National Health and Medical Research Council (NHMRC) and State and Territory Departments of Health, where relevant

Performance Evidence

Evidence of competence in this unit must satisfy all of the requirements of the elements and performance criteria, and include demonstration of:

safely preparing, maintaining and preserving cells and cell lines that are fit for purpose on at least three (3) different occasions

performing pre-use checks

preparing, diluting, sterilising and storing reagents and culture media that are fit for purpose

choosing and justifying appropriate media and substrate material based on cost, cleaning, sterilising and maintenance of cell growth

optimising equipment set-up, media and growth techniques

preparing primary cultures

passaging cell cultures by subculturing

growing and harvesting cell lines and tissue to specifications without contaminating the original sample or the environment

counting cells, identifying a wide range of cell types and contaminants and recognising normal and abnormal cells

monitoring growth of cells, tissue and cell lines

detecting and investigating contamination and taking preventative and corrective actions

storing cells so that they remain viable

preserving cell lines, including by freezing and cryopreservation (e.g. dry ice and liquid nitrogen)

maintaining accurate, traceable records of cell lines and tissues and logs of procedures and work completed

demonstrating chain of custody for all cells, cell lines and tissues

working safely and satisfying all legal and regulatory requirements, including the use and care of safety cabinets.

Knowledge Evidence

Must provide evidence that demonstrates knowledge of:

terminology, including cell lines, growth media, primary culture, passaging, passage number, subculture, anchorage dependent cells, suspension culture, monolayer, confluent, cell line, cell strain, contact inhibition, diploid and viability

cell biology, including structure, physiology, function, physiological cell growth requirements, nutrient requirements, respiration, temperature and growth cycle

purposes of cell lines

normal and abnormal cell morphology

critical components of the cell environment and their effects on cell growth, including pH, temperature, buffering, osmotic pressure, osmolarity, viscosity and foaming

types of tissue used as source material, including embryonic, adult or malignant tissue

techniques for characterising a cell line

selection criteria for media, materials and equipment, including:

costs

ease of cleaning or sterilisation

maintenance of cell growth

the differences between finite and continuous cell lines

characteristics of cell culture media and substrates

nature of substrates (e.g. solid, semi-solid, gel or sponge, glass, disposable plastics and three-dimensional matrices)

techniques for pre-treating substrates (e.g. feeder layers, chemical treatments, such as poly D-lysine, collagen, gelatine and fibronectin)

role of ingredients in media (e.g. salts, carbohydrates, amino acids, vitamins, hormones, growth factors, serum and antibiotics)

contaminants, including endotoxins, bacteria, yeast, fungi and Mycoplasma

typical requirements, problems and procedures associated with the production of specific cell lines

relevant hazards, work health and safety (WHS) and environment requirements.