Elements and Performance Criteria

The range of variables relates to the unit of competency as a whole. It allows for different work environments and situations that will affect performance.
Where reference is made to industry Codes of Practice, and/or Australian/international standards, it is expected the latest version will be used.
All operations must comply with relevant regulations, Codes of Practice, standards, test methods and enterprise procedures.

These procedures include or have been prepared from
Australian and international standards, such as -
AS ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories
ISO 9000 series Quality management and quality assurance standards
AS/NZS 2243.3 Safety in laboratories Part 3 Microbiology - protective and physical containment facilities and equipment for safe handling of microorgansims and genetically modified organisms
SAA HB9 Occupational personal protection, and other relevant standards for protective, clothing (for example, AS 2161, AS 2210, AS 1337 and AS 1338)
AS 2252 Biological safety cabinets
AS 2830 Good laboratory practice
AS 2162.1 General - Volumetric glassware
AS 3753 Recommended practice for chemical analysis by ultraviolet/visible spectrophotometry

Other standards, guidelines and Codes of Practice, such as
National Association of Testing Authorities (NATA)
Good Laboratory Practice
Good Manufacturing Practice
National Registration Authority (NRA)
Therapeutic Goods Administration (TGA)
Australian Quarantine Inspection Service (AQIS)
Office of the Gene Technology Regulator (OGTR) guidelines for working with genetically altered organisms
guidelines for the operation of classes of laboratories
National Health and Medical Research Council (NHMRC)
European Union (EU)
World Health Organisation (WHO)
United States Food and Drug Administration (USFDA)
material safety data sheets (MSDSs)
validated and authorised test methods
quality manuals and equipment and procedure manuals
equipment start up, operation and shutdown procedures
calibration and maintenance schedules
production and laboratory schedules
material, production and product specifications.

Hazards may include
electric shock (for example, electrophoresis power packs)
microbiological organisms and agents associated with soil, air, water, blood and blood products, human or animal tissue and fluids
chemicals, such as acrylamide, temed, phenol, ammonium persulphate
mutagens, such as ethidium bromide, tumour promoters, cytotoxic materials
genetically altered organisms, transformed cultures and organisms
allergenic proteins
radioisotopes
transilluminators and other UV light sources
aerosols from broken centrifuge tubes, pipetting
sharps, broken glassware
flammable liquids and gases
cryogenics, such as dry ice and liquid nitrogen
disturbance or interruption of services.

Safe work practices and hazard control measures may include
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, materials safety data sheets and manufacturer's instructions
identifying and reporting operating problems or equipment malfunctions
cleaning and decontaminating equipment and work areas regularly using enterprise procedures
using personal protective clothing and equipment, such as gloves, safety glasses, coveralls, gown, body suits, 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/waste water, gases, smoke, vapour, fumes, odour and particulates to appropriate personnel.

Equipment and instrumentation may include
pipettes, tubes and racks
heating blocks, Polymerase Chain Reaction (PCR) thermal cyclers
swabs
centrifuges, shakers
electrophoresis tanks and power supplies
incubation cabinets for micro-organisms and cell culture
liquid nitrogen containers
autoclaves
water baths
waste containers
fume hoods
analytical instruments, such as spectrophotometers.

Reagents may include
DNA, RNA, proteins
enzymes - restriction, ligation, polymerisation
buffers
agarose, starch and polyacrylamide for electrophoresis gels
commercial kits for extraction and manipulation of DNA/RNA
phenol, chloroform
ethidium bromide
cell and culture media
DNA, protein stains
specialised probe materials, such as radioactive, chemical, chemiluminescent labels
blotting membranes
chromatographic media.

Molecular biology tests and procedures may include
generic skills, such as
sample digestion, extraction, filtration, separation, dialysis, precipitation and centrifugation.
accurate and reliable use of micropipettes
application of aseptic techniques
labelling (for example, digoxin, fluorescence, enzymes, radioactivity, antibodies)
production, labelling and use of DNA probes
preparation of competent bacterial cells
preservation and storage of samples (for example, freezing)
extraction of nucleic acids, such as-
isolation of genomic and plasmid DNA and RNA from samples, such as plants, bacterial suspensions, white blood cells, cheek cells, animal and plant tissue, cultured cells and forensic specimens
mini-prep and rapid method isolation of plasmid DNA
purification of nucleic acids and proteins, such as-
purification of DNA using cesium gradients, commercial purification buffer kits and columns
purification of recombinant protein by chromatography
production of nucleic acids, such as-
amplification of DNA by polymerase chain reaction
transformation with recombinant DNA
identification of transformed organisms with appropriate selection and analytical techniques, such as selective media and insertional inactivation
use of enzymes, such as-
storage and handling of enzymes taking into account segregation, temperature, buffers and labelling to avoid wastage, denaturation and contamination
ligation
assistance with analysis of nucleic acids and proteins, such as-
sequencing DNA
assaying of DNA purity and concentration using spectrometric analysis
electrophoresis of restriction enzyme digests of plasmid and genomic DNA using agarose gel
DNA sequencing by Sanger method
testing using restriction fragment length polymorphism (RFLP), probes, microsatellites
detection of protein products by measuring activity, including a range of immunological assays
assistance with hybridisations, such as-
hybridisation to screen cDNA libraries
blotting - southern blots for DNA, Western blots for protein
cloning, such as-
cloning and subcloning of genes and fragments of DNA
applications of techniques, such as-
PCR
methods to detect gene expression, such as RNA hybridisation, immunological techniques and radioactive labelling
testing DNA for sequence variation that is either causative of, or associated with, human disease
testing blood for the presence of viruses using the polymerase chain reaction
identification of species, such as bacterial contaminants
generating data for taxonomic and ecological investigations.
Corrective action may involve purification, dilution and/or additional extraction steps.

Records may include
test and calibration results
equipment use, maintenance and servicing history
photoimages of gels, radioisotopes, digital images
chain of custody from sample to result
supplier certificates of analysis
quality control/analysis data.

Health, safety and environment
All operations to which this unit applies are subject to stringent health, safety and environmental (HSE) requirements, which may be imposed through State or Federal legislation, and these must not be compromised at any time. Where there is an apparent conflict between performance criteria and HSE requirements, the HSE requirements take precedence.
All operations assume the potentially hazardous nature of samples and require standard precautions to be applied. Users should access and apply current industry understanding of infection control issued by the National Health and Medical Research Council and State and Territory Departments of Health. All operations are performed in accordance with standard operating procedures.

The Evidence Guide describes the underpinning knowledge and skills that must be demonstrated to prove competence.
Critical aspects of competency

Competency must be demonstrated in the ability to perform consistently at the required standard. In particular, assessors should look to see that the candidate:

conducts work practices in an ethical and professional manner and in accordance with relevant legislation, regulation and Codes of Practice
maintains security, integrity, traceability and identity of samples, sub-samples and work records
obtains purified biomolecules from samples
prevents/minimises DNA/RNA contamination
performs tests/procedures, such as PCR, ligation, restriction enzyme digestion with appropriate controls
follows enterprise safety standards, procedures and practices
follows enterprise procedures and test methods consistently and accurately
operates test equipment to enterprise standards and/or manufacturer's specification
identifies atypical results as out of normal range or an artefact
traces and sources obvious causes of artefacts
communicates identified problem(s) to a supervisor
records and communicates results as per enterprise procedures.

Underpinning knowledge

This competency includes the ability to apply and explain:

hazards and risks in molecular biology laboratories
common biotechnology terms

molecular biology principles and concepts underpinning tests/procedures, such as:

DNA and RNA structure and function
protein structure and function
relationship between chemical and physical properties of nucleic acids and proteins and the techniques used for sampling, preparation and testing
replication
transcription, translation and gene regulation
relationship between structure, organisation and function of biomolecules to the storage of information in cells, chromatin, circular and linear chromosomes, RNA, genes and plasmids
molecular genetics (molecular nature, organisation and function of genes)
molecular mechanisms of DNA mutation and variation
DNA transfer in prokaryotes (transformation, conjugation and transduction)
restriction enzyme and ligase structure, nomenclature, function, specificity and stability, cohesive vs blunt ends
ethical issues associated with biotechnology, such as-
use of animals for research
genetic modification of organisms and food
use of gene therapy, cloning, stem cells
in vitro fertilisation
forensic testing of populations
importance of commercial confidentiality, protection of intellectual property, patents
genetic screening of humans
sex determination and parentage testing of embryos/humans
importance and appropriate use of validation methods, controls and certified reference materials
enterprise and/or legal traceability requirements
relevant health, safety and environment requirements.

Assessment context and methods
This unit of competency is to be assessed in the workplace or simulated workplace environment.

The following assessment methods are suggested:

review of test records and workplace documentation completed by the candidate
review of results obtained by the candidate over a period of time to ensure accurate and consistent results are obtained within required timelines.
observation of candidate isolating, purifying, verifying and manipulating biomolecules
oral or written questioning
feedback from peers and supervisors.
In all cases, practical assessment should be supported by questions to assess underpinning knowledge and those aspects of competency which are difficult to assess directly. Questioning techniques should suit the language and literacy levels of the candidate.

Interdependent assessment of unit

This unit of competency may be assessed with:

PMLTEST409A Capture and manage scientific images
PMLTEST501B Perform microbiological tests
PMLTEST524A Apply routine spectrometric techniques
PMLTEST512A Apply electrophoretic techniques
PMLTEST513A Apply routine chromatographic techniques
PMLTEST517A Perform tissue and cell culture techniques.

Resource implications

Resources may include:

laboratory equipped with appropriate test equipment/instruments, standards and reagents
enterprise procedures, standard methods, manuals, supplier documentation.

This competency in practice
As part of a diagnostic service to verify progenitor status of livestock, a technician is required to extract DNA from a blood sample, perform the polymerase chain reaction to amplify micro-satellite DNA and prepare the sample for DNA electrophoresis and fragment size analysis. The technician provides documentation to meet evidentiary standards. The technician understands the implications of the tests for the client and is careful to ensure the sample can be traced from the source, that no contamination takes place and that the results are kept confidential.
A meat export company has commissioned a study of the effectiveness of the introduction of a 'cold-chain' process to a client country. The company requires rapid results. As part of the monitoring team, a technician is required to perform routine testing of surface swabs of meat samples for bacterial contamination using a Polymerase Chain Reaction (PCR) analytic technique. Although the tests are quite routine, the technician pays close attention to all aspects of the work as the consequences of invalid results would be severe for the company and laboratory. The technician also keeps comprehensive work records and maintains strict confidentiality.

The seven key competencies represent generic skills considered for effective work participation. The bracketed numbering against each of the key competencies indicates the performance level required in this unit. These are stand-alone levels and do not correspond to levels in the Australian Qualifications Framework (AQF).
Level (1) represents the competence to undertake tasks effectively
Level (2) represents the competence to manage tasks
Level (3) represents the competence to use concepts for evaluating and reshaping tasks.
Communicating ideas and information
(2)

Collecting analysing and organising information
(3)

Planning and organising activities
(2)

Working with others and in teams
(2)

Using mathematical ideas and techniques
(2)

Solving problems
(3)

Using technology
(2)