Elements and Performance Criteria

RANGE STATEMENT
The range statement relates to the unit of competency as a whole. It allows for different work environments and situations that may affect performance. Bold italicised wording, if used in the performance criteria, is detailed below. Essential operating conditions that may be present with training and assessment (depending on the work situation, needs of the candidate, accessibility of the item, and local industry and regional contexts) may also be included.
Codes of practice
Where reference is made to industry codes of practice, and/or Australian/international standards, it is expected the latest version will be used
Standards, codes, procedures and/or enterprise requirements
Standards, codes, procedures and/or enterprise requirements may include:
Australian and international standards, such as:
AS 2162.1-1996 Verification and use of volumetric apparatus - General - Volumetric glassware
AS 2252 Biological safety cabinets
AS 3753-2001 Recommended practice for chemical analysis by ultraviolet/visible spectrophotometry
AS ISO 17025-2005 General requirements for the competence of testing and calibration laboratories
AS/NZS 1269 Set:2005 Occupational noise management set
AS/NZS 1337 Eye protection
AS/NZS 2161 Set:2008 Occupational protective gloves set
AS/NZS 2210:1994 Occupational protective footwear
AS/NZS 2243.3:2002 Safety in laboratories - Microbiological aspects and containment facilities
AS/NZS 4501 Set:2008 Occupational clothing set
HB 9-1994 Occupational personal protection
Australian code of good manufacturing practice for medicinal products (GMP)
calibration and maintenance schedules
cleaning, hygiene, personal hygiene requirements
enterprise procedures, standard operating procedures (SOPs) and operating manuals
equipment startup, operation and shutdown procedures
European Union (EU)
Guide to physical containment levels and facility types
guidelines for small scale genetic manipulation work from the gene technology regulations
incident and accident/injury reports
instructions to comply with new legislation, standards, guidelines and codes
material, production and product specifications
National Association of Testing Authorities (NATA) Accreditation programs requirements
National Health and Medical Research Council (NHMRC)
National Registration Authority (NRA)
principles of good laboratory practice (GLP)
production and laboratory schedules
quality manuals and equipment and procedure manuals
quality system and continued improvement processes
safety requirements for equipment, materials or products and material safety data sheets (MSDS)
sampling procedures (labelling, preparation, storage, transport and disposal)
schematics, work flows and laboratory layouts
test procedures (validated and authorised)
Therapeutic Goods Regulations 1009
United States Food and Drug Administration (USFDA)
validated and authorised test methods
waste minimisation, containment, processing and disposal procedures
World Health Organisation (WHO)
Hazards
Hazards may include:
electric shock (e.g. electrophoresis power packs)
microbiological organisms and agents associated with soil, air, water, blood and blood products, and human or animal tissue and fluids
chemicals, such as acrylamide, temed, phenol and ammonium persulphate
mutagens, such as ethidium bromide, tumour promoters and cytotoxic materials
genetically altered organisms, transformed cultures and organisms
allergenic proteins
radioisotopes
transilluminators and other ultraviolet (UV) light sources
aerosols from broken centrifuge tubes and pipetting
sharps and 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
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, MSDS 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, 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/waste water, gases, smoke, vapour, fumes, odour and particulates to appropriate personnel
Equipment and instrumentation
Equipment and instrumentation may include:
pipettes, tubes and racks
heating blocks and polymerase chain reaction (PCR) thermal cyclers
swabs
centrifuges and shakers
electrophoresis tanks and power supplies
incubation cabinets for micro-organisms and cell culture
liquid nitrogen containers
autoclaves
water baths
waste containers
fumehoods
analytical instruments, such as spectrophotometers
Reagents
Reagents may include:
DNA, RNA and proteins
enzymes (restriction, ligation and polymerisation)
buffers
agarose, starch and polyacrylamide for electrophoresis gels
commercial kits for extraction and manipulation of DNA/RNA
phenol and chloroform
ethidium bromide
cell and culture media
DNA, and protein stains
specialised probe materials, such as radioactive, chemical and chemiluminescent labels
blotting membranes
chromatographic media
Molecular biology tests and procedures
Molecular biology tests and procedures may include:
generic skills:
sample digestion, extraction, filtration, separation, dialysis, precipitation and centrifugation
accurate and reliable use of micropipettes
application of aseptic techniques
labelling (e.g. digoxin, fluorescence, enzymes, radioactivity and antibodies)
production, labelling and use of DNA probes
preparation of competent bacterial cells
preservation and storage of samples (e.g. freezing)
extraction of nucleic acids:
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:
purification of DNA using cesium gradients, commercial purification buffer kits and columns
purification of recombinant protein by chromatography
production of nucleic acids:
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:
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:
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 and microsatellites
detection of protein products by measuring activity, including a range of immunological assays
assistance with hybridisations:
hybridisation to screen cDNA libraries
blotting (southern blots for DNA and Western blots for protein)
cloning:
cloning and sub-cloning of genes and fragments of DNA
applications of techniques:
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
Corrective action may involve:
purification
dilution
additional extraction steps
Records
Records may include:
test and calibration results
equipment use, maintenance and servicing history
photo images of gels, radioisotopes and digital images
chain of custody from sample to result
supplier certificates of analysis
quality control/analysis data
Occupational health and safety (OHS) and environmental management requirements
OHS and environmental management requirements:
all operations must comply with enterprise OHS and environmental management requirements, which may be imposed through state/territory or federal legislation - these requirements must not be compromised at any time
all operations assume the potentially hazardous nature of samples and require standard precautions to be applied
where relevant, users should access and apply current industry understanding of infection control issued by the National Health and Medical Research Council (NHMRC) and State and Territory Departments of Health

EVIDENCE GUIDE
The Evidence Guide provides advice on assessment and must be read in conjunction with the performance criteria, required skills and knowledge, range statement and the Assessment Guidelines for the Training Package.

Overview of assessment

Critical aspects for assessment and evidence required to demonstrate competency in this unit
Assessors should ensure that candidates can:
conduct work practices in an ethical and professional manner and in accordance with relevant legislation, regulation and codes of practice
maintain security, integrity, traceability and identity of samples, sub-samples and work records
obtain purified biomolecules from samples
prevent/minimise DNA/RNA contamination
perform tests/procedures, such as PCR, ligation and restriction enzyme digestion with appropriate controls
follow enterprise safety standards, procedures and practices
follow enterprise procedures and test methods consistently and accurately
operate test equipment to enterprise standards and/or manufacturer's specification
identify atypical results as out of normal range or an artefact
trace and source obvious causes of artefacts
communicate identified problems to a supervisor
record and communicate results as per enterprise procedures.

Context of and specific resources for assessment
This unit of competency is to be assessed in the workplace or simulated workplace environment.
This unit of competency may be assessed with:
MSL974008A Capture and manage scientific images
MSL975001A Perform microbiological tests
MSL975008A Apply electrophoretic techniques
MSL975009A Apply routine chromatographic techniques
MSL975013A Perform tissue and cell culture techniques
MSL975020A Apply routine spectrometric techniques.
Resources may include:
laboratory equipped with appropriate test equipment/instruments, standards and reagents
enterprise procedures, standard methods, manuals and supplier documentation.

Method of assessment
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.
Where applicable, reasonable adjustment must be made to work environments and training situations to accommodate ethnicity, age, gender, demographics and disability.
Access must be provided to appropriate learning and/or assessment support when required.
The language, literacy and numeracy demands of assessment should not be greater than those required to undertake the unit of competency in a work like environment.

This competency in practice
Industry representatives have provided the case studies below to illustrate the practical application of this unit of competency and to show its relevance in a workplace setting.
Biomedical
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 PCR 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.
Food processing
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 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.