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.

Reference materials used in research and manufacturing processes could include
specimens, such as cells, tissues and samples of aqueous or proteinaceous standards
aggregates, grains and powders
materials used for checking equipment calibrations.

Information sources could include
enterprise procedures, standard operating procedures (SOPs) and operating manuals
test procedures (validated and authorised)
sampling procedures (labelling, preparation, storage, transport and disposal)
safety requirements for equipment, materials or products
cleaning, hygiene and personal hygiene requirements
quality system and continued improvement processes
incident and accident/injury reports
schematics, work flows and laboratory layouts
instructions to comply with new legislation, standards, guidelines and codes
waste minimisation and disposal procedures.

Equipment, materials and systems could include
centrifuges, waterbaths, incubators
lyophilisers and humidifiers
equipment and material for transport (such as dry ice or ice packs)
equipment and material for storage (such as liquid nitrogen)
storage boxes
storage and display cabinets
computer information systems, databases, record and filing systems
laboratory glassware and measuring equipment
materials suitable for the safe collection and disposal of biological and non- biological wastes.

This unit of competency may include communication with
supervisors and managers (laboratory, quality and customer service)
other laboratory or clinical personnel
outside suppliers, internal and external customers.

Hazards may include
chemicals, reagents
micro-organisms associated with soil, air, water, blood and blood products, human or animal tissue and fluids
sharps, such as broken glassware
disturbance or interruption of services
manual handling of heavy boxes.

Safety procedures may include
use of personal protective equipment, such as hearing protection, gloves, safety glasses, coveralls
ensuring access to service shut off points
handling and storing hazardous materials and equipment in accordance with labels, MSDS, manufacturer's instructions, enterprise procedures and regulations
regular cleaning of equipment and work areas.

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, and that materials and specimens are maintained so that the reference characteristics and attributes are stable in storage and manifest in use after retrieval.

In particular, the assessor should look to see that the candidate:

maintains material identity during storage
performs all manipulations safely
tests stored material for reference characteristics before release
reconstitutes completely lyophilised materials (if required)
prepares materials for freeze-drying (if required)
communicates appropriately with all customers.

Underpinning knowledge

Competency includes the ability to apply and explain:

certified reference materials - what they are, when and why they should be used
the storage requirements of biological and non-biological materials
quarantine or isolation procedures
the labile nature of chemical and biological materials
the rationale for testing reference characteristics before issuing reference materials
reasons for testing before accession of reference materials
relevant health, safety and environment requirements.

Specific industry

Additional knowledge requirements may apply for different industry sectors. For example:

drill (core) samples for mineral identification
concrete samples for analysis of composition and/or strength and suitability for application.
bacterial cultures related to colony and microscopic morphology; specificity and reliability of staining reaction; biochemical characteristics; immunological characteristics
cell suspensions and cell and tissue preparations that can act as quantitative or qualitative controls in tests and procedures
plasma and other body fluids with known attributes or quanta that can act as standards and controls in quantitative and qualitative tests and procedures
AQIS requirements for imported biologicals.
quality assurance for viability of enzymes used in process
bacterial or yeast cultures relating to colony and microscopic morphology for culturing purpose
grain samples used in identification of cereal specimens (for example, barley varieties, such as Proctor, Franklin and Stirling).

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 records for the supply of reference materials by the candidate
observation of the candidate performing tests of stored reference material prior to release and review of results

case study, such as the:

accession and processing of a plasma sample that is intended for use as a control in a blood coagulation test
response to request for supply of a Staphylococcus culture with coagulase activity
oral/written questioning about receipt, testing during storage and release of reference materials.
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:

any of the
PMLORG600B Supervise laboratory operations in work or functional area
PMLTEST603A Evaluate and select appropriate test methods and/or procedures.

Resource implications

Resources may include:

equipment and materials related to the occupational task for which the reference material is relevant
reference materials
standard operating procedures (SOPs).

This competency in practice
A technical officer in a pharmaceutical laboratory assays each batch of paracetamol tablets before their release for sale using ultraviolet spectrometric analysis. Twenty tablets are ground and a known weight of sample is dissolved in a specified solvent. The ultraviolet absorption is measured and compared with the absorption of a reference standard, which has been similarly treated. The potency of the tablets is calculated and compared to the release limits before being released for sale. The concentration of the reference paracetamol must be accurately known if the assay is to be correct. The standard is packed and stored under conditions that will minimise its breakdown, and the storage conditions are monitored to ensure that the potency remains with acceptable limits.
A technical officer in a histology laboratory was asked to perform a batch of iron stains by the Prussian Blue technique. The officer went to the block repository and chose one of the liver blocks known to contain haemosiderin. The officer checked the block number against the data in the control materials log and then cut four sections to process in parallel for the day's batch and those anticipated over the next few days. Noting that there was only one iron-positive block left, the officer wrote a short memo to the laboratory supervisor suggesting that the pathologist allow for a stock of tissue to be collected the next time they identified a suitable specimen.
While many attributes of food can be quantified and specified using chemical reference standards, some attributes are best assessed by comparison with a physical reference sample. For example, the number of poppy seeds on a loaf of bread would be impractical to count. However, comparison with retention samples made with various levels of poppy seeds will give an approximation of the number of seeds on the bread. Suitable reference samples need to be prepared and preserved so that the handling of samples does not result in seeds falling from the sample.

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
(2)

Planning and organising activities
(2)

Working with others and in teams
(2)

Using mathematical ideas and techniques
(2)

Solving problems
(2)

Using technology
(2)