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:

maintain material identity during storage

perform all manipulations safely

test stored material for reference characteristics before release

communicate appropriately with all customers.

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 any units that may involve using materials from a collection for example:

MSL916003A Supervise laboratory operations in work/functional area

MSL975001A Perform microbiological tests

MSL976003A Evaluate and select appropriate test methods and procedures.

Resources may include:

equipment and materials related to the occupational task for which the reference material is relevant

reference materials

standard operating procedures (SOPs).

Method of assessment

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 studies, 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

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 their relevance in a workplace setting.

Manufacturing

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.

Biomedical

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.

Food processing

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.

Required skills

Required skills include:

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

performing all manipulations safely

testing stored material for reference characteristics before release or use

communicating appropriately with all customers

Required knowledge

Required knowledge includes:

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:

Process manufacturing and construction:

drill (core) samples for mineral identification

concrete samples for analysis of composition and/or strength and suitability for application

Biomedical and environmental:

bacterial cultures related to colony and microscopic morphology, specificity and reliability of staining reaction, biochemical characteristics and 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

Food and beverage processing:

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 (e.g. barley varieties, such as Proctor, Franklin and Stirling)

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/NZS 2243 Set:2006 Safety in laboratories set

AS/NZS 4452:1997 The storage and handling of toxic substances

AS/NZS ISO 14000 Set:2005 Environmental management standards set

animal welfare legislation and codes of practice

Australian Dangerous Goods Code

Australian Quarantine and Inspection Service (AQIS) Export Control (Orders) Regulations 1982

Australian Quarantine and Inspection Service (AQIS) Import Guidelines

Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) Codes of Practice

cleaning, hygiene and personal hygiene requirements

enterprise procedures, standard operating procedures (SOPs) and operating manuals

gene technology regulations

incident and accident/injury reports

material safety data sheets (MSDS)

National Code of Practice for the labelling of workplace substances (NOHSC:2012 (1994))

national environment protection measures

National Health and Medical Research Council (NHMRC) Guidelines

national measurement regulations and guidelines

occupational health and safety (OHS) national standards and codes of practice

sampling procedures (labelling, preparation, storage, transport and disposal)

schematics, work flows and laboratory layouts

test procedures (validated and authorised)

Therapeutic Goods Regulations 1009

waste minimisation and disposal procedures

Reference materials

Reference materials may include:

specimens, such as cells, tissues and samples of aqueous or proteinaceous standards

aggregates, grains and powders

materials used for checking equipment calibrations

Dispensing and storing of reference materials

Dispensing and storing of reference materials may require:

reconstitution of completely lyophilised materials

preparing materials for freeze-drying

Equipment, materials and systems

Equipment, materials and systems may include:

centrifuges, water baths and 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

Communication

Communication may involve:

supervisors and managers (laboratory, quality and customer service)

other laboratory or clinical personnel

outside suppliers, internal and external customers

Hazards

Hazards may include:

chemicals, reagents

micro-organisms associated with soil, air, water, blood and blood products and human or animal tissue and fluids

sharps, such as broken glassware

disturbance or interruption of services

manual handling of heavy boxes

Safety procedures

Safety procedures may include:

use of personal protective equipment, such as hearing protection, gloves, safety glasses and coveralls

ensuring access to service shut-off points

handling and storing hazardous materials and equipment in accordance with labels, MSDS, manufacturer's instructions and enterprise procedures and regulations

regular cleaning of equipment and work areas

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