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. Add any 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.


Information may include:
Equipment required
Packaging and label requirements
Preparation instructions
Raw drug materials list
Storage and stability data


Master sheet or formulae must:
Be clearly written
Be in logical order
Contain all required information
Contain no ambiguous directions


All materials used in manufacturing may be disposable or non-disposable and may include:
Automated compounding machines
Balances
Closing caps
Filters
Gauges
Meters
Mini spikes
Needles
Ointment slabs
Pumps
Spatulas
Syringes
Syringe connectors
Three way taps


Compound product may include:
Aggregation
Aseptic admixture
Aseptic transfer of materials from one vessel to another
Dilution
Dissolution
Mixing
Trituration


Pack product may include:
Bulk containers
Client ready units


Containers may include:
Eye droppers
Miscellaneous individual client unit devices
Small and large volume infusions bags
Syringes
Vials


Labels may be:
Electronically produced
Typed
Written


Storage conditions may include:
Ambient
Correct storage of hazardous substances
Correct temperature
Humidity
Isolated
Light
Secure and safe storage for controlled drugs
Secured
Ventilated


All required documentation may include:
Machinery and equipment logs
Machinery and equipment records


Destination may include:
Client care area
Dispensary
Store

EVIDENCE GUIDE

The evidence guide provides advice on assessment and must be read in conjunction with the Performance Criteria, Required Skills and Knowledge, the Range Statement and the Assessment Guidelines for this Training Package.

Critical aspects for assessment and evidence required to demonstrate this competency unit:
The individual being assessed must provide evidence of specified essential knowledge as well as skills
Observation of workplace performance is desirable for assessment of this unit
Consistency of performance should be demonstrated over the required range of situations relevant to the workplace
Where, for reasons of safety, space, or access to equipment and resources, assessment takes place away from the workplace, the assessment environment should represent workplace conditions as closely as possible


Context of and specific resources for assessment:
Simulations may be used to represent workplace conditions Acceptable simulation requires:
Scope to determine that work is conducted within legislative and regulatory requirements
Scope to determine that work is conducted within WHS and infection control requirements
Resources essential for assessment include:
Equipment that demonstrates an understanding of aseptic/cytotoxic production processes
Instructions on the use of equipment
Relevant legislation, regulations and guidelines
Relevant manufacturing and packing machinery
Weighing and measuring equipment
Note that assessment for this competency unit does not replace initial and ongoing formal validation processes required in the workplace to undertake aseptic or cytotoxic production (This usually requires the preparation and microbiological sampling of a number of prepared products for initial validation and at regular future intervals, as part of ongoing validation)


Method of assessment may include:
Formal appraisal systems
Interviewing and questioning
Observation in the work place (if possible) or simulated laminar flow hood/clean room or cytotoxic drug safety cabinet/cytotoxic suite or room
Supporting statement of supervisor(s)
Written assignments/projects, e.g. for fundamentals of microbiology and principles of cleaning and disinfection
Formal validation processes required in the workplace to undertake aseptic or cytotoxic production are outside the assessment for this competency unit.


Access and equity considerations:
All workers in the health industry should be aware of access and equity issues in relation to their own area of work
All workers should develop their ability to work in a culturally diverse environment
In recognition of particular health issues facing Aboriginal and Torres Strait Islander communities, workers should be aware of cultural, historical and current issues impacting on health of Aboriginal and Torres Strait Islander people
Assessors and trainers must take into account relevant access and equity issues, in particular relating to factors impacting on health of Aboriginal and/or Torres Strait Islander clients and communities