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 essential 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:

Assessment should replicate workplace conditions as far as possible. It may be necessary to undertake the assessment in another workplace or hospital that has the required facilities

Simulations may be used to represent workplace conditions as closely as possible
Acceptable simulation requires:

Scope to determine that work is conducted within legislative and regulatory requirements

Scope to determine that work is conducted within OHS and infection control requirements

Resources essential for assessment include:

Access to relevant workplace or appropriately simulated environment where assessment can take place

Relevant legislation, regulations and guidelines

Weighing and measuring equipment

Relevant manufacturing and packing machinery

Instructions on the use of equipment

Aseptic/cytotoxic facilities

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:

Observation in the work place (if possible)

Written assignments/projects, eg for fundamentals of microbiology and principles of cleaning and disinfection

Interviewing and questioning

Formal appraisal systems

Supporting statement of supervisor(s)

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

This describes the essential skills and knowledge and their level required for this unit.

Essential knowledge:

Basic hygiene and the importance of maintaining a clean working environment and equipment

Calculations and content rationale for all sterile admixtures

Chemical and physical properties of materials in relation to formulation and compounding

Circumstances requiring sterile medication

Correct disposal of sharps, drug residues, cytotoxics etc.

Cytotoxic use and therapeutic effect

Different types of filters/compatibility of filters with pharmaceutical products.

Hazards related to cytotoxic manufacture

Identification of the circumstances that require compounding of the product within a laminar flow hood / clean room or cytotoxic drug safety cabinet / cytotoxic suite or room or isolator.

Identification and handling of products, including

formulary drugs and non-formulary drugs eg clinical trial drugs and special access scheme drugs

products with the required integrity as well as those whose integrity has been compromised eg damaged, contaminated or deteriorated stock

routine handling of products and products requiring special handling, eg cytotoxics and its spill management, refrigerated and frozen items, light sensitive materials and flammables

Infection control policies, guidelines and symbols and their relevance to working in a hospital pharmacy

Knowledge of and the rationale for applicable legislation, organisation policy and in-house standard operating procedures (SOPs), relating to the small scale manufacture of aseptic pharmaceutical products, including cytotoxic products

Maintenance principles and procedures of clean work environments

Management of cytotoxic spills

Nature and use of different dosage forms

OHS policies, guidelines and symbols and their relevance to working in a hospital pharmacy

Packaging methods, container materials and principles for selection

Personal hygiene and clothing standards for manufacture

Pharmacy computer systems

Preparation of worksheets

Principles and procedures of formulae calculations, weights and measures

Principles and procedures of maintaining security of pharmaceutical products

continued ...

Essential knowledge (contd):

Principles of aseptic technique and cytotoxic manufacturing aseptic technique

Principles of handling and storage of hazardous materials

Principles of record keeping

Processes for dilution, suspension, incorporation and reconstitution

Purpose of batch numbering and expiry date on medicines

Purpose of information to be shown on medicine packs, eg product name, batch numbering and expiry date Basic principles of manufacturing processes

Sources and types of contamination - microbial, cross-chemical, physical, environmental and corrective strategies

Specific labelling requirements for aseptically prepared products

Sterilisation of pharmaceuticals, use of terminal filtration

Storage requirements and rationale for different types of product

Transport of cytotoxic medications

Use of dosage forms relating to parenteral products ie intrathecal, epidural injections

Essential skills:

It is critical that the candidate demonstrate the ability to:

Complete and file documentation

Compound raw materials correctly and safely to achieve a quality product

Perform aseptic cleaning and waste management

Perform correct aseptic techniques, including general aseptic techniques and cytotoxic aseptic technique

Perform quality assurance monitoring

Prepare, process and manufacture quality pharmaceutical products for fixed formulae

Produce a product free from microbial or cross contamination

Refer issues identified outside scope of practice to an authorised person

Transport and store product according to NCCTG Guidelines for the Preparation of Pharmaceuticals in Hospitals

Use personal protective equipment appropriately

Work in a safe manner

Work in accordance with relevant organisation policy, legislative requirements, industrial awards and agreements and in-house operating procedures (SOPs)

In addition, the candidate must be able to effectively do the task outlined in elements and performance criteria of this unit, manage the task and manage contingencies in the context of the identified work role

This includes the ability to:

Assemble, maintain, clean and use all equipment used in manufacturing process in a correct and safe manner and ensure a clean work environments

Calculate drug requirements for manufacturing

Perform aseptic techniques and aseptic transfers

Perform cytotoxic aseptic technique

Select and maintain appropriate equipment for manufacturing task

Take into account opportunities to address waste minimisation, environmental responsibility and sustainable practice issues

Use available resources and prioritise workload

Use literacy, numeracy and oral communication skills required to fulfil the position in a safe manner as specified by the health care facility

Use problem solving skills

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.

Personal protective equipment may include:

Gowns

Gloves

Masks

Shoes

Goggles

Environmental conditions may include:

Clean areas

Laminar flow hoods / clean rooms

Cytoguard cabinets / cytotoxic drug safety cabinets isolators / cytotoxic rooms

Materials may include:

Therapeutic agents

Agents considered inactive, that are required for bulking, stabilising, colouring and flavouring the final product

Batch numbers can include:

Batch numbers can consist of any combination of numerals and digits as specified in standard operating procedures that can uniquely identify an individual product or batch for recording and identification purposes.

Materials, manufacturing equipment and packaging devices:

The range of materials, manufacturing equipment and packaging devices to be used is specified by the batch/work sheet

Equipment and machinery used in manufacturing may be disposable r non-disposable and may include:

Balances

Meters

Gauges

Pumps

Spatulas

Ointment slabs

Filters

Syringes

Needles

Compounding may include:

Trituration

Aggregation

Dissolution

Mixing

Dose forms may include:

Parental

Topical

Product may include:

Formulary drugs and non-formulary drugs
eg. clinical trial drugs&special access scheme drugs

Products with the required integrity as well as those whose integrity have been compromised
eg. damaged, contaminated or deteriorated

Routine handling products and products requiring special handling eg. cytotoxics and its spill management, refrigerated and frozen items, light sensitive material and flammables

Product packing may include:

Bulk containers

Client ready units

Containers may include:

Small&large volume infusions bags

Eye droppers

Vials

Syringes

Miscellaneous individual client unit devices

Labels may include:

Typed

Written

Electronically produced

Quarantine period

Quarantine period may be defined as time taken to obtain confirmation of suitability of product/batch for human use.

Storage conditions may include:

Correct temperature

Humidity

Light

Secured

Ventilated

Ambient

Isolated

Correct storage of hazardous substances

Secure and safe storage for controlled drugs

Cleaning methods may include:

Swabbing

Washing

Wiping

Disinfecting

Special storage conditions may include:

Refrigeration

Inflammable store