Unit of Competency Mapping – Information for Teachers/Assessors – Information for Learners

HLTPH410C Mapping and Delivery Guide
Prepare batch and work sheets and labels for compounding

Version 1.0
Issue Date: April 2024


Qualification -
Unit of Competency HLTPH410C - Prepare batch and work sheets and labels for compounding
Description This unit of competency describes the skills and knowledge required to prepare master work sheets for use in batch or extemporaneous product manufacture
Employability Skills This unit contains Employability Skills
Learning Outcomes and Application All tasks are conducted according to NCCTG Guidelines for the Preparation of Pharmaceuticals in Hospitals and standard operating procedures (SOPs) and the Australian Pharmaceutical Formulary and HandbookWork performed requires a range of well developed skills where discretion and judgement is requiredIndividuals will take responsibility for their own outputs and limited responsibility for the outputs of others
Duration and Setting X weeks, nominally xx hours, delivered in a classroom/online/blended learning setting.
Prerequisites/co-requisites Not Applicable
Competency Field
Development and validation strategy and guide for assessors and learners Student Learning Resources Handouts
Activities
Slides
PPT
Assessment 1 Assessment 2 Assessment 3 Assessment 4
Elements of Competency Performance Criteria              
Element: Source information on formula
  • Select appropriate dosage form for product, based on client need and/or against application of drug
  • Use validated resources to source available formulae for required product
  • Consolidate and make relevant information available
  • Confirm suitability of chosen formula and availability of resources
  • Obtain authority of pharmacist to proceed
       
Element: Design master batch/work sheet and labels
  • Use template to create a master batch/work sheet, if available
  • Create a master batch/work sheet based on existing institutional format if a template is not available
  • Verify that master batch/work sheets are clearly written in logical order with no ambiguous directions
  • Verify that master batch/work sheets contain all the required information
  • Create a master label that is within legislative requirements; contains name, form and strength of product; provides spacing for entry of batch numbers and expiry date and includes hazard warnings
  • Include ancillary labels as part of label details, according to organisation policy
  • Where specified, create batch record sheet for recording details of dates and quantities of products to be made and released for use
       
Element: Seek approval and release of batch/work sheets for use
  • Submit master batch/work sheet and labels to pharmacist for approval
  • Once released by pharmacist, make copies of master batch/work sheet and store in designated work sheet storage file
  • File master batch/work sheet
       


Evidence Required

List the assessment methods to be used and the context and resources required for assessment. Copy and paste the relevant sections from the evidence guide below and then re-write these in plain English.

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

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

Documents/references on pharmaceutical formulations

Instructions on the use of equipment

Method of assessment may include:

Observation in the work place (if possible)

Written assignments/projects

Interviewing and questioning

Formal appraisal systems

Supporting statement of supervisor(s)

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


Submission Requirements

List each assessment task's title, type (eg project, observation/demonstration, essay, assignment, checklist) and due date here

Assessment task 1: [title]      Due date:

(add new lines for each of the assessment tasks)


Assessment Tasks

Copy and paste from the following data to produce each assessment task. Write these in plain English and spell out how, when and where the task is to be carried out, under what conditions, and what resources are needed. Include guidelines about how well the candidate has to perform a task for it to be judged satisfactory.

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

Essential knowledge:

The candidate must be able to demonstrate essential knowledge required 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 knowledge of:

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

Formulation resources

Hospital or health facility in-house computer system

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

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

Issues of pharmaceutical procedures, relevant to formulation and calculation

Knowledge of and the rationale for applicable legislation, organisation policy and
in-house standard operating procedures (SOPs), relating to preparing batch and extemporaneous master work sheets and labels

Nature and usage of different drug dosage forms

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

Principles and procedures of maintaining security of pharmaceutical products

Principles and procedures of stock control and maintenance

Principles of good manufacturing practice as per NCCTG Guidelines for the Preparation of Pharmaceuticals in Hospitals

Principles of mathematics in relation to formulation calculations

Purpose of batch numbering and expiry date on medicines

Storage requirements and rationale for different types of product

Essential skills:

It is critical that the candidate demonstrate the ability to:

Design master batch/work sheet and labels to meet organisation and legislative requirements

File master and copied documents according to organisation requirements

Refer issues identified outside scope of practice to an authorised person

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:

Enter and access data on pharmacy computer system

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

Use available resources and prioritise workload

Use formulation resources to prepare a master batch sheet

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

Use validated formulation resources to formulate a stable, pharmaceutically correct, quality product

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:

Raw drug materials list

Equipment required

Preparation instructions

Storage and stability data

Packaging and label requirements

Master batch/work sheets must:

Be clearly written

Be in logical order

Contain all required information

Contain no ambiguous directions

Master label must:

Be within legislative requirements

Contain name, form and strength of product

Provide spacing for entry of batch numbers and expiry dates

Include hazard warnings

Include ancillary labels as part of label details

Copy and paste from the following performance criteria to create an observation checklist for each task. When you have finished writing your assessment tool every one of these must have been addressed, preferably several times in a variety of contexts. To ensure this occurs download the assessment matrix for the unit; enter each assessment task as a column header and place check marks against each performance criteria that task addresses.

Observation Checklist

Tasks to be observed according to workplace/college/TAFE policy and procedures, relevant legislation and Codes of Practice Yes No Comments/feedback
Select appropriate dosage form for product, based on client need and/or against application of drug 
Use validated resources to source available formulae for required product 
Consolidate and make relevant information available 
Confirm suitability of chosen formula and availability of resources 
Obtain authority of pharmacist to proceed 
Use template to create a master batch/work sheet, if available 
Create a master batch/work sheet based on existing institutional format if a template is not available 
Verify that master batch/work sheets are clearly written in logical order with no ambiguous directions 
Verify that master batch/work sheets contain all the required information 
Create a master label that is within legislative requirements; contains name, form and strength of product; provides spacing for entry of batch numbers and expiry date and includes hazard warnings 
Include ancillary labels as part of label details, according to organisation policy 
Where specified, create batch record sheet for recording details of dates and quantities of products to be made and released for use 
Submit master batch/work sheet and labels to pharmacist for approval 
Once released by pharmacist, make copies of master batch/work sheet and store in designated work sheet storage file 
File master batch/work sheet 

Forms

Assessment Cover Sheet

HLTPH410C - Prepare batch and work sheets and labels for compounding
Assessment task 1: [title]

Student name:

Student ID:

I declare that the assessment tasks submitted for this unit are my own work.

Student signature:

Result: Competent Not yet competent

Feedback to student

 

 

 

 

 

 

 

 

Assessor name:

Signature:

Date:


Assessment Record Sheet

HLTPH410C - Prepare batch and work sheets and labels for compounding

Student name:

Student ID:

Assessment task 1: [title] Result: Competent Not yet competent

(add lines for each task)

Feedback to student:

 

 

 

 

 

 

 

 

Overall assessment result: Competent Not yet competent

Assessor name:

Signature:

Date:

Student signature:

Date: