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.
While statutory or legal compliance is the responsibility of all personnel, supervisors have an important leadership role in promoting and monitoring workplace practices which enhance compliance.

Statutory and legal requirements could include
general duty of care
privacy legislation
ethics committee requirements
maintenance and confidentiality of records
maintenance of records of breaches
maintenance of certified reference materials and regulation 80 certificates
provision of information and training
regulations and Codes of Practice relating to hazards present in the work area
representative work groups/committees
dispute resolution.

Statutory or legal compliance may include but is not limited to
OHS and environmental legislation
NATA accreditation
Australian standards, such as-
AS ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories
AS 2243 Laboratory safety
AS 2500 Storage of goods
AS 1514 Measurement terminology
AS 2415 and AS 2000 Calibration systems requirements
Therapeutic Goods Administration, Code of GMP
trade practices, weights and measures
Environmental Protection Agency
workers' compensation, WorkCover, industrial relations
National Measurement Act.

Ethical considerations may include but are not limited to
identification and impartial resolution of ethical issues, such as conflict of interest
ethical decision making
provision of products and services which match the operational and financial needs of stakeholders, including realistic quotes for work
accurate representation of skills, services, knowledge and qualifications of individuals and the organisation
acknowledgment of services and products developed by others, intellectual property, copyright
provision of unbiased, accurate and appropriately qualified information results.

Communication could involve
managers and supervisors
laboratory and production staff
regulating authorities
explanation of legislation, codes, standards and work practices, such as-
handling and use of animals (Animal Welfare Code 64)
OGTR guidelines for working with genetically altered organisms
obtaining permits as required for collection of botanical and animal specimens
minimising potential infection and contamination hazards and disposal of biological materials (for example, blood, urine, body tissues) which may be infected with hepatitis B and C, HIV/AIDS
Food Standards Code, export regulations governing enterprise products
ethics committee requirements
freedom of information
equal opportunity and anti-discrimination
privacy act
intellectual property and copy right
natural justice.

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. Candidates must be able to supervise laboratory operations to ensure that the work or functional area complies with legislation and laboratory licensing, registration, or accreditation requirements (for example, NATA) and the enterprise's policies and procedures.

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

ensures work practices are conducted in and ethical and professional manner
monitors and analyses work practices to ensure compliance and takes appropriate actions to rectify potential problems or instances of non-conformance
provides information and training on roles and responsibilities and enterprise procedures dealing with legal/statutory requirements
communicates appropriately with all customers (internal and external) and is aware of cultural and social contexts
negotiates changes to work processes and procedures to meet statutory or legal requirements
develops and introduces practices to improve the work environment
provides coaching and mentoring support to personnel to change work practices
keeps required records complete, current and secure.

Underpinning knowledge

Competency includes the ability to apply and explain:

enterprise procedures governing document control, record management, communication and reporting, internal and external audits
scientific technical terminology used to describe legislative, licensing, or registration requirements (for example, traceability)
legal, ethical and welfare issues associated with laboratory and technical work
role, structure and responsibilities of ethics committees
statutory or legal compliance requirements, such as-
legislation governing laboratory operations
National Measurement Act
NATA accreditation
relevant health, safety and environment requirements.

Assessment context and methods
This unit of competency should be assessed in a laboratory environment that either meets Australian Standards for working laboratories or is accredited by NATA or the Royal College of Pathology, as appropriate.

The following assessment methods are suggested:

observation of the candidate's interactions with personnel
review of verified records and reports generated by the candidate
feedback from managers regarding the candidate's ability to implement relevant enterprise procedures
review of information developed by the candidate and provided to the workgroup.
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:

PMLCOM500B Provide information to customers
BSZ404A Train small groups
PMORG600B Supervise laboratory operations in work/functional area
PMLCOM601B Develop and maintain laboratory documentation.

Resource implications

Resources may include:

laboratory equipped with appropriate equipment, instruments, services and consumables
relevant enterprise policies, procedures, operational reports, financial reports and stock records
technical manuals, SOPs, quality manuals and quality system documentation.

This competency in practice
A pathology laboratory is preparing for NATA assessment. The role of one laboratory supervisor is to organise information sessions to inform personnel about the standards and codes to be followed for accreditation. These cover issues, such as working with biological, chemical and radiation hazards; the use of safety equipment; the disposal of waste; ethics committee requirements and patient confidentiality. Training is provided to ensure all personnel are equipped with sufficient knowledge and skills to fulfil their responsibilities in line with the relevant codes and standards. The thorough preparation of the laboratory personnel by the laboratory supervisor assists the laboratory to gain NATA accreditation.
A laboratory supervisor is asked to do an internal audit of a work area as part of an analytical laboratory's preparation for a NATA assessment. The supervisor checks items, such as the currency of the quality manual and laboratory documentation, the storage of reference standards and compares the documentation of test results with NATA requirements. As a result of this internal audit, the supervisor is confident that the forthcoming NATA assessment will show that the work area complies with all requirements.
A team of technical assistants performs a common set of food analyses that are essential to the operations of a food processing company. After a period of rapid staff turnover, their supervisor noticed that the degree of variance in the analytical results has increased. An internal proficiency study confirmed that this rise was not due to compositional differences between samples. The supervisor sought to overcome this problem by first discussing it with the team. The supervisor realised that some of the recently employed technical assistants did not fully understand some analytical procedures. Furthermore, each member of the team, for various reasons, has a distinct preference for performing some procedures over others and this appeared to influence their competency to conduct all other analyses.
In consultation with the team, the supervisor made several changes to the way they work. A more structured induction of new staff was introduced and where possible each technician was allocated the analyses that they preferred and were most competent to perform. The supervisor also instigated a review of the analytical methods involved and identified the critical steps in each assay as defined by the laboratory's accreditation authority. Particular attention was paid to steps regularly misunderstood by one or more technicians in the past and a series of 'critical operating procedures' were developed. These procedures, together with the standard operating procedures, were clearly displayed in the area where the relevant assay was conducted. Overall, these actions by the laboratory supervisor improved the work performance and satisfaction of the staff, maintained the laboratory's standards of compliance and enhanced the level of communication and cooperation with the team.

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
(3)

Collecting analysing and organising information
(3)

Planning and organising activities
(3)

Working with others and in teams
(3)

Using mathematical ideas and techniques
(2)

Solving problems
(3)

Using technology
(2)