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Guidelines for competency assessment.

Download Competency Declaration Pro Forma

The CMLS approved competency declaration form which needs to be submitted to your professional body when applying for or renewing your certification is available here.

Documented Process

Competency assessment should be a documented process with training for those undertaking the assessments and some form of review of those assessments. There may need to be an appeal process and a process for what to do with a failure of competence assessment.

The process should be underwritten by the principles of risk management, risk to the individual, risk to other workers, and risk to patients. The purpose of competence assessment is to reduce these risks by identifying gaps in key areas where lack of competence in a particular skill/task may lead to significant risk.


It is recommended that competency is assessed at every two years, at a minimum.

For new employees, especially new graduates, it is recommended that competency be assessed within the first six months of employment.

Who should assess competency:

It is recommended that this be done by the section or department supervisor or delegate. The person assessing the competency of the employee must be impartial, have good knowledge of the role description, the expected tasks and the required outcomes of the person being assessed. This could be performed by the laboratory’s quality officer if they have sufficient knowledge of the laboratory techniques and practices.

What should be assessed:

The level of competency will be determined by the experience and seniority of the employee. The first level or base is what an individual “knows” and is measured by his or her general knowledge. The second level focuses on whether the individual “knows how” to act, as measured by his or her competence. The third level describes whether the individual “shows how” to act, as measured by his or her performance. The apex or fourth level refers to what the individual “does,” as measured by his or her action. Even the newest employee should have their competency assessed for all levels – there will be more emphasis on the higher level the more experience they gain (Howanitz et al 2000).

For simplicity and ease of assessment, Levels 2 and 3 can be combined i.e. assessing whether the individual knows and shows how to act. 

The Competency Based Standards (CBS) were the result of collaboration between AIMS and the other professional bodies and recognise that as the employee gains more experience the tasks become more complex and a higher level of competence is required.

A scientist with two or more years’ experience would be able to use relevant understanding, methods and skills to address complex problems, but a higher level scientist would be able to use relevant understanding, methods and skills to address problematic situations that involve many interacting factors.

Examples from the CBS.

Base grade scientist:

7.2.1 Problems are solved using sound judgement based upon knowledge and practical experience.

7.2.2 Implications associated with various outcomes of decision making are recognised and understood.

Senior scientist:

10.1.1 Initiative in identifying problems and questions which require investigation is demonstrated.

10.3.2 Contributions are made to the interpretation of results and conclusions.

It is therefore recommended that three levels of competency be assessed for all scientists, with more extensive assessment on the second and third level for more experienced and senior staff.


How is competency assessed:

It is recommended that the three levels of competency be assessed using the following techniques.  It can by any combination or all.

Competency can be assessed by (ISO 15189):

a) direct observation of routine work processes and procedures, including all applicable safety


b) direct observation of equipment maintenance and function checks;

c) monitoring the recording and reporting of examination results;

d) review of work records;

e) assessment of problem-solving skills;

f) examination of specially provided samples, such as previously examined samples, inter-laboratory

comparison materials, or split samples.


Level 1 (base level measuring general knowledge)

  • ·       Internal or online quizzes or case studies

  • ·       Review of knowledge pre-analytical variables

  • ·       Internal audits of knowledge of procedures and policies

Level 2 (measuring actual competence and performance i.e. knowing how to act)

  • ·       Observation of practical skills

  • ·       Checking correct use and maintenance of equipment

  • ·       Measuring the outcome of techniques or procedures e.g. accurate dilutions, success of a procedure

  • ·       Internal audits that ensure procedures are followed

  • ·       Review internal and external QC performance

  • ·       Review of output/turnaround times

  • ·       Observation of performing specific techniques or tests

Level 3 (measuring what the individual “does,” as shown by their actions)

  • ·       Review of problem solving or troubleshooting e.g. erroneous results, analyser issues

  • ·       Review of critical result actions

  • ·       Client satisfaction survey

Action required if competency requirements are not met.

Recommended actions for employees that do not meet required competency are:

  • ·       Cease performing the relevant tasks/procedures

  • ·       Retraining by the designated trainer for those tasks/procedures

  • ·       Re-assessment by the designated assessor and preferably another independent assessor


Competency Based Standards  

ISO 15189:

Howanitz PJ, Fine J, Valenstien PN. (2000) Employee competence and performance-based assessment - A College of American Pathologists Q-Probes study of laboratory personnel in 522 institutions. Archives of pathology & laboratory medicine 124(2):195-202

Competency Assessment Checklists

Employers may download the example checklist provided by CMLS. 

Generic Checklist, all staff

Clinical and Medical Scientist Checklist

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