Staff Competency Assessment in Labs: Methods and Records

Staff competency assessment is the documented process of checking that each person can perform a specific laboratory task correctly and consistently, using objective evidence such as direct observation, blind samples and proficiency testing results. Training gives people the knowledge; competency assessment proves they can apply it, and authorisation formally allows them to do the work.

Both ISO 15189:2022 and ISO/IEC 17025:2017 require laboratories to define competence requirements, assess staff against them, authorise people for specific activities and monitor competence over time. Weak competency records are one of the most common personnel findings at assessment, usually because the lab has training certificates but no evidence of assessed performance.

What the standards require

Both standards cover personnel in clause 6.2. ISO/IEC 17025:2017 requires documented competence requirements for each function, and procedures for selection, training, supervision, authorisation and monitoring of competence. It lists activities that need specific authorisation, including method development, verification and validation, analysis of results and statements of conformity, and the review, reporting and authorisation of results.

ISO 15189:2022 has similar requirements and adds medical laboratory specifics. Personnel must be authorised for activities such as method selection, verification and validation, review, release and reporting of results, and use of the laboratory information system, including entering or changing patient results. Competence must be reassessed periodically and retraining provided where needed.

Neither standard fixes a frequency or a list of methods. Your accreditation body, such as NABL in India or EIAC in the UAE, may publish further guidance. In the US, the CLIA regulations specify six assessment elements for certain test categories, and many labs elsewhere use them as a practical model.

Training vs competence vs authorisation

These three words are often used interchangeably. They should not be:

• Training is the process of giving someone knowledge and skills, such as reading the SOP, watching a demonstration and practising under supervision.
• Competence is the demonstrated ability to apply that knowledge and skill to produce correct results.
• Authorisation is the formal, recorded decision by a responsible person that someone may now perform a task independently.

A signed training record shows attendance, not that someone can read a Gram stain correctly. Assessors look for evidence of performance.

Competency assessment methods

Use more than one method per task, because each proves something different.

Blind samples are especially useful in microbiology, where interpretation matters as much as technique. Use retained samples or leftover EQA material, and set acceptance criteria before the assessment.

How often to assess competence

Use four triggers:

1. Initial assessment before a person is authorised to work independently on a task.
2. Periodic reassessment at a defined interval, commonly annually, set by your procedure and any accreditation body or regulatory requirement.
3. After a change, such as a new method, instrument, software version or major SOP revision.
4. After a concern, such as a failed PT result, repeated errors, a complaint or a long absence from the task.

Under CLIA in the US, for example, competency is assessed twice in the first year and annually after that for relevant testing. Where no rule applies, base the frequency on risk: high-risk, high-judgement tasks such as blood culture work-up or antimicrobial susceptibility testing justify closer monitoring than routine media preparation.

The authorisation matrix

An authorisation matrix (or skills matrix) shows, for each person and each task, whether they are in training, competent and authorised, or due for reassessment. It is usually a spreadsheet or a module in the LIMS or quality software, with rows for people and columns for tasks.

Keep it current and controlled, with the date of the last assessment, who authorised the person and a link to the evidence. Supervisors use it to plan rotas, so a technologist is never put alone on a task they are not authorised for. Assessors often pick a reported result and ask to see that the person who released it was authorised on that date.

When competence is not demonstrated

A failed assessment is not a disciplinary event. It is information. Record what was not met, withdraw or restrict authorisation for that task, retrain with a clear plan and reassess using the same criteria. If results were released by that person, assess whether any reported results could be affected and handle this through your nonconformity and CAPA process.

Worked example: onboarding a technologist in a Kochi microbiology lab

A hospital microbiology laboratory in Kochi accredited to ISO 15189 hires a technologist with three years of experience elsewhere. Experience is useful, but authorisation does not transfer; the lab must assess her against its own methods.

The quality manager and section head set out a six-week plan. In week one she completes induction, biosafety training and SOP reading for specimen processing, Gram staining and plate reading. Signed SOPs count as training, not competence.

In weeks two to four she works under supervision. The section head observes her processing 20 urine and wound samples using a checklist that covers labelling, biosafety cabinet use and plate selection. She stains and reads 15 retained slides with known results, blind to the expected answers, with a pre-set criterion of full agreement on Gram reaction and morphology. She misreads two slides with Gram-variable organisms, so the section head reviews them with her, assigns ten more practice slides and reassesses. She then meets the criterion.

In week five she completes a quiz on culture media QC and a problem-solving case on a failed QC organism, then reads plates from a recent EQA sample alongside a senior colleague. The section head signs her authorisation for specimen processing, Gram staining and routine culture reading, and the matrix is updated. Antimicrobial susceptibility testing is assessed separately next quarter, so she cannot yet release those results.

Common mistakes

• Treating a signed SOP read-and-understood form as proof of competence
• Assuming experience in another lab equals authorisation in yours
• Using one method only, usually direct observation
• Setting pass criteria after seeing the results
• Letting the matrix fall out of date, so rotas do not match authorisations
• Forgetting reassessment after a new instrument or method
• Assessing technical tasks but not LIS result entry and release

Key takeaway: Training is what you give people, competence is what they show you, and authorisation is what you record. Use several assessment methods with pre-set criteria, reassess on a defined schedule and after change, and keep an authorisation matrix that links every task to evidence.

Frequently Asked Questions

What is the difference between training and competency assessment?

Training is the process of giving someone the knowledge and skills for a task, such as SOP reading, demonstration and supervised practice. Competency assessment is the separate step of checking, with objective evidence, that the person can actually perform the task correctly. A person can complete training and still not be competent, which is why both are recorded.

How often should laboratory staff competency be assessed?

ISO 15189:2022 and ISO/IEC 17025:2017 require periodic monitoring but do not fix an interval. Many laboratories reassess annually, plus after any change in method, equipment or software and after performance concerns. Some regulations, such as CLIA in the US, set specific frequencies. Check your accreditation body's guidance and base the interval on task risk.

Can a blind sample be used for competency assessment?

Yes. Blind or previously tested samples are one of the strongest methods because the person does not know the expected result. Use retained patient samples, leftover EQA material or prepared samples with known values. Define acceptance criteria before the assessment and record expected and obtained results, along with any action taken when results disagree.

What should a competency record include?

A competency record should identify the person, the task and the method version, the assessment methods used, the acceptance criteria, the results obtained, the assessor's name and date, and the outcome. It should also show the authorisation decision, who made it and when reassessment is due. Link it to the supporting evidence so an assessor can trace it.

Next steps

To build competence systems that stand up at assessment, explore our ISO/IEC 17025 Advanced: Laboratory Competence & Accreditation or ISO 15189 Advanced: Medical Laboratory Quality & Competence course. You can also speak to a counsellor about which suits your role.

For related reading, see ISO 17025 vs ISO 15189: which standard, EQA vs proficiency testing and Gram staining procedure and interpretation.