Standard Operating Procedure- SOP

Name of institution

Competency Assessment ID Code:

Ap 16

Topic & Purpose: Review Period:

This procedure describes the staff’s 1 year
competency assessment

Location: Distribution:

Version number: Annex:

V 1.0 1. Tests and procedures for each
sub-specialty in the laboratory (to
be developed)
2. Competency assessment checklist
3. Competency assessment logbook

Written by:

Name(s), Date(s) and Signature(s) of the Author(s)

Reviewed by:

Name(s), Date(s) and Signature(s)

Authorized by:

Name, Date and Signature

Replaces the version:

Not applicable (1st version)

Changes to the last authorized version:

Institution: Version: 1.0 Date: Number of pages: Name of ID Code: Ap 16
7 procedure:
Competency QM chapter: 9
Assessment
Procedure

Not applicable (1st version)

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Institution: Version: 1.0 Date: Number of pages: Name of ID Code: Ap 16
7 procedure:
Competency QM chapter: 9
Assessment
Procedure

Competency Assessment Procedure

Application.............................................................................................2
Objective................................................................................................2
Definitions..............................................................................................2
References............................................................................................2
Responsibilities......................................................................................2
Operating mode.....................................................................................3
Methodology.......................................................................................3
Competency assessment process.....................................................3
Competency assessment failure........................................................4
Related documents................................................................................5
Annex 1..................................................................................................5
Annex 2..................................................................................................6
Annex 3..................................................................................................7

Application
This procedure ensures staff’s competency in the laboratory.

Objective
This procedure describes how to assess the staff’s competency.

Definitions
To be filled in if necessary

References
To be filled in if necessary

Responsibilities
The Laboratory Director is responsible for:
 ensuring the implementation and supervision of laboratory staff
competency assessments;
 taking any required action as indicated by the assessment
results.

The Quality Manager assigns appropriate staff as Competency

Assessors.

The Competency Assessors are responsible for conducting the

competency assessments and documenting the results.

An observer is advisable if there are sufficient staffs.

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Institution: Version: 1.0 Date: Number of pages: Name of ID Code: Ap 16
7 procedure:
Competency QM chapter: 9
Assessment
Procedure

Operating mode

Methodology
The goal of a competency assessment is to identify potential problems
with employee performance and to address these issues before they
affect patient care. Observations followed by documentation of
remediation are critical components of the competency assessment
process.

Competency assessment process

1. A consistent standard for evaluation of competency should be
applied to all employees.

2. Competency assessment records are retained for the entire time an

individual is employed at the laboratory.

3. The areas requiring competency in the laboratory have been

defined. They are the following:
List here the areas requiring competency in the laboratory XXX

4. A list of all tests and procedures for each sub-specialty in the

laboratory has been made (Annex 1, to be developed).

5. The Competency Assessor, in discussion with the staff member’s

supervisor, will select items from the test list and schedule the
exercise to take place, with an observer if applicable, at a mutually
convenient time.
Competency assessment must be specific for each job description.

6. The assessor will fill in the corresponding checklist (Annex 2) by

directly observing the employee and checking the different records
needed for the assessment. The assessor will be in charge of filling in
the competency assessment logbook (Annex 3).
a) New employee
For a new employee, direct observation is used to assess the
employee's ability to accurately follow the laboratory procedure.
An assessment of competence is done twice in the first year of
employment and annually thereafter.
b) Experienced employee
An evaluation for ongoing competency for an experienced
employee is performed by:
 directly observing performance of routine clinical tests;
 monitoring test result documentation and reporting processes;
 reviewing intermediate test results, QC records, proficiency
testing results, and preventive maintenance records;
 directly observing instrument maintenance performance and
function validation;

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Competency QM chapter: 9
Assessment
Procedure

 assessing test performance by:

o re-testing selected previously analyzed specimens to
validate the reported results;
o reviewing the results of internal blind testing samples or
external proficiency testing samples.
 assessing problem-solving skills.

Competency assessment failure

1. If an employee fails one or more areas of the competency
assessment, the assessor will analyze the problem so that the proper
corrective measures can be identified and implemented.
 Analysis of the problem starts with inspection of the protocols
used for laboratory practice. The protocols should be clear and
concise; if they are inadequate or confusing, this may account
for the employee’s competency failure.
 In proficiency testing, it should be ensured that the proficiency
sample is adequate and that a problem with the sample itself is
not the cause of competency failure.

2. If the protocols are not the cause of the competency failure, the
following questions should be answered:
 Did the employee perform the test incorrectly (i.e., did he/she
not follow the proper test procedure)?
 Did the employee misunderstand the purpose or background of
the performed test (i.e., is he/she unable to solve problems or
adapt the test results to the clinical situation)?
 Did the employee misunderstand the components of the test or
instrument being used?
 Was the employee unable to resolve QC problems?
 Did the employee perform the test accurately but make an error
in the documentation?

3. Discussion of the protocol with the employee that fails competency

is warranted to assess if further action is necessary, based on the
employee's verbal response. This may be sufficient to identify the
reason for competency failure.

4. Actions that can be taken with an employee who fails competency

include:
 having the employee reread the protocol and discuss it with the
supervisor in order to clarify any misinterpretations;
 having the employee produce a flow chart to assist him or her
in properly performing the protocol;
 having the employee observe another trained and competent
employee;

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Procedure

 having the employee practice the failed protocol with known

specimens;
 having the employee correctly retest the specimen originally
tested during the failed competency assessment.

5. Reinstitution of formal training will be necessary if the above

mentioned methods fail to confirm that the employee is competent.

6. Regardless of the selected corrective measures, it is necessary to

repeat the competency assessment once the corrective measures
have been completed. Successful accomplishment of competency for
the employee who has failed the original competency assessment is to
be documented.

7. Discussion of test and QC procedures in a quality assurance-QC

meeting with all employees could help staff to understand how certain
types of errors can be avoided.

8. As a last resort, the employee can be permanently removed from

selected duties and reassigned to another work area.

Related documents
Filled in competency assessment checklist/form will be filed with
records Ref XXX
Competency assessment logbook Ref XXX

Annex 1
Tests and procedures for each sub-specialty in the laboratory
To be developed

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Competency QM chapter: 9
Assessment
Procedure

Annex 2
Competency assessment checklist

Example:

COMPETENCY ASSESSMENT

Date of assessment:

Assessor name:

Observer name (if applicable):

Analyst name: Title:

Evaluation period: To

Method procedure:

Reading of pertinent portions of the SOP

Yes No N/A Comments

Direct observation
Safety policies followed
Preparation of work area
Work area neat and organized
Follows policies, procedures and rules
pertaining to assignment
Preparation/handling of specimen
Preparation/handling of reagents
Preparation/handling of QC
Preparation/handling of equipment and
maintenance activities

Knowledge of criteria for acceptable

specimen
Knowledge of criteria for unacceptable
specimen

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Assessment
Procedure

Annex 3
Competency assessment logbook

Example:

Competency assessment logbook

Name of the laboratory
Employee Date Task Assessor Appraisal Comment
Acceptable
Reassess