1. Rania Mohamed El-Sharkawy
rania.elsharkawy@alex-mri.edu.eg
Lecturer of clinical chemistry, MRI-Alexandria University ,CPHQ,LSSGB
Health governance –MRI-Alex university unit coordinator
IHI Egypt & NAHQ member

2. Competency assessment an ISO
15189:2012 accreditation
requirement

3. Lecture objectives ….
•
•
•
•
•
•
•
To identify the difference between competency and training
To define components of competency
To identify the employee training components
To differentiate between performance appraisal and competency
assessment
To describe the ISO 15189:2012 requirements for competency
To describe the CLSI GP21-A3 guidelines for competency
assessment
To overview the CAP requirement for competency assessment

4. ESSENTIAL …
Definitions ………….
competence – application of knowledge, skills, and behaviors in
performance (ISO 10015)
Training – process to provide and develop knowledge, skills, and
behaviors to meet requirements (ISO 10015)
procedure – a specified way to carry out an activity of a process
(ISO 9000)
process – set of interrelated or interacting activities that
transform inputs into outputs (ISO 9000)
References : ISO 10015 & ISO 9000

5. Training , development and competency assessment shall …
 Meet specific quality objectives in support of an
organization’s mission statement.
 Meet standards for job performance and unique to
each organization
 Differs according to the
competitive, economic, regulatory, and service
environment in which the organization operates

6. Training
Two types

Employment training

Professional training

7. Training
Employment
 Employment training is
provided for employees who
are new to the organization or
are new to a different
job in the organization
Professional
Professional training is
training received in the
knowledge and skills of a
particular profession, and is
based on a defined body of
knowledge and skill sets that
prepare the learner for a
future job in that profession.

8. Components of employment training










Organization’s quality management system
Quality manual
Service’s path of workflow
Quality control (QC) program
Quality assurance program
Quality
Accident reporting
Emergency preparedness
Hazardous waste disposal
Chemical hygiene program
Infection control (universal precautions, bioterrorism, etc.)
Lab information system
Other computer applications used in the job
Safety
Computer

9. Components of employment training
Processes in the path of workflow in which the employee
works
Procedures performed
Job tasks

10. WHEN TO train………
•For new employees, to learn their
respective work processes and
procedures
• For all employees, when
organizational or technological
changes affect work processes
•When training needs are identified

11. Learning objectives of training could be of three
types
Cognitive: assess knowledge
Affective: assess actions taken
Psychomotor: assess physical skills

12. Moving From Knowledge to Competence
Sequence
Education
Training
Practice
Experience
competence
Manifested
by
knowing
How it is
done
Showing how it is
done
Doing it
Doing it correctly
and improving
Evaluated
by
exam
Competence
assessment
Performance
Actions
Written , oral evaluation

13. Components of Competence
COMPETENCE
Performance
Appraisal/Evaluation
Continuing
Education & Training
Orientation
Job
Description
License, Certificate
Effectiveness assessed
through performance
improvement activities

14. Competency Assessment
• “Is this staff member able to do his/her
assigned job?”
• Answer: found in comparing employee’s
performance against a set of criteria
• Completed during orientation
• Ongoing to determine if competency
maintained

15. Performance Evaluation
• “Is this staff member doing his/her assigned job?”
• Answer: found in comparing daily performance
against set of expectations
• Compiled and summarized annual basis or as
determined by the organization

16. • Competency assessment =
snapshot
• Performance appraisal =
videotape

17. WHEN TO do competency assessment
………
• Following initial employment
training
• When all staff members are
introduced to new or changed work
processes or procedures.

18. Training and Competence Assessment;
Approved Guideline—Third Edition
What is the CLSI recommendation ???
GP21-A3
Vol. 29 No. 5

19. Training and Competence Assessment;
Approved Guideline—Third Edition
Initial competency
assessment
Ongoing
competency
assessment
• Before working independently, a new
employee’s competence is assessed
• The competence of all employees
requires at least annual assessment

20. Initial competency assessment should fulfill ….
Cognitive : (assess knowledge)
•
“Describe the principle of the test method for blood glucose on
###instrument.”…….tests the theory
•
Explain why you add reagent A before adding reagent B.”……tests
the technique
•The high abnormal control results plotted on a Levey-Jennings chart
show eight data points in a row in an increasing trend from left to
right on the chart. What does this mean and what will you
do?”……test the problem solving capability

21. Initial competency assessment should fulfill ….
effective : (assess actions taken)
Select the correct course of action when the QC is out of
range.
•
psychomotor skills : (assess physical skills)
•Fill the curette.
• Fill the sample tray

22. Validating Initial Competency
• Requirements of position
– Develop skills checklist
– Develop measurable performance criteria
•
Performance standard to compare actual performance against
– Determine method of assessment to be used
– Provide training if required
– Assess

23. Ongoing Competence Assessment
The competence of all employees requires at least
annual assessment. The assessments need to include
not only the preanalytical, analytical, and postanalytical
activities in the laboratory’s path of work flow, but also
aspects of quality management
activities to which employees are assigned
Reference :CLSI GP 21-A3

24. Methods of ongoing competency assessment tools
Direct observation
Monitoring Results,
Reports, and Records

The objective is to determine
whether employees are following
the documented processes and
procedures
 Review of reports and
 Should focus on high-risk
steps in laboratory
procedures.
 Mistakes and issues should
records can reveal mistakes
and issues that could be
related to lack of competence.
be investigated to determine
their causes

25. Why direct observation???
Over time,
staff members tend to drift
away from procedure specifics
as they discover shortcuts
and workarounds
Staff may believe that certain tasks seldom
or rarely yield a significant finding and are
time consuming

26. Methods of ongoing competency assessment tools
Problem-Solving Skills

Problem solving is a very
important competence for
laboratorians and can often save
patient outcomes
Can be taught in case studies
and assessed in simulations
The laboratory’s nonconforming
events are a good source also be
used to determine a person’s
problem-solving capabilities by
reviewing the appropriateness of
the remedial actions and the
follow-up investigations
Performing a Procedure
Using Specially Provided
Materials
 Blind samples
 Previously analyzed samples;
 known samples

27. Benefits of blind samples
Reliable assessment of routine
performance
Identification of problems within all
phases of the path of workflow
considered the best and most thorough
representation of diagnostic testing
performance
Feasibility ……remains the problem

28. Previously Analyzed Material
Replicate testing of previously
analyzed material provides
accessible internal comparisons
Costs can be significantly
reduced
Sample is preserved properly and the
analyte is stable
It is possible to assess cognitive, affective, and psychomotor skills when
assessing competence using previously analyzed samples

29. Validating On-going Competency
• Select competencies (high-risk, low volume, problem prone)
– Develop measurable performance criteria
• Performance checklist
• Performance standard to compare actual performance against
–
–
–
–
Determine method of assessment to be used
Assign appropriate person to perform assessment
Provide training if required
Assess

30. Be attention …..
Facts
literature makes it clear that over
85% of problems are found within
the work processes and procedures
Retraining apparently
“incompetent” employees in
malfunctioning, absent, or highly
variable work processes will not
solve

31. Be attention …..
Make sure?
1-Have all work processes been
clearly documented?
2- Are there documented
procedures for all activities in the
work process?
3- Are the documented procedures
clear and easy to understand?
4- Does the service have a
documented training program for
all work processes and
procedures?

32. What to do if the competency assessment reveled
unacceptable performance ?????
What is
unacceptable?
1-every organization shall establish
its own criteria for unacceptable
performance based on :




Level of performance desired
Job title
Process type
Complexity and risky operations
2- Every organization shall
determine the criteria for
retraining when competency
assessment is not acceptable

33. What is the ISO 15189: 2012
requirements for
competency assessment ?

34. Competency & ISO 15189: 2012
ISO 15189 Medical Laboratories
Particular requirements &
competence

35. Competency & ISO 15189: 2012
• The laboratory shall be directed by a person or persons having executive
responsibility and the competence to assume responsibility for the
services provided.(clause 5.1.3)
• (note: competence is the product of basic, academic, postgraduate, continuing
education, and training and experience of several years in a medical laboratory
35

36. 15189 and Personnel
Competency & ISO 15189: 2012
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Laboratory management shall have an organization plan, personnel policies
and job descriptions that define qualifications and duties for all personnel.
The laboratory management shall maintain records of the relevant education
and professional qualifications , training and experience and competence of
all personnel (clause 5.1.2)
Laboratory management shall authorize personnel to perform particular tasks.
Personnel shall have training specific to quality assurance and quality
management for services offered.
There shall be a continuing education program available to staff at all levels.
Employees shall be trained to prevent or contain the effects of adverse
incidents.
The competency of each person to perform assigned tasks shall be assessed
following training and periodically thereafter. Retraining and reassessment
shall occur when necessary. (clause 5.1.11)

37. Documents ….. Needed
1.
2.
3.
4.
5.
Training and competency assessment policy
Training and development program
Training records
Competency assessment records
competency assessment plan
Documentation systems should be selected based on:
•
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ease of use
efficiency
cost to implement
ability to meet regulatory, accreditation
applicability to the service.

38. What is the CAP
requirement for
competency
assessment ?

39. CAP Competency Assessment Program and
Laboratory Accreditation Program Checklist
Requirement GEN.55500
“The competency of each person to
perform his/her assigned duties is
assessed”
“Evidence of Compliance:
Records of competency assessment for new and
existing employees reflecting the specific skills
assessed, the method of evaluation.
References: 2013 College of American Pathologists

40. CAP Competency Assessment Program and
Laboratory Accreditation Program Checklist
Requirement GEN.55500
Direct observations of routine patient test performance, including
patient preparation, if applicable, specimen
handling, processing, and testing
Monitoring the recording and reporting of test results
Review of intermediate test results or worksheets, quality control
records, proficiency testing results and preventive maintenance
records
Direct observation of performance of instrument maintenance and
function checks
Assessment of test performance through testing previously
analyzed specimens, internal blind testing samples or external
proficiency testing sample
Evaluation of problem-solving skills

41. CAP Competency Assessment Program and
Laboratory Accreditation Program Checklist
Requirement GEN.55500
Does the evaluation involve EVERY employee?
If they are performing NON-WAIVED testing:
Yes.
If they are performing Waived, then :
you can CHOOSE to or NOT.

42. CAP Competency Assessment Program and
Laboratory Accreditation Program Checklist
Requirement GEN.55500
What is the frequency recommended by the CAP:
During the first year of an individual's
duties, competency must be assessed at least
semiannually

43. CAP Competency Assessment Program and
Laboratory Accreditation Program Checklist
Requirement GEN.55500
Passing score recommended by the CAP:
100%

44. Take home massage
Competency assessment is an accreditation requirement either by
the ISO 15189 OR CAP
Each organization shall develop its competency
assessment program for each job title including:
 initial as well as ongoing phases
Methodology
 With predetermined acceptable performance criteria
The competency assessment program shall follow guidelines to make the maximum
organizational benefits