Rania Mohamed El-Sharkawyrania.elsharkawy@alex-mri.edu.eg

Lecturer of clinical chemistry, MRI-Alexandria University ,CPHQ,LSSGBHealth governance –MRI-Alex university unit coordinator

IHI Egypt & NAHQ member

Competency assessment an ISO 15189:2012 accreditation

requirement

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

References : ISO 10015 & ISO 9000

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)

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

Employment training

Professional training

Training

Two types

Employment training is provided for employees who are new to the organization or are new to a differentjob in the organization

Employment

Training

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.

Organization’s quality management system Quality manual Service’s path of workflow Quality control (QC) program Quality assurance program

Components of employment training

Quality

Accident reporting Emergency preparedness Hazardous waste disposal Chemical hygiene program Infection control (universal precautions, bioterrorism, etc.)

Safety

Lab information systemOther computer applications used in the job

Computer

Processes in the path of workflow in which the employee worksProcedures performed

Components of employment training

Job tasks

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

Cognitive: assess knowledge

Psychomotor: assess physical skills

Learning objectives of training could be of three types

Affective: assess actions taken

Moving From Knowledge to Competence

Education knowing exam

Training How it is

doneCompetence assessment

Practice Showing how it is done Performance

Experience Doing it Actions

competenceDoing it

correctly and improving

Written , oral evaluation

Sequence Manifested by

Evaluated by

Components of Competence

Job DescriptionLicense, Certificate

COMPETENCE

Effectiveness assessed through performance improvement activities

Continuing Education & Training

Orientation

Performance Appraisal/Evaluation

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

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

• Competency assessment = snapshot

• Performance appraisal = videotape

WHEN TO do competency assessment ………

• Following initial employment training

• When all staff members are introduced to new or changed work processes or procedures.

Training and Competence Assessment;Approved Guideline—Third Edition

What is the CLSI recommendation ???GP21-A3

Vol. 29 No. 5

• Before working independently, a new employee’s competence is assessedInitial competency

assessment

• The competence of all employees requires at least annual assessment

Ongoing competency assessment

Training and Competence Assessment;Approved Guideline—Third Edition

Cognitive : (assess knowledge)

Initial competency assessment should fulfill ….

• “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

Initial competency assessment should fulfill ….

• psychomotor skills : (assess physical skills)• Fill the curette.

• Fill the sample tray

effective : (assess actions taken)Select the correct course of action when the QC is out of

range.

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

The competence of all employees requires at least annual assessment. The assessments need to includenot only the preanalytical, analytical, and postanalytical activities in the laboratory’s path of work flow, but also aspects of quality managementactivities to which employees are assigned

Ongoing Competence Assessment

Reference :CLSI GP 21-A3

The objective is to determine whether employees are following the documented processes and procedures

Should focus on high-risk steps in laboratoryprocedures.

Direct observation

Methods of ongoing competency assessment tools

Monitoring Results, Reports, and Records

Review of reports and records can reveal mistakes and issues that could be related to lack of competence.

Mistakes and issues should be investigated to determine their causes

Over time,staff members tend to drift away from procedure specifics as they discover shortcuts and workarounds

Why direct observation???

Staff may believe that certain tasks seldom or rarely yield a significant finding and are time consuming

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

Problem-Solving Skills

Methods of ongoing competency assessment tools

Performing a Procedure Using Specially Provided

Materials

Blind samples Previously analyzed samples; known samples

Reliable assessment of routine performance

considered the best and most thorough representation of diagnostic testing

performance

Feasibility ……remains the problem

Benefits of blind samples

Identification of problems within all phases of the path of workflow

Replicate testing of previously analyzed material provides accessible internal comparisons

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

Previously Analyzed Material

Costs can be significantlyreduced

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

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

Be attention …..

Facts

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?

Make sure?

Be attention …..

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

What to do if the competency assessment reveled unacceptable performance ?????

What is unacceptable?

What is the ISO 15189: 2012 requirements for

competency assessment ?

Competency & ISO 15189: 2012

ISO 15189 Medical Laboratories

Particular requirements & competence

35

• 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

Competency & ISO 15189: 2012

15189 and Personnel• 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)

Competency & ISO 15189: 2012

Documentation systems should be selected based on:

• ease of use• efficiency• cost to implement • ability to meet regulatory, accreditation• applicability to the service.

1. Training and competency assessment policy2. Training and development program 3. Training records4. Competency assessment records 5. competency assessment plan

Documents ….. Needed

What is the CAP requirement for

competency assessment ?

CAP Competency Assessment Program and Laboratory Accreditation Program Checklist

Requirement GEN.55500

References: 2013 College of American Pathologists

“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.

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

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.

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

CAP Competency Assessment Program and Laboratory Accreditation Program Checklist

Requirement GEN.55500

Passing score recommended by the CAP:

100%

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

Take home massage

Competency assessment is an accreditation requirement either by the ISO 15189 OR CAP