Date post: | 15-Dec-2014 |
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Rania Mohamed [email protected]
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