1. OF LABORATORY PERSONNEL
Title: COMPETENCY ASSESSMENT OF
LABORATORY PERSONNEL
(A CASE STUDY OF KEMRI/WALTER REED-CRC LABORATORY KERICHO)
Presenter:
Ochieng Francis Opiyo
QA/QC Coordinator
Organization:
USAMRU-K, KEMRI/Walter Reed Project
Clinical Research Centre Laboratory
Kericho, Kenya

2. Introduction:
The goal of competency assessment is to identify problems with employee performance and to correct these issues before they affect patient care.
Competency assessment is any system for measuring and documenting personnel competency.
Competency is the application of knowledge, skills and behaviours used in performing specific job tasks. 2

3. Objective: Evaluation and Review of WRP
laboratory Competency assessment
in the year 2012 3

4. Materials and Methods:
Study site: KEMRI/Walter Reed Project-clinical research centre Laboratory Kericho
Study design: Retrospective.
Data was reviewed retrospectively from personnel records:
Review of staff competency policy awareness
Review of staff competency records
Review of retraining and/or re-assessment records 4

5. Materials and Methods:
Direct observation:
The employee’s techniques are watched during the examination process, which allows the observer to see if the employee is following the SOP.
The observer uses a custom-designed checklist with specific, observable items, actions or attributes. 5

6. Materials and Methods:…
Monitor records (review worksheets and logs prepared by the employee).
Review and analyze quality control records and results of proficiency tests performed by the employee being evaluated.
Retest or recheck results to compare results among personnel. Discrepancies should be resolved. 6

7. Materials and Methods:…
Assess knowledge or problem solving skills using case studies.
Employees are asked to respond orally or in writing to simulated technical problems.
Policy writing for competency assessment is a critical quality systems issue and is the responsibility of the management. 7

8. Materials and Methods:…
Each policy should be shared with everyone in the laboratory and assessments of all personnel should be documented.
Policy:- “Every employee shall regularly be assessed for competency for the tasks defined in their job description”.
Policies and processes should be reviewed annually or as needed and modified when necessary. 8

9. Materials and Methods:…
Processes describe how the policy will be enacted;
Who will conduct assessments?
What will be assessed?
When will assessments occur? (e.g. annually) 9

10. Materials and Methods:…
The assessor contacts the employee in advance to inform them that the assessment will be done at a pre-arranged time.
The assessment is done while the employee is performing tasks using routine samples.
The assessment is done by a specified method previously described and it is recorded. 10

11. Materials and Methods:…
The results of the assessment are shared with the employee.
A remedial action plan is developed defining required retraining.
The plan should outline specific steps to be taken to resolve or correct the problem with related deadlines.
The employee acknowledges the assessment, related action plan, and reassessment where necessary by signing and dating the records. 11

12. WRP-CRC LAB COMPETENCY CHECKLIST
Date Competency Performed: _____________________________
Employee Name: ______________________________________ Lab Section: ____________________
Test/Procedure: _______________________________________________________________________
Test Kit: __________________________________________________________Version: ________ (WA)
Overall Evaluation: Does not Meet Standard Requires Review Meets Standard
Date of next competency assessment: _________________________________
Employee Comments: ___________________________________________________________________________
Trainer Comments: _____________________________________________________________________________ 12
Lab Director/designee: ____________________ Date __________________
WA-Where Applicable NA-Not Applicable

13. WRP-CRC LAB METHODS OF PERFORMANCE ASSESSMENT
Date Competency Performed: _____________________________
Employee Name: ______________________________________ Lab Section: ____________________
Test/Procedure: _______________________________________________________________________
Test Kit: _____________________________________________________ Version: ____________ (WA)
Method
Trainee
Initials
Trainer
Remarks
Duplicate
Specimen
Unknown (Blind)
Proficiency
Written Test
Case Study
Oral Queries
Other
Lab Director/designee: ____________________ Date __________________
WA-Where Applicable NA-Not Applicable 13

14. WRP-CRC Lab Staff Competency Information
No.
STAFF
ASSAY/ TEST
2011
2012-CURRENT
DUE DATE
Comments 1
AKN
Hematology (CBC/Diff)
August 3, 2012
August 3, 2013
ANNUAL 
Blood parasites identification
14/03/2011
March 7, 2012
May 14, 2013
Coagulation
15/11/2011
November 15, 2012
April 16, 2013
INITIAL  
ESR
N/A
NOT DONE 
Reticulocyte counting
Chemistry
16/11/2011
November 16, 2012
November 16, 2013
 ANNUAL
Dipstick Urinalysis
22/04/2011
Cell Immunophenotyping
30/06/2011 (Retest)
Pregnancy
RPR
MOVED 
Syphilis Confirmatory:Serodia TPPA
DNA PCR
Hepatitis BsAg
rLav
Assay Discontinued 14

15. Calendar of Events for WRP-CRC Lab15

16. WRP-CRC Laboratory Assays
SEROLOGY
CHEMISTRY
HEMATOLOGY
MOLECULAR
MICROBIOLOGY
FLOW CYTOMETRY
PBMC SEPARATION & Cryopreservation 16

17. Results:
The study surveyed a total of 7 sections with 30 personnel who participated in the competency program in the year 2012.
Their results showed that 100% of the sections personnel are aware of the lab’s written competency plan.
Approximately 98% of sections reported reviewing employee competence at least annually or as needed. 17

18. Results:..
Measuring adherence to the laboratory's own competence plan, it was found that the percentage of laboratory employees who complied was 95% overall.
Failure to comply with the laboratory's own competence plan ranged from 2%.
This was due to reagents stock out, equipment breakdown, employee away from work at the time competency was due. 18

19. Results:
Employees who failed competency assessment could not be allowed to continue with their usual work in the sections.
Retraining and/or re-assessment of the failed employee is done
Standard forms were generated in advance and used so that all employees are assessed the same way.
This prevents employees from thinking that the assessments are biased. 19

20. 2012 Competency Assessment Summary

21. Discussion:
Accurate laboratory test results depend on staff being competent in performing a range of procedures that occur throughout the entire examination process
An initial competency assessment may reveal the need for specific training of the employee.
Competency assessments conducted periodically helps to identify or prevent performance problems that may be solved through task-specific training. 21

22. Discussion:
All competency assessments must be recorded, showing date and results, and should be kept in a place where they remain confidential.
These records are part of a laboratory’s quality documents, and should be periodically reviewed and used for continuous improvement.
Defined competency program provides the laboratory with a valuable tool for identifying and correcting issues of employee competency. 22

23. Discussion:…
Competency assessment is an integral part of problem analysis and becomes a key tool in ensuring that errors identified through the quality assurance processes are prevented from recurring.
Competency assessment procedures helps identify problems occurring in the technical aspects of laboratory practice and assess performance deficiencies before they develop into major problems 23

24. Discussion:…
Competency assessment is an opportunity to provide continuing education and performance feedback to employees and to document valuable objective information for performance evaluations
Management of personnel is critical to the success of a quality management program.
Several elements are important in this management process: 24

25. Conclusion:
Job descriptions should reflect all skills needed and accurately describe tasks, roles, and authorities.
The competency of personnel will need to be evaluated at the time of hiring and on a regular/recurring basis.
A very important part of the management process is to seek ways to attract qualified personnel, and to provide motivation and appropriate benefits and working conditions so as to retain adequately trained and competent staff. 25

26. Conclusion:…
Managers must create an environment that will fully support all laboratory personnel in order to maintain a high quality of laboratory performance.
Continuing education is vital to personnel competency, but does not need to be expensive.
New testing methodologies and instruments are constantly introduced to the marketplace, and employees need to update their knowledge and skills. 26

27. Thank you: 27