1. This teaching material has been made freely available by the KEMRI-Wellcome Trust (Kilifi, Kenya). You can freely download, adapt, and distribute this presentation under the conditions that: the Global Health Laboratories and The Global Health Network are referenced; the work is not used for commercial purposes, and any altered forms of this document are distributed freely under the same conditions. www.GlobalHealthLaboratories.org

2. Laboratory Organization & Personnel 2 KEMRI-Wellcome Trust Research Programme

3. 3 Learning Objectives At the end of this session, you will be able to Describe organizational elements needed for a GCLP Laboratory. Discuss management roles and responsibilities in organization. Describe the role of personnel in the organization. Develop a plan to train and verify employee competency.

4. Learning Objectives Describe the steps involved in assessing and maintaining employee competency. Identify potential sources of employee performance problems. Able to explain a process to maintain personnel records. 4

5. What is Organization? Social unit of people, systematically arranged and managed to meet a need or to pursue collective goals on a continuing basis.need goalscontinuing All organizations have a management structure that determines relationships between functions and positions, and subdivides and delegates roles, responsibilities, and authority to carry out defined tasks.managementstructurerelationshipsfunctionspositionsroles responsibilitiesauthority tasks http://www.businessdictionary.com/definition/organization.html#ixzz17Ugx7ooN 5

6. 6 Management Roles & Responsibilities  Organizational Structure  establish a working structure that ensures sufficiency at all parts in the laboratory work flow.  develop an organization chart, designate responsibilities and roles.

7. 7 Management Responsibilities  Develop Policies & Quality Systems (Improve) Implement and continuously improve the quality system. Document and communicate to all personnel.

8. 8 Management Roles & Responsibilities  Provide Leadership Exercising responsible authority, while providing motivation and vision. Build the team that is cohesive. Influencing and encouraging staff to good performance.

9. 9 Management Roles & Responsibilities  Provide Resources Financial requirements/budget Review Personnel needs: – additional staff – skills, training needed Facilities, equipment, supplies, computers

10. Laboratory Staff Responsibilities  Laboratory Staff Laboratory’s greatest asset: – critical to quality – partners in public health – qualified professionals 10

11. 11 Laboratory Staff Responsibilities  request training that may be needed as job responsibilities increase ;  maintain records of personal professional development

12. LABORATORY PERSONNEL PART 2 12

13. LAB STAFF TRAINING Why Train staff: To ensure that the staff is fit for purpose. To provide needed skills that meet service requirements applicable to your organization’s needs. To create awareness aimed at educating the staff on relevance and importance of their activities. To enable staff understand how they contribute to achievement of quality objectives. 13

14. STAFF TRAINING  Types of Training: Induction & Orientation – Process by which a new staff is integrated into organization's system. – All new staff should undergo comprehensive induction program. Occupational Health & Safety – H & S enables staff to safely undertake a task/role to comply with Lab Bio-safety guidelines and your organization’s safety policies. – H&S Training should be mandatory for both new & existing staff Job Training – New staff is assigned to a Lab section specific to the task. – Staff on job training should rotate through all areas of the Lab. 14

15. 15 Orientation Training

16. 16 Orientation Competency Assessment Task-specific Training Competency Recognition Job Description Qualified New Employee Retraining

17. Methods of Training Coaching – More intensive training. – Involves a close working relationship between an experienced employee and the trainee. – Involves showing trainee how to do the job by demonstration & providing instructions. – Hands-on-the job 17

18. Methods of Training Workshops / tutorials – Interactive learning in which learner & facilitator share the learning activities. – May involve online tutorials – Certificate of attendance is issued after successful completion of competency testing. Seminar / Conferences – Training involves listening & questioning. – Training is documented on attendance record. 18

19. When to perform staff Training! When staff is newly hired. When job responsibilities or duties change. When recommended as part of a corrective action investigation. When new procedures are introduced. As part of annual training e.g fire drill After an unsuccessful competency assessment. 19

20. COMPETENCY TESTING What is competency testing? – A Systematic process that allows for a measurable assessment of the staff’s ability to perform required activities. Purpose of competency testing – will assess the knowledge, skills and attitude necessary to perform the job effectively. 20

21. When to initiate Competency Testing. After the initial On-Job training. Annually review that the staff maintains the competence. When the roles and responsibility of the staff changes. 21

22. Methods of Competency Testing Direct observation – of routine assay or procedure performance. – involve the observation of performance of instrument maintenance and function checks. Blinded testing – Assessments of test performance of previously analyzed, well-characterized specimens. – Previous EQA materials 22

23. Methods of Competency Testing vendors or suppliers competency – Staff being trained by the manufacturer or vendor – involves the issuing of statement of competency Statement of Competency – Based on long term experience known to Lab management. 23

24. 24 Competency Assessment Methods Direct Observation  checklists Indirect Observations – monitoring records – re-testing – case studies Technologist NameTechnologist Title Procedure for Evaluation Evaluation DateEvaluator Procedure itemAcceptPartialNoComment Read procedure manual Equipment set up appropriately Work area neat Reagent preparation Perform task accurately Perform task timely Other: Specify

25. 25 Competency assessment documentation use standard forms date and keep confidential

26. Competency Testing Ratings  Assessment Ratings should be defined  3= competent to train and assess others.  2= competent to perform the task independently  1= needs more training  Unsuccessful Competency Testing – Corrective actions – Sack/Fire? 26

27. DOCUMENTATION OF STAFF TRAINING Each trainee need Training Record Form (TRF) in which every training will be documented. – The record will show the training activity, – date of training initiation and completion – and the name/initials of the trainer Training records filed in Personal Training folder. – Reviewed – Audited 27

28. DOCUMENTATION OF STAFF TRAINING What is a Personnel Training File (PTF) ? – Does any participant have the PTF? Provide evidence that an individual is fit to perform the assigned tasks – correct manner – Possess appropriate education – Are qualified – Suitably trained – Are experienced 28

29. Content of PTF Formal qualification Curriculum vitae Job Description Induction and Orientation Training Record of Training Received- In house Courses attended-Safety, QAQC, GCLP Conferences & meetings attended Record of Review 29

30. 30 Job Descriptions “Laboratory Management shall have job descriptions that define qualifications and duties for all personnel.” ISO 15189:2007

31. 31 Competency Assessment Job Description Task-specific Training Competency Recognition Retraining

32. Job Description Describe the nature & level of work performed. Define the purpose, responsibilities, accountabilities and authorities of a job. Clear definitions of the line of authority Define knowledge, skills and abilities required for the task 32

33. Job Description Each individual should have their own job description. Signed and dated by individual staff and their line manager. The current JD and the previous JD should be retained in the individual’s training file. 33

34. CURRICULUM VITAE What is a Curriculum Vitae? – Written summary of personal, educational records and work history. – Every staff member should maintain an updated CV Purpose of CV – CV speaks on behalf of an individual 34

35. Content of CV Full name Academic qualifications Professional experience Current & previous position held. Achievements of relevance Membership of relevant professional groups Papers published 35

36. 36 Personnel Records Performance Appraisal Competency Assessmen CONFIDENTIAL Kawuondo Training Records Competency Assessment

37. 37 Performance Appraisal professional behavior punctuality customer service communication observation to safety adherence to policy competencies

38. 38 Performance Appraisal Meetings  formal  regular  constructive  objective  complete  fair  documented

39. 39 Staff Equals Workload Job Qualifications Performance Appraisal Continuing Education Competency Assessment Training Orientation Job Descriptions Personnel Management

40. THANK YOU COMMENTS !! SUGGESTIONS !! QUESTIONS ?? 40