Organization and Personnel

1. Organization and Personnel Version 5.0, August 2012

2. Objectives • Define the elements of a quality organization. • Describe the requirements for maintenance of organizational, personnel and training records. • List the requirements for effective employee training programs.

3. Objectives (cont’d) • Define the difference between training and competency. • Describe the different methods to use in evaluating competency. • Define the essential elements of an effective competency development program.

4. Which of the following is the most important asset to an organization? Well defined policies and standards State of the art laboratory equipment Adequately trained staff None of the above Pre-Assessment Question #1 4

5. Curriculum vitae (CVs) should document evidence of: Theoretical knowledge Training received Practical experience Minimum educational qualifications required for the current job A, B, and C A and C only Pre-Assessment Question #2 5

6. Pre-Assessment Question #3 • Training that maintains, enhances, or increases the proficiency of employees is considered: • Initial Training • Continuing Training • Retraining 6

7. Competence compares an employee’s performance against: The Training Plan Standards Policies/procedures B and C Pre-Assessment Question #4 7

8. Pre-Assessment Question #5 • Which of the following methods can be used for competency evaluation? • Blinded testing • External Quality Assurance (EQA) • Quality Control (QC) testing • Direct observation • Review of temperature monitoring records • All of the above 8

9. Which of the following is an element of an effective competency development program? Methods for performing competency evaluation Documentation of competency assessment A Standard Operating Procedure (SOP) for competency evaluation All of the above Pre-Assessment Question #6 9

10. Organizations and Personnel Concepts: • A laboratory is defined by the people who work in it. • A laboratory’s success depends on the management and staff who maintain continuity and ensure that all procedures are conducted adequately. • Personnel and organizational policies must be documented. Quality People Quality Service Quality Organization = =

11. Organization Laboratory Scope Job Profiles Organizational Structure Assignment of Responsibilities

12. Organizational Charts Should list all positions and how they relate to each other Effective way to communicate organizational, employee, and enterprise information Allows for organizing the laboratory team with clear responsibilities, titles, and lines of authority 12

13. Haematologist Consultant Haematology Laboratory Laboratory Supervisor Flow Cytometry Laboratory Supervisor PCR Laboratory Supervisor (Safety Officer) Techs (2) Techs (2) Assistants (2) Techs (3) Assistant (1) Organizational Charts (cont’d) Functional Specialist positions and other areas Line Supervisor - Incumbent Lateral Departmental relationship Staff Advisory role. No authority Laboratory Director Laboratory Manager QA Manager 13

14. Laboratory Scope All testing activities should be listed. 14

15. Assignment of Responsibilities • Job profiles • List of Job specifications, such as: • Qualifications • Experience • Licensing • Other desirable qualities needed • Should be available for all positions(including Laboratory Director) • Could be incorporated in the job description

16. Assignment of Responsibilities (cont’d) Lists of the general tasks or functions and responsibilities of a position Also includes to whom the position reports Job Descriptions Holds personnel accountable for performing assigned activities Should be signed/dated by job-holder and supervisor 16

17. Personnel The laboratory is required to demonstrate that its personnel is adequately… Trained Qualified Competent Educated …to perform their assigned activities. 17

18. Personnel Records Maintain records of Education Qualifications Skills Training Competency Applicable licenses Professional registrations

19. As well as…. Curricula Vitae Education and Qualifications Maintenance of Valid professional licenses or registrations, where applicable Transcripts Copies of Certificates and Diplomas

20. The sponsor has requested to review personnel records in order to verify that the laboratory employees are adequately qualified, trained, and proficient in performing their assigned duties. What records should the Laboratory Manager provide? Job descriptions Salary packages CVs Training and competency records Written warnings A, C and D only Skill Check 20

21. Training Records Institutional and Facility Training Important that laboratories identify: Job Training Task-Specific Training 21

22. Stage Description Training needs identified • Procedures for which training is needed are identified Training guides developed • Identification of: • Objectives • Methods • Materials Training is implemented • Trainers are identified • Training is conducted Training outcomes are evaluated • Initial competence evaluation • Evaluation of learner’s experience • Training is documented Training Plan 22

23. Training Categories Initial Training Training that develops trainee’s knowledge and skills to initially perform specific jobs Continuing Training Training that maintains, enhances, or increases the proficiency of employees Retraining The process of providing remediation or tutoring for employees deficient in specific job functions 23

24. Training Methods Lecture Computer based Self-study Observance of demonstrations Practice under supervision Testing of specially-provided samples 24

25. What would you do? Matt Gray, an expert in flow cytometry received training on the FACSCalibur many years ago before quality systems were implemented in his laboratory. His training was not documented. He has trained all other technicians that passed through in his laboratory. In a recent annual audit, the auditor made a citation for the absence of documented evidence of training for Matt Gray. 25

26. Take no action, but document in the action item report to the sponsor that Matt Gray is well trained in this procedure as evidenced by his ability to train other staff members Complete a training log and pre-date it to the time when training was conducted Conceal all records suggesting that Matt Gray is employed at the facility for future audits as there is no documented evidence of training Complete a file note documenting the dates when training was performed and the name of the trainer and then have the file note signed and dated by the Laboratory Director How should the laboratory respond to this finding? 26

27. Competency Application of knowledge, skills, and behaviors in performance Compares employee performance against a standard Competent personnel Quality and accurate results = 27

28. Competency (cont’d) • Verify employees are competent to perform testing and report accurate and timely results • Be able to effectively evaluate competency as well as identify areas for improvement • Be meaningful and instructive Assessments should: 28

29. Competency (cont’d) • Direct observations of specimen handling, processing, and testing • Direct observation of instrument performance, maintenance, and function checks • Monitor the recording and reporting of test results Evaluation Methods: 29

30. Competency (cont’d) • Review of intermediate test results, worksheets, QC records, Proficiency Testing (PT) results, and preventive maintenance records • Assess test performance: Through testing blinded samples or PT samples • Assess problem solving skills Evaluation Methods (cont’d): 30

31. Competency (cont’d) Every 6 months during the first year; and annually thereafter Frequency Retraining and reassessment of competency should be conducted for unsatisfactory performance Records must show what skills were assessed and how those skills were measured 31

32. Competency (cont’d) • Define the areas/sections and activities requiring competency assessment. • Identify methods of competency evaluation. • Determine who will assess competency. • Define the documentation of competency assessment • Develop a competency evaluation SOP. • Specify the following criteria in the SOP: • Evaluation frequency, Evaluation method, and Remedial plan for inadequate performance. Competency Development Program: 32

33. ACTIVITY Enrique works in microbiology. His only duty is to inoculate(set up) cultures List two methods that can be used to evaluate Enrique’s competency Personnel Competency 33

34. ACTIVITY Jill’s competency evaluation was completed last week. The assessment showed she has difficulty differentiating immature white blood cell (WBC) cell lines (e.g., myelocytes, metamyelocytes, etc.) What should Jill’s manager do next? Personnel Competency (cont’d) 34

35. Personnel Competency (cont’d) Assess • Document Re-train(if necessary) • Document • Retraining must occur when problems are identified with employee performance Re-assess(if necessary) • Document 35

36. Records Maintenance Maintenance of the following Records • - Organizational Charts • Position Profiles • Staff Signature Lists • Job Descriptions • Academic/ Professional Records • Professional Licenses • Training and Competency Records 36

37. Records Maintenance (cont’d) Readily available Maintained through the use of a record keeping system Records should be: Maintained for all laboratory employees Reviewed regularly 37

38. Which of the following is the most important asset to an organization? Well defined policies and standards State of the art laboratory equipment Adequately trained staff None of the above Post-Assessment Question #1 38

39. CVs should document evidence of: Theoretical knowledge Training received Practical experience Minimum educational qualifications required for the current job A, B, and C A and C only Post-Assessment Question #2 39

40. Training that maintains, enhances, or increases the proficiency of employees is considered: Initial Training Continuing Training Retraining Post-Assessment Question #3 40

41. Competence compares an employee’s performance against: The Training Plan Standards Policies/procedures B and C Post-Assessment Question #4 41

42. Which of the following methods can be used for competency evaluation? Blinded testing External Quality Assurance (EQA) Quality Control (QC) testing Direct observation Review of temperature monitoring records All of the above Post-Assessment Question #5 42

43. Which of the following is an element of an effective competency development program? Methods for performing competency evaluation Documentation of competency assessment An SOP for competency evaluation All of the above Post-Assessment Question #6 43

44. References • DAIDS Guidelines for Good Clinical Laboratory Practice Standards • Sharp, Elder 2004: Competency assessment in the Clinical Microbiology Laboratory; Clinical Microbiology Reviews • College of American Pathologists Commission on Laboratory Accreditation, Laboratory General Checklist, April 2006 • Clinical and Laboratory Standards Institute. Developing a Training Verification Program. NCCLS document SC16-L, Clinical and Laboratory Standards Institute, Wayne, PA USA, 1996 • CLSI: GP21-A2: Training and Competence Assessment • 42 CFR § 493.1413 • 42 CFR § 493.1451 44

45. Wrap Up 45