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Organization and Personnel. Version 5.0, August 2012. 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. Objectives (cont’d).

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organization and personnel

Organization and Personnel

Version 5.0, August 2012

objectives
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.
objectives cont d
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.
pre assessment question 1
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

pre assessment question 2
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

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

6

pre assessment question 5
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

pre assessment question 6
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

organizations and personnel
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

=

=

organization
Organization

Laboratory Scope

Job Profiles

Organizational Structure

Assignment of Responsibilities

organizational charts
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

organizational charts cont d

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

laboratory scope
Laboratory Scope

All testing activities should be listed.

14

assignment of responsibilities
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
assignment of responsibilities cont d
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

personnel
Personnel

The laboratory is required to demonstrate that its personnel is adequately…

Trained

Qualified

Competent

Educated

…to perform their assigned activities.

17

personnel records
Personnel Records

Maintain records of

Education

Qualifications

Skills

Training

Competency

Applicable licenses

Professional registrations

slide19

As well as….

Curricula Vitae

Education and Qualifications

Maintenance of

Valid professional licenses or registrations, where applicable

Transcripts

Copies of Certificates and Diplomas

skill check
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

training records
Training Records

Institutional and Facility Training

Important that laboratories identify:

Job Training

Task-Specific Training

21

training plan

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

training categories
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

training methods
Training Methods

Lecture

Computer based

Self-study

Observance of demonstrations

Practice under supervision

Testing of specially-provided samples

24

what would you do
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

how should the laboratory respond to this finding
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

competency
Competency

Application of knowledge, skills, and behaviors in performance

Compares employee performance against a standard

Competent personnel

Quality and accurate results

=

27

competency cont d
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

competency cont d1
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

competency cont d2
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

competency cont d3
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

competency cont d4
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

personnel competency
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

personnel competency cont d
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

personnel competency cont d1
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

records maintenance
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

records maintenance cont d
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

post assessment question 1
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

post assessment question 2
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

post assessment question 3
Training that maintains, enhances, or increases the proficiency of employees is considered:

Initial Training

Continuing Training

Retraining

Post-Assessment Question #3

40

post 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

Post-Assessment Question #5

42

post assessment question 6
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

references
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

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