Organization and Personnel
Version 5.0, August 2012
This project has been funded in whole or in part with Federal funds from the Division of AIDS (DAIDS), National
Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services,
under contract No. HHSN272201200009C, entitled NIAID HIV and Other Infectious Diseases Clinical Research
Support Services (CRSS).
Objectives



2
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)



3
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?
A.
B.
C.
D.
4
Well defined policies and standards
State of the art laboratory equipment
Adequately trained staff
None of the above
Pre-Assessment Question #2
Curriculum vitae (CVs) should document evidence of:
A.
B.
C.
D.
Theoretical knowledge
Training received
Practical experience
Minimum educational qualifications required for the
current job
E. A, B, and C
F. A and C only
5
Pre-Assessment Question #3
Training that maintains, enhances, or increases the
proficiency of employees is considered:
A. Initial Training
B. Continuing Training
C. Retraining
6
Pre-Assessment Question #4
Competence compares an employee’s performance
against:
A.
B.
C.
D.
7
The Training Plan
Standards
Policies/procedures
B and C
Pre-Assessment Question #5
Which of the following methods can be used for
competency evaluation?
A.
B.
C.
D.
E.
F.
8
Blinded testing
External Quality Assurance (EQA)
Quality Control (QC) testing
Direct observation
Review of temperature monitoring records
All of the above
Pre-Assessment Question #6
Which of the following is an element of an
effective competency development program?
A. Methods for performing competency
evaluation
B. Documentation of competency assessment
C. A Standard Operating Procedure (SOP) for
competency evaluation
D. All of the above
9
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
10
=
Quality
Service
=
Quality
Organization
Organization
11
Organizational
Structure
Laboratory Scope
Job Profiles
Assignment of
Responsibilities
Organizational Charts
Effective way to
communicate
organizational,
employee, and
enterprise
information
12
Should list all
positions and how
they relate to each
other
Allows for
organizing the
laboratory team
with clear
responsibilities,
titles, and lines of
authority
Organizational Charts (cont’d)
Laboratory
Director
Haematologist
Consultant
Laboratory
Manager
QA Manager
Haematology Laboratory
Laboratory Supervisor
Flow Cytometry
Laboratory
Supervisor
Line
Lateral
Staff
Functional
Supervisor
Departmental
Advisory
role. No
Incumbent
Specialist
positions
relationship
authority
and other areas
PCR Laboratory
Supervisor
(Safety Officer)
Techs (2)
Techs (2)
Assistants (2)
Techs (3)
13
Assistant (1)
Laboratory Scope
All testing activities should be listed.
14
Assignment of Responsibilities

15
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
Job Descriptions
Assignment of Responsibilities (cont’d)
16
Lists of the general tasks or functions and
responsibilities of a position
Also includes to whom the position reports
Holds personnel accountable for
performing assigned activities
Should be signed/dated by job-holder and
supervisor
Personnel
The laboratory is required to
demonstrate that its personnel
is adequately…
Trained
Qualified
Competent
Educated
…to perform their assigned
activities.
17
Personnel Records
Maintain records of
Education
Qualifications
Skills
Competency
Training
Applicable licenses
Professional registrations
18
Education and Qualifications
Curricula
Vitae
As well as….
Maintenance
of
Copies of
Certificates
and
Diplomas
19
Transcripts
Valid professional
licenses or
registrations, where
applicable
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?
A.
B.
C.
D.
E.
F.
20
Job descriptions
Salary packages
CVs
Training and competency records
Written warnings
A, C and D only
Training Records
Institutional and Facility
Training
Important
that
laboratories
identify:
Job Training
Task-Specific Training
21
Training Plan
Stage
22
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 Categories
Initial
Training
Continuing
Training
Retraining
23
Training that develops trainee’s knowledge
and skills to initially perform specific jobs
Training that maintains, enhances, or
increases the proficiency of employees
The process of providing remediation or
tutoring for employees deficient in specific
job functions
Training Methods
Lecture
Computer based
Self-study
Observance of
demonstrations
24
Practice under
supervision
Testing of
specially-provided
samples
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?
A. 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
B. Complete a training log and pre-date it to the time when
training was conducted
C. Conceal all records suggesting that Matt Gray is
employed at the facility for future audits as there is no
documented evidence of training
D. 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
26
Competency
Application of knowledge, skills, and behaviors in performance
Compares employee performance against a standard
Competent
personnel
27
=
Quality and
accurate
results
Competency (cont’d)
Assessments should:



28
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
Competency (cont’d)
Evaluation Methods:



29
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
Competency (cont’d)
Evaluation Methods (cont’d):



30
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
Competency (cont’d)
Frequency
Every 6 months during the first year;
and annually thereafter
Retraining and
reassessment of
competency should be
conducted for unsatisfactory
performance
31
Records must show what
skills were assessed and
how those skills were
measured
Competency (cont’d)
Competency Development Program:






32
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.
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
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?
34
Personnel Competency (cont’d)
Assess
35
• Document
Re-train
(if necessary)
• Document
• Retraining must occur when problems are
identified with employee performance
Re-assess
(if necessary)
• Document
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)
Readily available
Records
should be:
Maintained through the use of
a record keeping system
Maintained for all laboratory
employees
Reviewed regularly
37
Post-Assessment Question #1
Which of the following is the most important asset to an
organization?
A.
B.
C.
D.
38
Well defined policies and standards
State of the art laboratory equipment
Adequately trained staff
None of the above
Post-Assessment Question #2
CVs should document evidence of:
A.
B.
C.
D.
Theoretical knowledge
Training received
Practical experience
Minimum educational qualifications required for
the current job
E. A, B, and C
F. A and C only
39
Post-Assessment Question #3
Training that maintains, enhances, or increases the
proficiency of employees is considered:
A. Initial Training
B. Continuing Training
C. Retraining
40
Post-Assessment Question #4
Competence compares an employee’s
performance against:
A.
B.
C.
D.
41
The Training Plan
Standards
Policies/procedures
B and C
Post-Assessment Question #5
Which of the following methods can be used for
competency evaluation?
A.
B.
C.
D.
E.
F.
42
Blinded testing
External Quality Assurance (EQA)
Quality Control (QC) testing
Direct observation
Review of temperature monitoring records
All of the above
Post-Assessment Question #6
Which of the following is an element of an
effective competency development program?
A. Methods for performing competency
evaluation
B. Documentation of competency assessment
C. An SOP for competency evaluation
D. All of the above
43
References







44
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
Wrap Up
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