Organization and Personnel

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).

Organization and Personnel

Version 5.0, August 2012

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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

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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.

Objectives (cont’d)

Pre-Assessment Question #1

Which of the following is the most important asset to an organization?

A. Well defined policies and standardsB. State of the art laboratory equipmentC. Adequately trained staffD. None of the above

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Curriculum vitae (CVs) should document evidence of:

A. Theoretical knowledgeB. Training receivedC. Practical experienceD. Minimum educational qualifications required for the

current jobE. A, B, and CF. A and C only

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Training that maintains, enhances, or increases the proficiency of employees is considered:

A. Initial TrainingB. Continuing TrainingC. Retraining

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Competence compares an employee’s performance against:

A. The Training PlanB. StandardsC. Policies/proceduresD. B and C

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Which of the following methods can be used for competency evaluation?

A. Blinded testingB. External Quality Assurance (EQA)C. Quality Control (QC) testingD. Direct observationE. Review of temperature monitoring recordsF. All of the above

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Which of the following is an element of an effective competency development program?

A. Methods for performing competency evaluation

B. Documentation of competency assessmentC. A Standard Operating Procedure (SOP) for

competency evaluationD. All of the above

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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.

Organizations and Personnel

Quality People

Quality Organization

Quality Service= =

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Organization

Organizational Structure

Laboratory Scope

Job Profiles Assignment of Responsibilities

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Organizational Charts

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

Effective way to communicate organizational, employee, and

enterprise information

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Haematologist Consultant

Organizational Charts (cont’d)

Laboratory Director

Laboratory Manager

QA Manager

Flow CytometryLaboratory Supervisor

Techs (2)

PCR Laboratory Supervisor

(Safety Officer)

Techs (3) Assistant (1)

Haematology LaboratoryLaboratory Supervisor

Techs (2) Assistants (2)

LineSupervisor - Incumbent

LateralDepartmental relationship

StaffAdvisory role. No

authority

FunctionalSpecialist positions

and other areas

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Laboratory Scope

All testing activities should be listed.

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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

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Assignment of Responsibilities (cont’d)Jo

b D

escr

iptio

nsLists 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

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Personnel

Qualified

Trained

Educated

Competent

The laboratory is required to demonstrate that its personnel

is adequately…

…to perform their assigned activities.

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Personnel Records

Competency

Skills

Qualifications

Training

Education

Maintain records of

Applicable licensesProfessional registrations

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Maintenance of

Curricula Vitae

TranscriptsCopies of

Certificates and

Diplomas

Education and Qualifications

As well as….

Valid professional licenses or registrations, where applicable

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Skill CheckThe 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. Job descriptionsB. Salary packagesC. CVsD. Training and competency recordsE. Written warningsF. A, C and D only

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Training Records

Institutional and Facility Training

Job Training

Task-Specific Training

Important that

laboratories identify:

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Training Plan

• Initial competence evaluation• Evaluation of learner’s experience• Training is documented

Training outcomes are evaluated

• Trainers are identified• Training is conductedTraining is implemented

• Identification of:• Objectives• Methods• Materials

Training guides developed

• Procedures for which training is needed are identifiedTraining needs identified

DescriptionStage

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Training Categories

Initial Training Training that develops trainee’s knowledge

and skills to initially perform specific jobs

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

Continuing Training

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Training Methods

Testing of specially-provided

samples

Observance of demonstrations

Self-study

Practice under supervision

LectureComputer based

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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.

What would you do?

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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

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Competency

Competent personnel = Quality and

accurate results

Application of knowledge, skills, and behaviors in performance

Compares employee performance against a standard

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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:

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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:

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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):

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Every 6 months during the first year; and annually thereafterFrequency

Retraining and reassessment of

competency should be conducted for unsatisfactory

performance

Records must show what skills were assessed and

how those skills were measured

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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:

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Personnel Competency

ACTIVITYEnrique works in microbiology. His only duty is to inoculate(set up) cultures • List two methods that can be

used to evaluate Enrique’s competency

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Personnel Competency (cont’d)

ACTIVITYJill’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?

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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

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Records Maintenance

- Organizational Charts- Position Profiles- Staff Signature Lists- Job Descriptions- Academic/ Professional Records- Professional Licenses- Training and Competency Records

Maintenance of the following Records

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Records Maintenance (cont’d)

Readily available

Maintained through the use of a record keeping system

Maintained for all laboratory employees

Records should be:

Reviewed regularly

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Post-Assessment Question #1

Which of the following is the most important asset to an organization?

A. Well defined policies and standardsB. State of the art laboratory equipmentC. Adequately trained staffD. None of the above

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CVs should document evidence of:

A. Theoretical knowledgeB. Training receivedC. Practical experienceD. Minimum educational qualifications required for

the current jobE. A, B, and CF. A and C only

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Training that maintains, enhances, or increases the proficiency of employees is considered:

A. Initial TrainingB. Continuing TrainingC. Retraining

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Competence compares an employee’s performance against:

A. The Training PlanB. StandardsC. Policies/proceduresD. B and C

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Which of the following methods can be used for competency evaluation?

A. Blinded testingB. External Quality Assurance (EQA)C. Quality Control (QC) testingD. Direct observationE. Review of temperature monitoring recordsF. All of the above

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Which of the following is an element of an effective competency development program?

A. Methods for performing competency evaluation

B. Documentation of competency assessmentC. An SOP for competency evaluationD. All of the above

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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

References

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Wrap Up

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Documents

Organization and Personnel