Non-SMILE Resource

Author: Munyardzi P. Mangwendeza Document Number: Per30-01

Effective (or Post) Date: 5 February 2008
Document Origin Company: BHHRL Lab
BHHRL Lab, Botswana SMILE Approved by: Penny Stevens
Review by Heidi Hanes Review date 17 Feb 2020
SMILE Comments: This document is provided as an example only. It must be revised to
accurately reflect your lab’s specific processes and/or specific protocol requirements. Users are
directed to countercheck facts when considering their use in other applications. If you have any
questions contact SMILE.
 Document No.:
Botswana-Harvard HIV Standard Operating Procedure BHHRL/001PR014
Reference Laboratory
(BHHRL)
Training and Competency
Tel: +267 3902671; Assessment Version : 1
Fax: +267 3901284

Title: Training and Competency Assessment

Name, Title Signature, Date

Prepared By:
Munyaradzi P. Mangwendeza, Quality Manager

Name, Title Signature, Date

Approved By: Dr. Rosemary Musonda, Lab Director

Review Date Revision Date Signature, Date

Annual Review

Location: Copy Number: Location: Copy Number

Master file 1
Director – 2
Distributed To: Dr. Musonda
Director – 3
Dr. Mine
Lab Managers 4
– Mr. S. Moyo
Mrs. K. 5
Makhaola
Lab Co- 6
ordinator

Copy Number: _________

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Confidential Controlled Document

 Document No.:
Botswana-Harvard HIV Standard Operating Procedure BHHRL/001PR014
Reference Laboratory
(BHHRL)
Training and Competency
Tel: +267 3902671; Assessment Version : 1
Fax: +267 3901284

1. General Policy
1.1. BHHRL regards employees as its greatest asset. To this end, the company
maintains an established employee qualification/training program. All personnel
are classified on the basis of appropriate education, training, skills and
experience. Specific personnel are authorized to perform specific tasks. Records
of all training activities are kept in each employee’s file.

2. Purpose
2.1. To establish and define an internal training program and to ensure the
competency of laboratory personnel.
2.2. To emphasize training and training verification as key factors for successful
laboratory operations.
2.3. To ensure that training has taken place with each employee for procedures and
methods that the employee performs.

3. Scope
3.1. The procedure applies to on-the-job training, in-house training and new
employee training. The training is verified and documented.
3.2. The training procedure is applicable to new employees, for the introduction of
new procedures and methods, for retraining of employees, and for reverification
of employee performance.

4. Responsibilities
4.1. Laboratory Manager
4.1.1. Ensures implementation of training procedure,
4.1.2. Ensures resources are allocated for identified training within budgetary
constraints,
4.1.3. Responsible for the evaluation, training and growth of the technical and
quality related skills of employees by establishing training schedule and
rotation for all new employees and by ensuring personnel receive training
and demonstrate competence,
4.1.4. Ensures training is accomplished for all employees,
4.1.5. Submits documentation for completed training for entry to the quality
manager
4.1.6. Identifies training needs and courses and creates budgets.
4.1.7. Ensures proper supervision of trainees until training completed
4.1.8. Authorizes specific personnel to perform particular tasks. Personnel must
provide evidence of having been adequately trained and competent prior to
performing a particular task.

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 Document No.:
Botswana-Harvard HIV Standard Operating Procedure BHHRL/001PR014
Reference Laboratory
(BHHRL)
Training and Competency
Tel: +267 3902671; Assessment Version : 1
Fax: +267 3901284

4.2. Quality Manager:

4.2.1. Trains employees in quality control and quality assurance procedures.
4.2.2. Reviews training received and ensures training files are complete,
4.2.3. Monitors employee performance to identify the need for retraining or
additional continual education,
4.2.4. Identifies training needs resulting from new or revised procedures and
processes.
4.2.5. Maintains qualification/training records for each employee, including
contracted technical personnel. Records include the following:
4.2.5.1. Education
4.2.5.2. Skills and experience
4.2.5.3. Courses/seminars attended
4.2.5.4. Relevant on-the-job training, and retraining as necessary
4.2.5.5. Certification(s)
4.2.5.6. Relevant authorizations
4.2.5.7. Criteria for which authorization is based
4.2.5.8. The name of the confirming authority
4.2.5.9. The date on which authorization and/or competence is confirmed.

4.3. Staff:
4.3.1. Completes required training within specified timeframe;
4.3.2. Becomes and stays knowledgeable in procedures and methods performed.
Note: Employees are responsible for self-training, through reading current
literature, technical papers, publishing technical papers;
4.3.3. Reports all training received and submits documentation for training
received; and
4.3.4. Reads and complies with standards, regulations, policies, procedures, and
work instructions.

5. Procedures
5.1. Principle
5.1.1. Before starting any work related duties, the employee should be familiar
with all work related documents. These documents include procedures, work
instructions, applicable manuals and regulations.
5.1.2. Training requirements are outlined and documented on the basis of the
position description of duties and responsibilities.
5.1.3. New employees should complete all training meant for new employees
before starting work.

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 Document No.:
Botswana-Harvard HIV Standard Operating Procedure BHHRL/001PR014
Reference Laboratory
(BHHRL)
Training and Competency
Tel: +267 3902671; Assessment Version : 1
Fax: +267 3901284

5.1.4. The level of training is determined by the employee’s educational

qualifications, experience, complexity of the test method, and knowledge of
the test method performed.
5.1.5. The employee will not perform any procedure, or method until all
applicable training has been completed and competency demonstrated.
Employees undergoing training are supervised until training is completed
and competency demonstrated.
5.1.6. Employees may request training related to their job.
5.1.7. Upon completion of training submit documentation to the Laboratory
Manager or Quality Manager for filing.
5.1.8. The effectiveness of training is evaluated by but not limited to reviews
performed by management and performance evaluations.
5.1.9. Job requirements, internal audit reports, and corrective action activities
determine employee-training needs. In addition, annual reviews are
conducted with each employee, at which time the employee’s training needs,
as well as the effectiveness of the previous training is discussed. Each
employee is made aware of the relevance and importance of their activities
and how they contribute to the achievement of the quality objectives.
5.1.10. Where personnel certification is required, either by regulatory standards or
by the client, the specified personnel certification requirements are fulfilled
appropriately.
5.1.11. Personnel responsible for opinions and interpretations included in test
reports must have; in addition to the appropriate qualifications, training,
skills, experience, and satisfactory knowledge of the testing carried out, the
following:
5.1.11.1. Relevant knowledge of the technology used for the tests, or the
way they are used or intended to be used.
5.1.11.2. Knowledge of the general requirements expressed in the legislation
and standards.
5.1.11.3. An understanding of the significance of deviations found with
regard to the normal use of the results concerned.
5.1.12. BHHRL maintains current job descriptions for managerial, technical, and
key support personnel involved in tests. Job descriptions, at minimum,
include the following:
5.1.12.1. Responsibilities with respect to performing tests.
5.1.12.2. Responsibilities with respect to the planning of tests and evaluation
of results.
5.1.12.3. Responsibilities for reporting opinions and interpretations.

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Confidential Controlled Document

 Document No.:
Botswana-Harvard HIV Standard Operating Procedure BHHRL/001PR014
Reference Laboratory
(BHHRL)
Training and Competency
Tel: +267 3902671; Assessment Version : 1
Fax: +267 3901284

5.1.12.4. Responsibilities with respect to method modification and

development and validation of new methods.
5.1.12.5. Expertise and experience required.
5.1.12.6. Qualifications and training programs.
5.1.12.7. Managerial duties.

5.2. Training Technique

5.2.1. The training process for technical procedures such as laboratory testing
consists of the following steps:
5.2.1.1. Trainee reads the laboratory procedures, work instructions, or other
applicable documents.
5.2.1.2. Trainee observes demonstration of the procedure by a trainer.
5.2.1.3. Trainee performs the procedure under observation by a trainer.
5.2.1.4. Trainee successfully completes the procedure.
5.2.2. Documentation of these tasks is submitted for filing in the employee’s
training file.
5.2.3. The training process for non-technical procedures includes, but is not
limited to:
5.2.3.1. Reading laboratory procedures,
5.2.3.2. Instructions,
5.2.3.3. Demonstrations,
5.2.3.4. Lectures and discussions,
5.2.3.5. Self study,
5.2.3.6. Computer-based training,
5.2.3.7. Viewing videotapes, and
5.2.3.8. Manufacturer’s training or demonstration.
5.2.4. Documentation of these tasks is submitted for filing in the employee’s
training file.

5.3. Employee assessment

5.4. An employee’s performance is verified by measurement against a defined
performance standard. The measures used to verify an employee’s performance
are assessment tools.
5.5. Assessment tools include the following:
5.5.1. Administration of a written evaluation: written evaluations can be used
in areas where verification of a participant’s knowledge is desired.
Knowledge of theory or principles, problem-solving ability, logical sequence
used, and independent or group decision making may be ascertained.

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Confidential Controlled Document

 Document No.:
Botswana-Harvard HIV Standard Operating Procedure BHHRL/001PR014
Reference Laboratory
(BHHRL)
Training and Competency
Tel: +267 3902671; Assessment Version : 1
Fax: +267 3901284

5.5.2. Observation of procedure, process, or outcome: observation by a trainer

of an employee performing or demonstrating a procedure.
5.5.3. Verification of response to situational problems or calculations related
to the procedure: example circumstances include resolution of a posed and
procedure-related situational problem or recommendation of procedure-
related course of action that is consistent with policies and regulations.
5.5.4. Response to oral queries related to a step or procedure: answers
provided by the employee to questions asked by trainer.
5.5.5. Testing blind QC samples: employees are unaware when blind test
samples are assigned. They appear identical to other samples, are in
routinely used tubes, and are from a similar source. The intent is to provide
simulated samples to measure realistic analytic conditions. This tool assesses
all phases of laboratory performance.
5.5.6. Testing of known samples: participants know and often plan for known
testing events, such as external proficiency surveys and commercially
prepared quality control samples. Samples for quality assurance or quality
control purposes are identified immediately upon receipt in the laboratory.
This tool assesses the analytical phase only.
5.5.7. Testing previously analyzed samples: duplicate or replicate testing
provides accessible internal comparisons and contributes to the validation of
the analytic phase. These sources may be previously tested samples, samples
of known constituents, and already reported proficiency testing samples.
This tool assesses the analytic phase only.

5.6. Documentation of Training Verification includes:

5.6.1. Completion of training checklists prepared internally for all procedures
that an employee performs;
5.6.2. Completion of the procedure with submission of written evidence;
5.6.3. Completion of blind quality control (QC) samples, proficiency surveys,
QC samples, and duplicate testing with submission of results that are within
acceptable criteria limits;
5.6.4. Completion of written evaluations, signing acknowledgment of reading
assigned work instructions;
5.6.5. Attendance sign-in sheets on in-house training, certificates from
manufacturer’s training courses;
5.6.6. Submission of technical papers and handouts of presentations given,
college transcripts for courses taken, licenses and memberships held and
special conferences attended;
5.6.7. Completed paperwork on safety training and orientation,

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Confidential Controlled Document

 Document No.:
Botswana-Harvard HIV Standard Operating Procedure BHHRL/001PR014
Reference Laboratory
(BHHRL)
Training and Competency
Tel: +267 3902671; Assessment Version : 1
Fax: +267 3901284

5.6.8. Memorandums on additional appointments or duties.

5.7. Retraining and Reverification

5.7.1. Retraining:
5.7.1.1. Employees will be retrained whenever significant changes occur in
policies, values, goals, procedures, processes, and methods or
instruments.
5.7.1.2. Employees will be retrained when the level of performance is
unsatisfactory as shown by any of the assessment tools.
5.7.2. Reverification:
5.7.2.1. Reverification occurs whenever employees attend required
courses, continuing education, presentations, workshops, conferences
and scheduled training either in house or manufacturer’s training.
5.7.2.2. Performance reverification occurs whenever proficiency surveys,
blind QC samples, or duplicate testing are submitted.

5.8. Required Training

5.8.1. All employees receive informal “on-the-job” training by the responsible
area supervisor. After a probation period, all new/transferred employees are
evaluated against the position requirements and if performance is found to
be satisfactory, qualification for the applicable position is awarded. Upon
completion of initial training, all personnel performing analysis are required
to prove proficiency prior to analyzing patient samples.
5.8.2. Adequate supervision of testing and calibration staff, including trainees, is
supplied and available at all times. Supervision is familiar with all methods
and procedures, the purpose of each test and/or calibration, and with the
assessment of the test results. If ever there are questions or processes,
equipment, data, etc. in doubt, employees are trained to direct
questions/concerns to the appropriate supervisor.
5.8.3. All laboratory staff members are to undergo training in a number of
procedures, policies and practices upon entry of employment and during
their career with BHHRL. What follows are types of required training.
5.8.3.1. Facility Orientation includes:
5.8.3.1.1. New employees completing required administrative forms as
part of initial processing;
5.8.3.1.2. Introduction to co-workers, personnel policies, working
conditions, daily routine, issuance of manuals, quality
management system and any miscellaneous matters.
5.8.3.1.3. Laboratory overview training.

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Confidential Controlled Document

 Document No.:
Botswana-Harvard HIV Standard Operating Procedure BHHRL/001PR014
Reference Laboratory
(BHHRL)
Training and Competency
Tel: +267 3902671; Assessment Version : 1
Fax: +267 3901284

5.8.3.2. New-Employee Training often includes:

5.8.3.2.1. Quality Management System: Quality Assurance including
annual training on quality control (QC), quality assurance (QA),
the BHHRL Quality Management System (QMS) and related
procedures
5.8.3.2.2. Health and Safety Training may include the topics of:
5.8.3.2.2.1. Blood-borne pathogen standard,
5.8.3.2.2.2. Universal precautions (e.g. hand washing and aids
awareness),
5.8.3.2.2.3. Post Exposure Prophylaxis
5.8.3.2.2.4. Personal protective equipment,
5.8.3.2.2.5. Fire training,
5.8.3.2.2.6. Emergency evacuation
5.8.3.2.2.7. Safety practices in the laboratory
5.8.3.2.2.8. Hazardous Waste Management that includes annual
training on handling, storage, and disposal of hazardous
materials
5.8.3.3. On-the-job training, national training courses and manufacturer’s
training.
5.8.3.4. Training on policies, regulations, procedures, methods, and
instruments.
5.8.3.5. Other Training
5.8.3.5.1. Often Laboratory staff has an opportunity to attend auxiliary
training when available and resources permitting. This type of
training includes:
5.8.3.5.1.1. Attendance at presentations, courses and
conferences;
5.8.3.5.1.2. Computer courses such as in-house training,
instructional, and manufacturer’s training on software in use.

6. Quality Assurance and Quality Control

6.1. Training manuals should be available for training the relevant staff members.
6.2. Training should be planned, coordinated and authorised.
6.3. All documentation should be kept as proof of training
6.4. Competent supervisors should be used in the training process.

7. Records
7.1. Training Records

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Confidential Controlled Document

 Document No.:
Botswana-Harvard HIV Standard Operating Procedure BHHRL/001PR014
Reference Laboratory
(BHHRL)
Training and Competency
Tel: +267 3902671; Assessment Version : 1
Fax: +267 3901284

7.2. Job Descriptions

7.3. Assessment records

8. Co-Applicable Documents
8.1. Orientation and Training Manual
8.2. Competency Assessment Forms
8.3. Training Checklist and Performance Standard

9. References
9.1. BHHRL Quality Manual

Revision History:
Revision Revision Revised By: Brief description of revision:
Level: Date:

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