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Botswana-Harvard HIV Document No.:
Reference Laboratory BHHRL/001PL01
(BHHRL)
Quality Manual
Tel: +267 3902671;
Fax: +267 3901284 Version : 1.0

Title:
QUALITY MANUAL

Name, Title Signature, Date

Prepared By:
Munyaradzi P. Mangwendeza, Quality Manager

Name, Title Signature, Date

Approved By: Dr. Rosemary Musonda, Laboratory 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 –
Mr. S. Moyo 4
Mrs. K. 5
Makhaola
Lab Co-ordinator 6

Copy Number: _________

Signed, Quality Manager : Date :

Effective Date :01/03/2008 Page 1 of 21
Botswana-Harvard HIV Document No.:
Reference Laboratory BHHRL/001PL01
(BHHRL)
Quality Manual
Tel: +267 3902671;
Fax: +267 3901284 Version : 1.0

Table of Contents Page

1. Introduction 3
2. References 3
3. Terms And Definitions 3
4. Management Requirements 4
4.1. Organization 4
4.2. Management System 6
4.3. Document Control 7
4.4. Review of Contracts, Orders and Research Project Proposals. 8
4.5. Referral of Laboratory Testing 8
4.6. Purchasing Services And Supplies 9
4.7. Service To The Client 9
4.8. Complaints 10
4.9. Control Of Nonconforming Work 10
4.10. Improvement 11
4.11. Corrective Action 11
4.12. Preventive Action 11
4.13. Control Of Records 12
4.14. Internal Audits 12
4.15. Management Reviews 13
5. Technical Requirements 13
5.1. General 13
5.2. Personnel 13
5.3. Accommodation And Environmental Conditions 14
5.4. Test Methods and Method Validation 15
5.5. Equipment 17
5.6. Measurement Traceability 18
5.7. Sampling 18
5.8. Handling and Transport of Samples 19
5.9. Assuring The Quality Of Test And Calibration Items 19
5.10. Reporting Of Results 20
6. Appendices 21

Signed, Quality Manager : Date :

Effective Date :01/03/2008 Page 2 of 21
Botswana-Harvard HIV Document No.:
Reference Laboratory BHHRL/001PL01
(BHHRL)
Quality Manual
Tel: +267 3902671;
Fax: +267 3901284 Version : 1.0

1. Introduction
1.1. The Botswana Harvard HIV Reference Laboratory (BHHRL) is a medical
testing laboratory involved in both diagnostic and research testing. The
management of BHHRL understands and recognizes the importance of the work
carried out by the institution and has thus placed great value in quality
management. In this regard, management has developed a Quality Management
System based on the international standard ISO/IEC 17025:2005 (BOS
ISO/IEC 17025:2005 as adopted by the Botswana Bureau of Standards).
1.2. The quality management system is defined and documented in this Quality
Manual and other documents that make up the Quality Management System
documents. Documentation of the Quality Management System used at BHHRL
follows a 4-tier pyramid made up of Quality Manual, Policies and Procedures,
Work Instructions and Forms/Records.
1.3. The Quality Manual itself defines the Quality Management System, states
responsibilities of the personnel affected by the system and makes reference to
the standard operating procedures for all the activities that make up the
Quality Management System.
1.4. The Quality Manual will also be used to inform those who use our services of our
Quality Management System and the various controls used to assure testing
service quality.
1.5. The Quality Manual shall be reviewed annually and revised when and as
necessary so as to be up to date and reflect the Quality Management System that
will be currently in use. It shall be issued on controlled copy basis to all those
affected by the Quality Management System and on an uncontrolled copy basis
to suppliers and those who use our services.
1.6. For effectiveness, the Quality Manual should be used in conjunction with all the
documents it makes reference to as well as others that make up the Quality
Management System documents.

2. References
2.1. BOS ISO/IEC 17025 Standard – General Requirements for the Competence of
Testing and Calibration Laboratories.
2.2. ISO 9000 - Quality Management Systems -- Fundamentals and Vocabulary

3. Terms and Definitions

3.1. Refer to document: BHHRL/001PR015 Quality Management System Terms and
Definitions

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Botswana-Harvard HIV Document No.:
Reference Laboratory BHHRL/001PL01
(BHHRL)
Quality Manual
Tel: +267 3902671;
Fax: +267 3901284 Version : 1.0

4. Management Requirements
4.1. Organization
4.1.1. The BHHRL is constituted by the Botswana Harvard AIDS Institute
Partnership for HIV Research and Education. Botswana Harvard Partnership
and the MoH diagnostic laboratory established to support the National anti
retroviral programme (MASA). The BHHRL has been established as part of
the collaborative research and training initiative between the Botswana
Government and the Harvard AIDS Institute which was established in 1996.
4.1.2. BHHRL has legal responsibility over its activities and carries out its
activities in a manner that meets the requirements of the BOS ISO/IEC
17025:2005 International Standard making sure clients’ needs are fulfilled as
well as those of all regulatory authorities and organizations. This Quality
Management System covers all work carried out at the BHHRL main
facilities as well as all the clinics situated in the country that carry out
activities for and under oversight by BHHRL.
4.1.3. The laboratory is not part of any other organization that carries out work
other than medical testing and HIV research work and the responsibilities of
all key personnel in the organization that have an involvement or influence
on the testing activities of the laboratory, are clearly defined to prevent any
potential conflict of interest.
4.1.4. The laboratory has technical and managerial personnel who have the
authority and resources needed to carry out their duties which include
implementing, maintaining and improving the Quality Management System
as well as identifying the occurrence of departures from the Quality
Management System or from the procedures for performing test and to
initiate actions to prevent or minimize such departures.
4.1.5. The Terms and Conditions of Service of BHHRL have been developed to
ensure that personnel do not have undue internal and external commercial,
financial and other pressures and influences that may adversely affect the
quality of their work. They have also been developed to ensure that BHHRL
and its personnel are not involved in activities that would diminish
confidence in BHHRL’s competence, impartiality, judgement or operational
integrity.
4.1.6. It is the policy of BHHRL to protect the confidential information of those
involved in our activities including protecting electronic storage and storage
of results. To this end all employees are required to sign a confidentiality
document on employment.
4.1.7. BHHRL has in place an organogram that defines the organization and
management structure of the laboratory, relationships with other

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Reference Laboratory BHHRL/001PL01
(BHHRL)
Quality Manual
Tel: +267 3902671;
Fax: +267 3901284 Version : 1.0

organizations as well as the relationship between Quality Management

System, technical operations and support services.
4.1.8. BHHRL has in place an authority matrix which specifies the
responsibility, authority and interrelationships of all personnel who manage
perform or verify work affecting the quality of test.
4.1.9. BHHRL executive management has appointed a technical manager who is
known as the Laboratory Manager who has overall responsibility for the
technical operations and provision of the resources needed to ensure the
required quality of laboratory operations. The Laboratory Manager ensures
that section 5 of the Quality Manual is implemented and maintained.
4.1.10. BHHRL executive management has appointed a Quality Manager who
has the defined responsibility and authority for ensuring the that the Quality
Management System related to quality is understood, implemented and
followed at all times by all personnel and has direct access to the highest
level of management at which decisions are made on laboratory policies and
resources. The Quality manager ensures that section 4 of the Quality Manual
is implemented and maintained.
4.1.11. BHHRL management ensures that appropriate communication processes
are established within the organization, that communication takes place
regarding the effectiveness of the management system, that its personnel are
aware of the relevance and importance of their activities and how they
contribute to the achievement of the objectives of the quality management
system and that staff are encouraged to communicate to their supervisors all
matters that impact adversely on the quality management process.
4.1.12. Communication channels available to BHHRL staff are, but not limited
to, meetings, memos, email, notices on boards, and confidential suggestion
box.
4.1.13. To ensure that activities flow in an uninterrupted manner, BHHRL
management has appointed deputies for key managerial personnel.
Management also provides adequate supervision for testing staff including
those on training, by personnel familiar with methods and procedures,
purpose of the test and with assessment of the test.
4.1.14. Refer to:
4.1.14.1. BHHRL Terms and Conditions of Service
4.1.14.2. BHHRL/001PR05 BHHRL Organogram

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Botswana-Harvard HIV Document No.:
Reference Laboratory BHHRL/001PL01
(BHHRL)
Quality Manual
Tel: +267 3902671;
Fax: +267 3901284 Version : 1.0

4.2. Management System

4.2.1. The Quality Manual is the principal document that defines the Quality
Management System of BHHRL. The Quality Management System
policies, procedures, and instructions are documented to establish and
maintain continuity of each activity or function affecting quality. Quality
Management ensures that quality documentation is communicated to,
understood by and readily available to appropriate personnel for reference
and implementation.
4.2.2. The Quality Management System is meant to:
4.2.2.1.Identify the processes needed for the Quality Management System
4.2.2.2.Determine the sequence and interaction of the processes needed in the
Quality Management System
4.2.2.3.Determine criteria and methods required to ensure the effective
operation and management of these processes
4.2.2.4.Ensure the availability of resources and information necessary to
support the operation and monitoring of these processes
4.2.2.5.Monitor measure and analyze these processes and implementing
actions necessary to achieve planned results and continual
improvement.
4.2.3. All the procedures for BHHRL are continually improved in accordance
with the requirements of the standard and laboratory management
communicates to the organization the importance of meeting customer
requirements as well as statutory and regulatory requirements.
4.2.4. Refer to:
4.2.4.1.Appendix 1 – BHHRL Organogram
4.2.4.2.Appendix 2 – Table of Deputies

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Botswana-Harvard HIV Document No.:
Reference Laboratory BHHRL/001PL01
(BHHRL)
Quality Manual
Tel: +267 3902671;
Fax: +267 3901284 Version : 1.0

Quality Policy Statement

BHHRL management is committed to the provision of medical laboratory testing services

that are of high international standards in line with the principles of good professional
laboratory practice. Management is also committed to the provision of accurate, reliable,
credible, relevant and timely laboratory results obtained from tests that are always carried
out in accordance with stated procedures and client requirements while complying with the
requirements of the ISO/IEC 17025:2005 International Standard. Management undertakes
to periodically review the performance of the Quality Management System and quality
objectives to ensure their effectiveness, continuing relevance and suitability in ensuring
production of high quality laboratory results. It is, however, the responsibility of all BHHRL
personnel to familiarize themselves with the content and requirements of the Quality
Management System documentation and implement the policies and procedures as laid
down, in all their work processes.

4.2.5. The requirements of the Quality Management System will be met by

documenting specific quality practices and activities for all processes,
including meeting contractual requirements, understanding and meeting
customer needs, and with emphasis on problem prevention. Changes to the
Quality Management System will be made as conditions or services change
or mature. Written quality and audit plans will be prepared for these changes
which will be consistent with all other requirements of the quality
management system.
4.2.6. Refer to:
4.2.6.1. Appendix 3 – Quality Management System Objectives

4.3. Document Control

4.3.1. BHHRL recognizes the importance of regulating the information made
available to its personnel for use in their day to day work. As a result,
management has established and maintains a procedure to control all
documents, internally generated and from external sources, that form part of
the Quality Management System documentation. These include documents
of external origin such as regulations, standards, other normative documents,
test methods as well as drawings, specifications, instructions and manuals.
4.3.2. Refer to: Document No:
4.3.2.1.BHHRL/001PR01 Document Control and Management.

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Botswana-Harvard HIV Document No.:
Reference Laboratory BHHRL/001PL01
(BHHRL)
Quality Manual
Tel: +267 3902671;
Fax: +267 3901284 Version : 1.0

4.4. Review of Contracts, Orders and Research Project Proposals.

4.4.1. BHHRL ensures that the contract, order and research project proposal
review is conducted in a practical and efficient manner, and the effect of
financial, legal and time schedule aspects are taken into account. For internal
clients the review is done in a simplified manner.
4.4.2. The review of capability verifies that the laboratory possesses the
necessary physical, personnel, and information resources, and that the
laboratory personnel have the skills and expertise necessary for the
performance of the tests in question.
4.4.3. The review may encompass results of earlier participation in proficiency
testing and/or running of trial test programs using samples of known values
in order to determine uncertainties of measurement, limits of detection,
confidence limits e.t.c.
4.4.4. The review also covers any work that is subcontracted by the laboratory
and if the contract needs amendment after work has commenced, the same
contract review process is repeated and any amendments communicated to
all affected personnel.
4.4.5. Refer to: Document No:
4.4.5.1.BHHRL/001PR02 Review of Contracts, Orders and Research Project
Proposals.

4.5. Referral of Laboratory Testing

4.5.1. It is the policy of BHHRL that any work that is subcontracted is placed
with competent subcontractors that are on the Approved Supplier List and
are in compliance with this Quality Management System and requirements
of ISO/IEC 17025:2005 or ISO/IEC 15189 International Standards.
4.5.2. Subcontractors are evaluated, selected and monitored by management of
BHHRL except in cases where the client or regulatory agency specifies
which subcontractor is to be used.
4.5.3. Where any work has been subcontracted, BHHRL shall not under any
circumstances report that the work has been carried out by itself.
4.5.4. Refer to: Documents No:
4.5.4.1.BHHRL/001PR04 Referral of Laboratory Testing
4.5.4.2.BHHRL/010PR01 Purchasing and Receipt of Services and Materials
4.5.4.3.BHHRL/001PR02 Review Of, Contracts, Orders and Research
Project Proposals.
4.5.4.4.BHHRL/010PR04 Approved Supplier List

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Botswana-Harvard HIV Document No.:
Reference Laboratory BHHRL/001PL01
(BHHRL)
Quality Manual
Tel: +267 3902671;
Fax: +267 3901284 Version : 1.0

4.6. Purchasing Of Services And Supplies

4.6.1. BHHRL uses only such services and supplies that are of the quality
needed to sustain confidence in the results of tests carried out. To assure this,
management has established policies and procedures for the selection and
purchasing of services and supplies it uses that affect the quality of the tests.
The procedures include purchasing, reception and storage of reagents and
consumable materials relevant to test.
4.6.2. Purchased supplies and consumable materials that affect the quality are
not used until they have been inspected or otherwise verified as complying
with standard specifications or requirements defined in the methods for test
concerned.
4.6.3. All suppliers of critical supplies/services that may affect the quality of
testing are evaluated and records maintained. Supplier status is maintained in
through the use of the Approves Supplier List.
4.6.4. Refer to: Documents No:
4.6.4.1.BHHRL/010PR01 Purchasing and Receipt of Services and Materials
4.6.4.2.BHHRL/010PR03 Approved Supplier List,
4.6.4.3.BHHRL/010PR02 Inventory Control

4.7. Service to the Client

4.7.1. BHHRL afford clients, or their representatives, cooperation to facilitate
clarification of the client’s request and to monitor the performance of the
laboratory in relation to the work performed, provided confidentiality is
ensured to other clients. Such cooperation may include, but is not limited to,
providing reasonable access to relevant areas of the laboratory for the
witnessing of test performed and preparing, packaging and dispatching of
tests samples needed by the client for verification purposes.
4.7.2. Client observation of testing is acceptable to the extent that it does not
interfere with the testing process. Personnel should report to the Laboratory
Manager when observations become intrusive.
4.7.3. The Laboratory Manager is the point of contact for the maintenance of
contacts with client, providing advice and guidance in technical matters and
opinions and interpretations based on results. The Laboratory Manager also
informs the client of any delays or major deviations in the performance of
test.
4.7.4. The Laboratory and Quality Manager encourage and obtain feedback, both
negative and positive, from clients for the purposes of improving the Quality
Management System.

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Botswana-Harvard HIV Document No.:
Reference Laboratory BHHRL/001PL01
(BHHRL)
Quality Manual
Tel: +267 3902671;
Fax: +267 3901284 Version : 1.0

4.7.5. Refer to: Document No:

4.7.5.1.BHHRL/001PR06 Handling Complaints/Suggestions and
Monitoring Client and Staff Satisfaction

4.8. Complaints
4.8.1. BHHRL has established a policy and procedure for the resolution of
complaints received form clients or other parties. Records of all complaints
are kept as well as those for the investigations and corrective actions
instituted.
4.8.2. The Quality Manager monitors complaints and any other discrepancies
that may raise doubt about compliance with policies and procedures. If it is
determined that sufficient cause exists, an audit of those areas of activities
involved will be performed according to the internal audit procedures.
4.8.3. Refer to : Document No:
4.8.3.1.BHHRL/001PR08 Corrective and Preventive Actions and Continual
Improvement
4.8.3.2.BHHRL/001PR06 Handling Complaints/Suggestions and
Monitoring Client and Staff Satisfaction,
4.8.3.3.BHHRL/001PR08 Corrective and Preventive Actions and Continual
Improvement
BHHRL/001PR011 Internal Audits.
4.8.3.4.BHHRL/001PR06 Handling Complaints/Suggestions and
Monitoring Client and Staff Satisfaction

4.9. Control of Nonconforming Testing Work

4.9.1. Identification of nonconforming test work or problems with the Quality
Management System can occur at various points with in the Quality
Management System and technical operations such as customer complaints,
quality control, instrument calibration, checking of consumable materials,
staff observations or supervision, test report, management review and
internal and external audits.
4.9.2. BHHRL has thus established and maintains a Control of Nonconforming
Work SOP that is implemented when any aspect of its testing or the results
of its work, do not conform to its own procedures or the agreed requirements
of the client.
4.9.3. Where the evaluation indicates that the nonconforming work could recur
or that there is doubt about the compliance of the laboratory’s operations
with its own procedure, the Corrective and Prevention Action SOP is

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Reference Laboratory BHHRL/001PL01
(BHHRL)
Quality Manual
Tel: +267 3902671;
Fax: +267 3901284 Version : 1.0

promptly followed to identify the root causes of the problem and to eliminate
them.
4.9.4. Refer to; Document No:
4.9.4.1.BHHRL/001PR07 Control of Nonconforming Work,
4.9.4.2.BHHRL/001PR08 Corrective and Preventive Actions and Continual
Improvement

4.10. Improvement
4.10.1. BHHRL continually improve the effectiveness of its Quality Management
System through the use of the quality policy, quality objectives, and audit
results, analysis of data, corrective actions, preventive actions and
management review.
4.10.2. Refer to: Document No:
4.10.2.1. BHHRL/001PR08 Corrective and Preventive Actions and
Continual Improvement

4.11. Corrective Action

4.11.1. BHHRL’s quality management system is set towards the prevention of
nonconformities. The Corrective and Preventive Action SOP is thus utilized
for implementing corrective action when nonconforming work or departures
from the policies and procedures in the Quality Management System or
technical operations have been identified. The procedure designates
appropriate authorities to implement corrective action.
4.11.2. If the identification of nonconformities or departures casts doubts on the
laboratory’s compliance with its own policies and procedures, or its
compliance with the ISO/IEC 17025:2005 International Standard, the
appropriate areas of activity are promptly audited in accordance with the
Internal Audit SOP.
4.11.3. Refer to: Document No:
4.11.3.1. BHHRL/001PR08 Corrective and Preventive Actions and
Continual Improvement
BHHRL/001PR011 Internal Audits.

4.12. Preventive Action

4.12.1. Needed improvement and potential sources of non-conformances, either
technical or with the Quality Management System are identified as per the
SOP on Continual Improvement and/or the Corrective and Preventive
Action. If preventive action is required, action plans are developed,
implemented and monitored to reduce the likelihood of the occurrence of

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Reference Laboratory BHHRL/001PL01
(BHHRL)
Quality Manual
Tel: +267 3902671;
Fax: +267 3901284 Version : 1.0

such nonconformities and take advantage of the opportunities for

improvement.
4.12.2. Preventive action is a pro-active process to identify opportunities for
improvement rather than a reaction to the identification of problems or
complaints and may involve analysis of data, including trend and risk
analysis and proficiency testing results.
4.12.3. Refer to : Document No:
4.12.3.1. BHHRL/001PR08 Corrective and Preventive Actions and
Continual Improvement

4.13. Control Of Records

4.13.1. BHHRL has established and maintains a Control of Records SOP to
manage quality and technical records. Such records are maintained to
provide evidence of conformance to requirements and of effective operation
of the Quality Management System. The SOP ensures identification,
collection, indexing, access, storage, maintenance and disposal of quality
and technical records. Quality records also include reports from internal
audits and management reviews as well as corrective and preventive action
records.
4.13.2. All records are held secure and in confidence and procedures are
implemented to protect and back-up records stored electronically and to
prevent unauthorized access to or amendments of these records.
4.13.3. All records are retained for the defined time.
4.13.4. Refer to: Document No:
4.13.4.1. BHHRL/001PR012 Records Control and Management.

4.14. Internal Audits

4.14.1. BHHRL periodically and in accordance with a predetermined schedule
and procedure, conduct internal audits of activities to verify that operations
continue to comply with requirements of the Quality Management System
and ISO/IEC 17025:2005 standard. The internal audit program is designed to
address all elements of the Quality Management System including the
testing activities.
4.14.2. It is the responsibility of the Quality Manager to plan and organize audits
as required by the schedule and requested by management and audits are
carried out by trained and qualified personnel who are independent of the
activity being audited.
4.14.3. Refer to: Document No:
4.14.3.1. BHHRL/001PR011 Internal Audits.

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Reference Laboratory BHHRL/001PL01
(BHHRL)
Quality Manual
Tel: +267 3902671;
Fax: +267 3901284 Version : 1.0

4.15. Management Reviews

4.15.1. BHHRL management periodically, and in accordance with a
predetermined schedule and procedure, conducts a review of the laboratory’s
Quality Management System and testing activities to ensure their continuing
suitability and effectiveness and to introduce necessary changes and
improvements. These reviews are held at a minimum of at least once
annually.
4.15.2. The reviews take account of customer feedbacks, complaints, changes in
type and volume of work, the results of comparisons and proficiency tests,
assessments by external bodies, the outcome of recent internal audits,
corrective and preventive actions, reports from managerial and supervisory
personnel, the suitability of policies and procedures, recommendations for
improvement and any other factors such as quality control activities,
resources and staffing.
4.15.3. Records of management reviews are maintained and actions are carried
out within an appropriate and agreed time period.
4.15.4. Refer to: Document No:
4.15.4.1. BHHRL/001PR013 Management Review.

5. Technical Requirements
5.1. General
5.1.1. BHHRL recognizes that many factors determine the correctness and
reliability of the tests performed by the laboratory. These include
contributions from human factors, accommodation and environmental
conditions, test and calibration methods and method validation, equipment,
measurement traceability, sampling and handling of samples.
5.1.2. The extent to which the factors contribute to the total uncertainty of
measurements differs considerably between types of tests. BHHRL takes
into account these factors in developing test procedures, in training and
qualification of personnel and in selection and calibration of the equipment it
uses.
5.1.3. Refer to: Document No:
5.1.3.1.BHHRL/001PR016 Accommodation and Environmental Conditions
and Process Control.

5.2. Personnel
5.2.1. BHHRL management ensures the competency of all who operate specific
equipment, who perform tests, evaluate results and sign reports. Staff
undergoing training is adequately and appropriately supervised. Personnel

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Quality Manual
Tel: +267 3902671;
Fax: +267 3901284 Version : 1.0

performing tasks are qualified on the basis of appropriate education, training,

experience and /or demonstrated skills as required.
5.2.2. The Laboratory Manager formulates goals with respect to education and
skills of the laboratory personnel. Training needs are identified and any
necessary training is provided as per the Training SOP. Training programs
are relevant to present and anticipated tasks of the laboratory and the
effectiveness of the training is evaluated.
5.2.3. BHHRL uses personnel who are contracted to the laboratory.
5.2.4. The Laboratory Manager ensures that contractual, additional technical
employees and key support personnel are adequately supervised and work in
accordance with the laboratory’s Quality Management System. The
Laboratory Manager authorizes specific personnel to perform particular
types of tests, to issue test reports, to give opinions and interpretation and to
operate particular types of equipment.
5.2.5. The Quality Manager maintains current job descriptions for managerial,
technical and key support personnel involved in testing. The Quality
Manager maintains records of relevant competence, educational and
professional qualification, training, skills, and experience of all technical
personnel. This information is readily available and includes the date on
which authorization and/or competence is confirmed and criteria on which
the authorization is based and the conforming authority.
5.2.6. Refer to: Document No:
5.2.6.1.BHHRL/001PR014 Training and Competency Assessment
5.2.6.2. BHHRL/009PL01 Health and Safety Manual

5.3. Accommodation and Environmental Conditions

5.3.1. BHHRL management ensures that the environment in which testing is
performed does not invalidate the results or adversely affect the required
quality of any measurement.
5.3.2. Sampling and testing performed at sites other that the permanent facility
are performed under the same specifications. The technical requirements for
accommodation and environmental conditions that can affect the results of
the tests are recorded in method SOPs.
5.3.3. Management ensures that there are effective separations between
neighbouring areas in which there are in compatible activities and that
measures are taken to prevent cross-contamination.
5.3.4. Refer to: Document No:
5.3.4.1.BHHRL/001PR016 Accommodation and Environmental Conditions
and Process Control.

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Effective Date :01/03/2008 Page 14 of 21
Botswana-Harvard HIV Document No.:
Reference Laboratory BHHRL/001PL01
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Quality Manual
Tel: +267 3902671;
Fax: +267 3901284 Version : 1.0

5.3.4.2.BHHRL/009PR02 Housekeeping
5.3.4.3.BHHRL/009PL01 Health and Safety Manual.
5.3.4.4.Appendix 5 – List of Technical SOPs

5.4. Test Methods and Method Validation

5.4.1. BHHRL uses appropriate methods and procedures for all tests within its
scope including sampling, handling, transport, storage and preparation of
items to be tested and where appropriate, an estimation of the measurement
uncertainty as well as statistical techniques for analysis of test data.
5.4.2. BHHRL maintains instructions on the use and operation of all relevant
equipment and on the handling and preparation of items for testing where the
absence of such instructions could jeopardize the results of tests. All
instructions, standards, manuals and reference data relevant to the work of
the laboratory are maintained current and are made available to personnel.
Deviation from test methods occur only if the deviation is documented,
technically justified, authorized and accepted by the client.
5.4.3. Methods for test including methods for sampling, are selected and used to
meet the needs of the client and are appropriate for the test undertaken.
Methods published as international, regional or other national standards are
used whenever possible. The latest valid edition of a standard is used unless
it is not appropriate or possible to do so. When necessary, the standards are
supplemented with additional details to ensure consistent application.
5.4.4. If the method to be used in not specified by the client, the laboratory
selects appropriate methods published either in international, regional, or
national standards or by reputable technical organizations or in relevant
scientific texts or journals or as specified by the manufacturer. Laboratory
developed methods or methods adopted by the laboratory may also be used
if they are appropriate for the intended use and if they are validated. The
client is informed as to the method chosen. The laboratory confirms that it
can properly operate standard methods before introducing the tests. If the
standard method changes, the confirmation is repeated.
5.4.5. The laboratory immediately notifies the client when the method proposed
by the client is considered to be inappropriate or out of date.
5.4.6. Introduction of laboratory-developed methods is a planned activity
assigned to qualified personnel equipped with adequate resources. Plans are
updated as development proceeds and effective communication amongst all
personnel involved is ensured.
5.4.7. When it is necessary to employ non-standardized methods, these are
subject to agreement with the client’s requirement and the purpose of the

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Botswana-Harvard HIV Document No.:
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Quality Manual
Tel: +267 3902671;
Fax: +267 3901284 Version : 1.0

test. The methods developed are validated appropriately before use and are
available for examination by the client and other authorized recipients. New
test methods are not used until written procedures have been developed.
5.4.8. All standard and non-standard test methods and procedures, including
those developed by the laboratory are validated to ensure that such methods
and procedures are fit for the intended use and are relevant to the
requirements of ISO/IEC 17025:2005 as well as the client. Validation is as
extensive as is necessary to meet the needs of the given application or field
of application. If changes are made to validated non-standard methods, the
influence of such changes is documented and if appropriate a new validation
is carried out. The results of such validation are recorded together with the
procedure utilized and any other relevant information. The record states
whether the method or procedure is fit for the intended use.
5.4.9. Validation is always a balance between costs, risks, and technical
possibilities and the range and accuracy of the values obtainable from
validated methods, as assessed for the intended use, is relevant to the client’s
needs.
5.4.10. Any calibrations performed in-house are subject to the SOP on Estimation
of Uncertainty of Measurement.
5.4.11. The SOP on Estimation of Uncertainty Measurement is applied for testing
uncertainness of measurement, except when the test methods prohibit such
rigorous calculations. In certain cases it is not possible to undertake
metrologically and statistically valid estimations of uncertainty of
measurement. In these cases the laboratory attempts to identify all
components of uncertainty and make the best possible estimation and ensure
that the form of reporting does not give an exaggerated impression of
accuracy. Reasonable estimation is based on knowledge of the performance
of the method and on the measurement scope and makes use of previous
experience and data. When estimating the uncertainty of measurement, all
uncertainty components which are of importance in the given situation shall
be taken into account using appropriate methods of analysis.
5.4.12. In cases where a well organized test method specifies limits to the values
of the major source of uncertainty of measurement and specifies the form of
presentation of calculated results, the laboratory is considered to have
satisfied the estimation of uncertainty of measurement by following the test
method and reporting instructions.
5.4.13. Calculations and data transfers are subject to appropriate checks in a
systematic manner. The accuracy of the calculations is verified, data
transfers are checked for typographical errors, omissions and mistakes.

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Botswana-Harvard HIV Document No.:
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Fax: +267 3901284 Version : 1.0

When computers or automated equipment are used for the acquisition,

processing, recording, storage, or retrieval of test data, BHHRL ensures
that:
5.4.14. Computer software developed by BHHRL is documented in sufficient
detail and suitably validated or otherwise checked as being adequate for use.
5.4.15. Procedures are established and implemented for protecting the integrity of
data; such procedures include but are not limited to, integrity and
confidentiality of data entry or collection, data storage, data transmission and
data processing.
5.4.16. Computers and automated equipment are maintained to ensure proper
functioning and are provided with the environmental and operating
conditions necessary to maintain the integrity of test and calibration data.
5.4.17. N.B. commercial software in general use within its designed application
range is considered to be sufficiently validated.
Refer to: Document No:
5.4.17.1. BHHRL/001PR018 Method and Equipment
Validation/Verification,
5.4.17.2. BHHRL/001PR017 Estimation of Uncertainty of Measurement,
5.4.17.3. BHHRL/001PR019 Control of Monitoring and Measuring
Devices,
5.4.17.4. BHHRL/001PR012 Records Control and Management.
5.4.17.5. Appendix 5 : List of Technical SOPs

5.5. Equipment
5.5.1. BHHRL is furnished with all the items of sampling, measurement and test
equipment required for the correct performance of the tests. In those cases
where BHHRL needs to use equipment outside its permanent control, it
ensures that the requirements of ISO/IEC 17025:2005 as well as those of
other regulatory authorities are met.
5.5.2. Equipment is operated by authorized personnel only. Up-to-date
instructions on the use and maintenance of equipment are readily available
for use by the appropriate laboratory personnel.
5.5.2.1.Refer to: Document No:
5.5.2.2.BHHRL/001PR020 Equipment and Instrument Management
5.5.2.3.BHHRL/001PR022 Measurement Traceability and Control of
Measuring Instruments.
5.5.2.4.BHHRL/001PR07 Control of Nonconforming work

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Botswana-Harvard HIV Document No.:
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Quality Manual
Tel: +267 3902671;
Fax: +267 3901284 Version : 1.0

5.6. Measurement Traceability

5.6.1. All equipment used for tests including equipment for subsidiary
measurements (e.g. for temperature monitoring) having a significant effect
on the accuracy or validity of the results of the tests, is calibrated before
being put into service. BHHRL maintains an SOP on Equipment and
Instrument Management and Control of Monitoring and Measuring Devices
to control maintain and calibrate its equipment.
5.6.2. The program of calibration of equipment is designed and operated so as to
ensure that calibrations and measurements made by the laboratory are
traceable to the international system of units by means of an unbroken chain
of calibrations or comparisons linking them to relevant primary standards of
the SI unit of measurement
5.6.3. Refer to: Document No:
5.6.3.1.BHHRL/001PR022 Measurement Traceability and Control of
Measuring Instruments.

5.7. Sampling
5.7.1. BHHRL maintains and utilizes a Laboratory Service Manual and an SOP
for Sample Collection for sampling when it carries out sampling of blood
and other samples for subsequent testing.
5.7.2. Both the Laboratory Services Manual and the SOP on Sample Collection
are available at all locations where sampling is undertaken. The sampling
process takes into consideration the factors to be controlled to ensure the
validity of the test results.
5.7.3. The sampling process, wherever reasonable, is based on appropriate
statistical techniques.
5.7.4. Where the client requires deviations, additions, or exclusions from the
documented sampling procedure, these are recorded in detail with the
appropriate sampling data and included in all documents containing test
results and communicated to the appropriate personnel.
5.7.5. BHHRL utilizes procedures for recording relevant data and operations
relating to sampling that forms part of the testing that is undertaken. These
records include the sampling procedure used, the identification of the
sampler, environmental conditions (if relevant) and equivalent means to
identify the sampling location as necessary and if appropriate the statistics
the sampling procedure is based upon.
5.7.6. Refer to: Document No:
5.7.6.1 BHHRL/002PR01 Laboratory Services Handbook

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Botswana-Harvard HIV Document No.:
Reference Laboratory BHHRL/001PL01
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Quality Manual
Tel: +267 3902671;
Fax: +267 3901284 Version : 1.0

5.7.6.2 BHHRL/002PR02 Specimen Management: Collection, Transportation

and Storage.

5.8. Handling and Transport of Samples

5.8.1. BHHRL maintains an SOP on Sample Management for the transport,
receipt, handling, protection, retention and disposal of samples, including all
provisions necessary to protect the integrity of the test samples and to protect
the interest of the laboratory and the client.
5.8.2. BHHRL also maintains the SOP for test sample identification. The
identification is retained through out the life of the item in the laboratory.
The system is designed and operated so as to ensure that samples cannot be
confused physically or when referred to in records or other documents. The
system, when appropriate, accommodates for the sub-division of groups of
samples and the transfer of the samples within and from the laboratory.
5.8.3. Upon receipt of the test samples, any abnormalities or departures from
normal or specified conditions as described in relevant test sample method
are recorded. When there is doubt as to the suitability of a sample, when an
item does not conform to the description provided, or when the test required
is not specified in sufficient details, the laboratory consults the client for
further instruction before proceeding and records the discussion.
5.8.4. BHHRL maintains procedures for and appropriate facilities for avoiding
deterioration, loss or damage to the test samples during storage, handling
and preparation; instructions provided with the samples are followed. When
samples have to be stored under specified environmental conditions, these
conditions are maintained, monitored and recorded. Where a sample or
portion of a sample is to be held secure (e.g. for reasons of record, safety, or
value, or to enable complementary tests to be performed later), the
laboratory makes arrangements for storage and security that protect the
condition and integrity of the secured samples or portions concerned.
5.8.5. Refer to: Document No:
5.8.5.1.BHHRL/002PR03 Specimen Management : Collection,
Transportation and Storage
5.8.5.2.BHHRL/002PR01 Laboratory Services Handbook

5.9. Assuring the Quality of Test Results

5.9.1. BHHRL maintains quality control procedures for monitoring the validity
of tests undertaken. This monitoring is planned and reviewed and may
include but not limited to the following:

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Fax: +267 3901284 Version : 1.0

5.9.1.1.1. Regular use of certified reference materials and internal quality

control using secondary reference materials.
5.9.1.1.2. Participation in inter laboratory comparison of proficiency
testing programs
5.9.1.1.3. Replicate tests using same different methods.
5.9.1.1.4. Re-testing of retained where applicable
5.9.1.1.5. Correlation of results for different characteristics of items.
5.9.1.1.6. Internal quality control schemes using statistical techniques.
5.9.2. Resulting data is recorded in such a way to detect trends and where
practicable, statistical techniques are applied to the reviewing of the results.
5.9.3. Refer to: Document No:
5.9.3.1.BHHRL/001PL02 Quality Assurance Program,

5.10. Reporting of Test Results

5.10.1. The results of each test or series of tests carried out by the laboratory are
reported accurately, clearly, unambiguously and objectively and in
accordance with any specific instructions in the test methods. The results are
normally reported in a test report and include all the information requested
by the client and necessary for the interpretation of the test results and all
information required by the method used.
5.10.2. In case the test is performed for internal clients, or in the case of a written
agreement with the client, the results may be reported in a simplified way
and may not require the formalized test report but all data is readily available
and kept permanently on file.
5.10.3. When opinions and interpretations are included in the test report, the basis
upon which the opinions and interpretations have been made is documented.
Opinions and interpretations are clearly marked as such in the test report. If
such opinions/interpretations are verbally communicated to the client, the
appropriate dialogue is recorded in writing. Opinions and interpretations
included in a test report may comprise, but not be limited to the following:
5.10.4. Opinion on the statement of compliance/non-compliance of the results
with requirements
5.10.4.1.1. Fulfilment of contractual requirements
5.10.4.1.2. Recommendations on how to use the results
5.10.4.1.3. Guidance on how to use the results.
5.10.5. When the test report contains reports of tests performed by subcontractors,
these results are clearly identified.
5.10.6. The format is designed to accommodate each type of test carried out and
to minimize the possibility of misunderstanding or misuse. Attention is

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given to the layout of the test report especially with regard to the
presentation of the test data and ease of assimilation by the reader.
5.10.7. Material amendments to a test report after issue are made only in the form
of a further document or data transfer, which includes the statement
“Supplement to Test Report…………” or an equivalent form of wording.
Such amendments meet all the requirements of ISO/IEC 17025:2005. When
it is necessary to issue a complete new report, it is uniquely identified and
contains a reference to the original that it replaces.
5.10.8. Refer to: Document No:
5.10.8.1. BHHRL/001PR025 Reporting of Laboratory Results,
5.10.8.2. BHHRL/001PR026 Handling of Laboratory Data.

6. Appendices
6.1. BHHRL Organogram
6.2. Table of Deputies
6.3. Quality Management Objectives
6.4. List of Technical SOP’s

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

Signed, Quality Manager : Date :

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 Project Director
APPENDIX 1 - BHHRL/001PR05 Dr Joseph Makhema
BHHRL Organogram
Lab Director
Quality Assurance Unit Dr Rosemary Musonda
Early Manyiwa – Deputy QAM Quality Assurance Manager
Tuelo Baitseng Munyaradzi Phibeon Research Lab
Zachariah Matshediso Mangwendeza *2 coordinator
Philimon
*2 Sebogodi Keikantse Matlhagela
(Safety Officer) Lab Manager
Mr Sikhulile Moyo Research Lab Team
Ulrik Fried (Post Doc/Research Fellow)
Thabo Diphoko (Forgarty Fellow)
Ching Na Rim (Forgarty Fellow)
Raabya Rossenkan (PhD Student)
Specimen Management Supplies/Lab Admin
Ms Busisiwe Mlotshwa Kutlwano Aupiti
Taboka Moloi

1
PBMC Lab*
Specimen Reception Specimen Inventory Lemme Kebaabetswe Shipping
Kedibonye Rammidi Susan Kobe Lebogang Mhango Tuelo Baitseng
Kgakgamatso Motswana Motshepe Motswedi Anderson Philimon Sebogodi
Keothepile Nthebogang Phiri Thato Iketleng
Angela Nkhutelang
Sethunya Ledikwe

Chemistry Lab Serology Lab Hematology Lab CD4 Lab DNA PCR Lab Viral Load Lab
Baitshepi Jorowe Victoria Maiswe Matshediso Talkmore Maruta Dorcus Moses Phillimon Sebogodi
Dineo Mongwato Zachariah Gaone Retshabile Terrence M.

BHP Protocol Specific Allocations

Dikotlana (BHP011) Tshedimoso (BHP012) Tshepo (BHP007) MmaBana (BHP016) Mashi_Plus Mashi (BHP004)
Victoria Maiswe Lemme Kebaabetswe Models of Care Phillimon Sebogodi (BHP019)
Baitshepi Jorowe Dorcus Moses

Botsogo (BHP010) CTU (ACTG/IMPAACT) BHP017/BHP023 Basadi (BHP018) Host Genetics Bana-Baylor
Models of Care Lebogang Mhango (BHP022) Talkmore Maruta
Kgalalelo Johane Motswedi Anderson Chabeni Zimba
Gaone Retshabile Kebaneilwe Lebani

*1 Assigned scheduled event

*2 Policy, regulatory and Global Issues (routine activities reported to the Lab Manager)

Approved by: Dr. Rosemary Musonda Title: Laboratory Director Sign:……………………………………………………………. Date:…………………………………….
 APPENDIX 2 – QUALITY MANUAL

BHHRL Table of Deputies

The policy of BHHRL is such that a top management member will ‘ACT’ in place of the
absent manager/director. The name of the acting manager/director is circulated to staff if
and when the need arises.

Post Incumbent Deputizing

Project Director Dr. Joe Makhema On acting capacity
Lab Director Dr. Rosemary On acting capacity
Musonda
Lab Manager Mr. Sikhulile Moyo On acting capacity
Quality Manager Mr. Phibeon Ms. Early Manyiwa
Mangwendeza
Research Lab Coordinator Dr. Keikantse *appointed when needed
Matlhagela
Specimen Management Ms Busisiwe *appointed when needed
Supervisor Mlotshwa

Approved by: Dr. Rosemary Musonda, Laboratory Director

Signed:…………………………..

Date: …………………………..
 APPENDIX 3 – QUALITY MANUAL

BHHRL Quality Management Objectives

1. Achieve laboratory accreditation by December 2009

2. Achieve certification of relevant and critical laboratory sections
3. Meet customer expectations for on-time delivery of results.
4. Avoid waste and excessive cost of running tests without jeopardizing quality of
results obtained.
5. Provide a safe and healthy working environment for all employees.
6. Obtain fewer customer quality concerns
7. Pass internal and external audits
8. Maintain EQA performance above 80%

Approved By: Dr. Rosemary Musonda, Laboratory Director

Sign: …………………………………..

Date: …………………………………
 APPENDIX 4 – Quality Manual
Document
Document title
number
002/WIN-01 Daily Specimen Reception and Processing
002/WIN-02 Specimen Rejection Creteria
002/EQI-01 Beckman Allegra 21 Centrifuge Operating Instruction
007/TME-02 Amplicor HIV-1 DNA test
007/TME-01 QIAmp DNA Blood kit
001/PRC-03 Transporting of Specimens Within the Laboratory
001/PRC-05 Sample Storage
003/EQI-01 Becton Dickinson FACS Calibur Flow Cytometer Operating Instructions
003/WIN-03 Running TRUCOUNT Controls
003/WIN-04 Ensuring FACSCount Pipetting Precision and Accuracy
003/WIN-06 Validating CD4 results using LDMS
005/TME-01 Whole Blood Analysis (Full Blood Count) Using XE-2100 Haematology Analyser-
003/WIN-05 Work Listing Samples For CD4 Testing Using Laboratory Management
Information Systems (LMIS)
003/TME-02 Enumeration of absolute counts of CD4, CD8 and CD3 T lymphocytes in unlysed
whole blood using BD FACSCount System
003/WIN-07 FACSCOMP
003/EQI-02 Operating Instructions for Becton Dickinson's FACSCount System
003/TME-03 Automated Staining for flow cytometry lyse/no-wash applications using BD
Sample Processor (SP-1)
001/PRC-04 Validation of Equipment, Testing Methods, Materials and Processing -Standard
Operating Procedures
004/EQI-02 COBAS AMPLICOR Analyzer
004/EQI- 01 Equipment Operating Instructions for COBAS Ampliprep Analyser
004/TME- 02 COBAS Ampliprep AMPLICOR HIV-1 Monitor Test, version 1.5
004/TME-01 COBAS Ampliprep/COBAS Monitor Test, version 1.5
008/TME-06 Urine Microscopy
008/TME-05 Urinalysis - COMBUR 10 Test
003/TME-01 Enumeration of Leucocyte Subsets Using FACS Calibur Flow Cytometer
008/TME-03 Quantitaive Determination Of Clinical Chemistry Analytes In Plasma And Serum
Using COBAS Integra 400 Plus
008/EQI-01 COBAS Integra 400 Plus
008/TME-04 Reporting Critical Chemistry and Haematology Results
006/TME-01 Manual HIV ORTHO Antibody-Capture Test
006/TME-02 Manual Method for MUREX HIV -1.2.0
006/TME-03 Enzyme Immunoassay for the Detection of Hepatitis B Surface Antigen in Human
Serum or Plasma- Murex HBsAg Version 3.
006/TME-04 An Enzyme immunoassay for the detection of antibodies to Hepatitis C virus
(HCV) in human serum or plasma. Murex anti-HCV (Version 4.0)
006/TME-06 Qualitative Determination Of Human Chorionic Gonadotrophin (hCG) In Urine For
Early Detection Of Pregnancy- ABBOTT TestPack Plus hCG COMBO with OBC
006/WI-05 Vironostika Less Sensitive EIA
 APPENDIX 4 – Quality Manual
Document
Document title
number
006/WI-04 An enzyme immunoassay for the detection of antibodies to hepatitis C virus (HCV)
in human serum or plasma. Murex anti-HCV (Version 4.0)
006/WI-03 Enzyme Immunoassay for the Detection of Hepatitis B Surface Antigen in Human
Serum or Plasma- Murex HBsAg Version 3.0
006/WI-01 HIV ORTHO ANTIBODY- CAPTURE TEST
006/WI-02 MANUAL ELISA METHOD FOR MUREX HIV 1.2.0- WORK INSTRUCTION
004/WI-01 Manual RNA Extraction (COBAS AMPLICOR HIV-1 Monitor Test, Version 1.5
Standard) HIM
004/WI-02 Preparing Working Master Mix (COBAS AMPLICOR HIV-1 Monitor Test, Version
1.5 Standard) HIM & PHM
004/WI-03 Loading A- Rings (COBAS AMPLICOR HIV-1 Monitor Test, Version 1.5 Standard)
HIM & PHM
002/EQI-02 Multifuge 3L Heraeus Centrifuge Operating Instructions
002/WIN-04 Standard Operating Procedure for Specimen Collection, Transport and Results
handling for the Botswana Vaccine Trail Units in Gaborone and Jwaneng for HIV
Vaccine Trial Network Protocol 903
002/WIN-03 Specimen Collection, Transport and Results handling for the Botswana Vaccine
Trail Units for HIV Vaccine Trial Network Protocol 048
009/EQI-01 GUAVA PCA CELL COUNTER
009/TME-01 Isolation of Peripheral Blood Mononuclear Cells (PBMCs)
007/TME- 03 HLA TYPING
001/PRC-22 Bi-Distiller Operating instructions
008/EQI-02 Roche Integra Cassette Mixer Operating Instructions
008/WI-01 Urinalysis COMBUR 10 Test
006/EQI-01 Welcome Shaker
006/TME-05 Syphilis Rapid Plasma Reagin (RPR) Test- Qualitative
006/TME-07 Haemagglutination kit for the detection of antibodies to Treponema pallidum in
human serum- Wellcosyph HA*
001/PRC-16 Autoclave Operating Instructions
002/WIN-05 HVTN 048 Specimen Reception
002/WIN-07 Laboratory Data Management System (LDMS)
002/WIN-08 Shipping Diagnostic Specimen
002/WIN-09 Capturing the Tracking Form Information Using Laboratory Management
Information Systems (LMIS)
002/WIN-11 Receiving Specimens into Laboratory Management Information Systems (LMIS)
002/WI-07 HVTN Sample Reception
002/WI-08 Creating LDMS labels using Zebra Printer
002/WI-09 HVTN 048 LDMS Logging and labeling guide
009/WI-01 PBMC Specimen Processing
009/EQI-02 Biofuge Primo Centrifuge /Operation Instruction
009/EQI-03 Water Bath Operating Instructions
009/EQI-04 Multifuge 3 s-r Centrifuge Operation Instruction
 APPENDIX 4 – Quality Manual
Document
Document title
number
006/WI-08 BEHRING ELISA PROCESSOR (BEP2000) OPERATING INSTRUCTIONS
006/WI-06 Bio-Tek ELX50 Automated Strip Washer Operation Instructions
006/WI-07 Bio-Tek ELX800 Universal Plate Reader Operation Instructions
007/EQI-03 Operation of the GILSON Pipetman
007/WI-01 DNA EXTRACTION-QIAGEN KIT
007/WI-02 DNA EXTRACTION- SPECIMEN PREPARATION
007/WI-03 DNA EXTRACTION- REAGENT PREPARATION
007/WI-04 Operation of the GRANT QBT2 Block Incubator
007/WI-05 Maxi-Mix Vortex Mixer Operation Instructions
007/WI-06 DNA Detection
007/WI-07 IEC Micromax Microfuge
007/WI-08 DNA Amplification
007/WI-09 Ultra Violet (Hood)- Captair bio by erlab Operation Instruction
007/WI-10 ABI PRISM 3100 Genetic Analyzer Operation Manual
007/WI-11 GeneAmp PCR System 9700
004/WI-04 Loading Specimens and controls for Ampliprep
009/WI-02 Starting the GUAVA PCA Cell counter
003/TME-04 Double- Platform (Dual) Enumeration CD4+ T-Cells By Flow Cytometry
002/WIN-06 HVTN Specimen Rejection Criteria
001/PRC-21 Transporting Of Specimens From Site To Laboratory
002/WIN-12 HVTN 903 Specimen Reception Standard Operating Procedures
002/WI-10 HVTN 903 LDMS Logging and labeling guide
002/WIN-13 Reporting Syphilis Titer Results
002/WIN-14 Reporting Results From the Clinic to BHHRL