Quality Policy Manual for Medical Laboratory Services in Kenya / 

ii / Quality Policy Manual for Medical Laboratory Services in Kenya

 Quality Policy Manual
for
Medical Laboratory Services in Kenya

Quality Policy Manual for Medical Laboratory Services in Kenya / iii

Ministry of Medical Services
PO Box 30016, Nairobi, Kenya
Tel: +254 20 2717077
Fax +254 20 2713234
and
Ministry of Public Health and Sanitation
PO Box 30016, Nairobi, Kenya
Tel: +254 20 2717077
Fax +254 20 2713234

2011, Ministry of Medical Services and Ministry of Public Health and Sanitation, Kenya

Published by the Ministry of Medical Services and the Ministry of Public Health and Sanitation,
Kenya, with the support of the African Medical and Research Foundation (AMREF).

ISBN: 978-9966-874-xx-x
The authors and publishers will gladly consider any request for permission to reproduce part
or the whole of this manual with the intention of increasing its availability to those who need
it. The Ministry of Medical Services and Ministry of Public Health and Sanitation, Kenya,
welcome enquiries from individuals or organizations wishing to use any material from this
publication for non-commercial purposes.

Editing, design and layout by Dali Mwagore

Printing by xxx

iv / Quality Policy Manual for Medical Laboratory Services in Kenya

Contents

ACKNOWLEDGEMENTS........................................................................................................... 9
FOREWORD ................................................................................................................................. 10
PREFACE ...................................................................................................................................... 12
ABBREVIATIONS......................................................................................................................... 13
DEFINITION OF TERMS............................................................................................................. 14
CHAPTER 1: MEDICAL LABORATORY SERVICES OF KENYA......................................... 17
1.1 Background to Medical Laboratory Services of Kenya..................................................... 17
1.2 National organizational structure of the medical laboratory services............................ 18
1.2.1 Organization of the medical laboratory services...................................................... 18
1.2.2 Quality Assurance Office.............................................................................................. 18
1.2.3 Activities of medical laboratories . ............................................................................. 20
1.3 Levels of laboratory services................................................................................................. 21
1.3.1 Levels 1 and 2dispensary and health centre laboratories.................................... 21
1.3.2 Levels 3 and 4district and provincial hospital laboratories................................ 21
1.3.3 Level 5reference and specialized laboratories....................................................... 21
Contacts.................................................................................................................................... 22
CHAPTER 2: LABORATORY QUALITY POLICY, STRATEGY AND GOALS.................... 23
2.1 Quality policy.......................................................................................................................... 23
2.2 Quality statement................................................................................................................... 23
2.3 Quality goal.............................................................................................................................. 23
2.4 Vision, mission and value statements of the medical laboratory services..................... 23
2.4.1 Vision............................................................................................................................... 23
2.4.2 Mission............................................................................................................................ 23
2.5 Scope and purpose of the Quality Policy Manual for Medical ...........................................
Laboratories in Kenya .............................................................................................................. 24
2.5.1 Scope of the Quality Policy Manual.............................................................................. 24
2.5.2 Purpose of the Quality Policy Manual.......................................................................... 24
2.6 Structure of the Quality Policy Manual.................................................................................. 25
Background information....................................................................................................... 21
CHAPTER 3: LABORATORY ORGANIZATION AND MANAGEMENT.......................... 26
3.1 Purpose..................................................................................................................................... 26
3.2 Policy ...................................................................................................................................... 26
3.3 Responsibilities........................................................................................................................ 27
3.3.1 Laboratory manager/director..................................................................................... 27
3.3.2 Laboratory quality manager........................................................................................ 27

Quality Policy Manual for Medical Laboratory Services in Kenya / 

 3.3.3 Laboratory technical staff............................................................................................. 28
3.3.4 Laboratory support staff............................................................................................... 28
3.4 Laboratory organizational structure at facility level......................................................... 28
3.5 Quality management systems.............................................................................................. 28
3.5.1 Management review...................................................................................................... 28
Background information....................................................................................................... 29
CHAPTER 4: PERSONNEL......................................................................................................... 30
4.1 Purpose.................................................................................................................................... 30
4.2 Policy ...................................................................................................................................... 30
4.3 Responsibilities....................................................................................................................... 30
4.3.1 Laboratory manager/director..................................................................................... 30
4.3.2 Quality manager............................................................................................................ 30
4.3.3 Laboratory technical staff............................................................................................. 31
4.4 Procedures and processes...................................................................................................... 31
4.4.1 Staff recruitment, orientation and induction............................................................. 31
4.4.2 Competency assessment............................................................................................... 31
4.4.3 Training and education................................................................................................. 32
4.4.4 Personnel records.......................................................................................................... 33
4.4.5 Job descriptions.............................................................................................................. 34
4.4.6 Employee performance appraisal............................................................................... 34
Background information....................................................................................................... 34
CHAPTER 5: WORK AREA HEALTH AND SAFETY MANAGEMENT............................. 36
5.1 Purpose.................................................................................................................................... 36
5.2 Policy ...................................................................................................................................... 36
5.3 Responsibilities....................................................................................................................... 36
5.4 Procedures................................................................................................................................ 36
5.4.1 Reporting emergencies................................................................................................. 37
5.4.2 Fire emergencies............................................................................................................ 37
5.4.3 First aid........................................................................................................................... 37
5.4.4 Personal protective equipment.................................................................................... 37
5.4.5 No smoking or eating in the laboratory..................................................................... 38
5.4.6 Universal safety precautions........................................................................................ 38
5.4.7 Laboratory security....................................................................................................... 38
Background information....................................................................................................... 39
CHAPTER 6: LABORATORY EQUIPMENT MANAGEMENT..................................... 40
6.1 Purpose.................................................................................................................................... 40
6.2 Policy ...................................................................................................................................... 40
6.3 Responsibilities....................................................................................................................... 40

vi / Quality Policy Manual for Medical Laboratory Services in Kenya

 6.3.1 Laboratory manager/director..................................................................................... 41
6.3.2 Quality manager............................................................................................................ 41
6.3.3 Laboratory technical staff............................................................................................. 40
6.4 Procedures and processes...................................................................................................... 41
6.4.1 Selection of laboratory equipment.............................................................................. 41
6.4.2 Equipment validation and commissioning................................................................ 42
6.4.3 Equipment maintenance programme......................................................................... 42
6.4.4 Inventory management................................................................................................ 43
6.4.5 Equipment documents and records............................................................................ 43
Background information....................................................................................................... 44
CHAPTER 7: LABORATORY SUPPLIES MANAGEMENT................................................... 45
7.1 Purpose.................................................................................................................................... 45
7.2 Policy ...................................................................................................................................... 45
7.3 Responsibilities....................................................................................................................... 45
7.3.1 Laboratory manager/director..................................................................................... 45
7.3.2 Quality manager............................................................................................................ 45
7.3.3 Laboratory technical staff............................................................................................. 45
7.4 Procedures and processes...................................................................................................... 46
7.4.1 Commodity flow............................................................................................................ 46
7.4.2 Ordering laboratory commodities.............................................................................. 47
7.4.3 Considerations for ordering supplies......................................................................... 47
7.4.4 Storage and stock control............................................................................................. 47
7.4.5 Stock records in inventory management.................................................................... 47
CHAPTER 8: SPECIMEN COLLECTION, PROCESSING AND REPORTING................... 49
8.1 Purpose.................................................................................................................................... 49
8.2 Policy ...................................................................................................................................... 49
8.3 Procedures............................................................................................................................... 49
8.3.1 Pre-analytical procedures............................................................................................. 49
8.3.2 Analytical procedures................................................................................................... 52
8.3.3 Post-analytical procedures........................................................................................... 52
Background information....................................................................................................... 54
CHAPTER 9: QUALITY ASSURANCE IN THE MEDICAL LABORATORY...................... 55
9.1 Purpose.................................................................................................................................... 55
9.2 Policy ...................................................................................................................................... 55
9.3 Responsibilities....................................................................................................................... 55
9.3.1 Laboratory manager/director..................................................................................... 55
9.3.2 Quality manager............................................................................................................ 55
9.3.3 Laboratory technical staff............................................................................................. 55

Quality Policy Manual for Medical Laboratory Services in Kenya / vii

9.4 Quality assurance indicators................................................................................................. 56
9.5 Reagent storage and calibration............................................................................................ 56
9.6 Internal quality control........................................................................................................... 56
9.7 External quality assessment.................................................................................................. 57
9.8 Laboratory assessment........................................................................................................... 57
9.8.1 Laboratory audits.......................................................................................................... 57
9.9 Occurrence management....................................................................................................... 58
Background information....................................................................................................... 59
CHAPTER 10: DOCUMENTATION AND TECHNICAL RECORDS MANAGEMENT... 60
10.1 Purpose................................................................................................................................... 60
10.2 Policy ...................................................................................................................................... 60
10.3 Responsibilities...................................................................................................................... 60
10.3.1 Laboratory director/ manager................................................................................ 60
10.3.2 Quality manager........................................................................................................ 60
10.3.3 Laboratory technical staff......................................................................................... 60
10.4 Procedures and processes.................................................................................................... 61
10.4.1 Quality documents and technical records............................................................. 61
10.4.2 Controlling laboratory quality documents............................................................ 62
10.4.3 Long-term maintenance and retention of laboratory documents and
records...................................................................................................................................... 62
Bibliography............................................................................................................................ 63
CHAPTER 11: LABORATORY INFORMATION MANAGEMENT SYSTEM..................... 64
11.1 Purpose................................................................................................................................... 64
11.2 Policy ...................................................................................................................................... 64
11.3 Responsibilities...................................................................................................................... 64
11.3.1 Laboratory manager/director................................................................................. 64
11.3.2 Quality manager........................................................................................................ 64
11.3.3 Laboratory technical staff......................................................................................... 64
11.3.4 IT personnel................................................................................................................ 65
11.4 Procedure and processes...................................................................................................... 65
11.4.1 Use of LIMS................................................................................................................ 65
11.4.2 Data collection tools.................................................................................................. 65
11.4.3 Laboratory information management.................................................................... 65
Background information....................................................................................................... 66
CHAPTER 12: LABORATORY COMMUNICATION MANAGEMENT.............................. 67
12.1 Purpose................................................................................................................................... 67
12.2 Policy ...................................................................................................................................... 67
12.3 Responsibilities...................................................................................................................... 67

viii / Quality Policy Manual for Medical Laboratory Services in Kenya

12.4 Procedure and processes...................................................................................................... 67
12.4.1 Classification of laboratory communication............................................................ 67
12.4.2 Interactions with other professionals....................................................................... 68
12.4.2 Interaction with patients............................................................................................. 68
12.4.2 Interaction with suppliers.......................................................................................... 69
Background information....................................................................................................... 69
APPENDIX 1: DOCUMENT RETENTION GUIDELINES ................................................... 71
Appendix 2: Documents Review and Authorisation Signatures........... 74
appendix 3: documents training records........................................................... 75
APPENDIX 4: CONTRIBUTORS AND REVIEWERS . .......................................................... 76

Quality Policy Manual for Medical Laboratory Services in Kenya / ix

 / Quality Policy Manual for Medical Laboratory Services in Kenya
ACKNOWLEDGEMENTS

This Quality Policy Manual for Medical Laboratory Services in Kenya was developed by the
Ministry of Medical Services and Ministry of Public Health and Sanitation, Kenya, and
partners. Technical support was provided by the Quality Systems Subcommittee of the
Laboratory Interagency Coordinating Committee (ICC). The ministries of Medical Services
and Public Health and Sanitation, Kenya, would like to acknowledge the generous support
of the United States Agency for International Development (USAID) and the Management
Sciences for Health, Strengthening Pharmaceutical Systems (MSH/SPS) project for
financially supporting the development of this Quality Policy Manual and to the Centers for
Disease Control and Prevention (CDC), Kenya, and Laboratory Programme of the African
Medical and Research Foundation (AMREF) for finalising and printing the Manual.
Many people have read this manual during its development and made valuable suggestions
most of which have been incorporated in the text. We would like to take this opportunity
to thank all those who participated in the development, review and editing of this Manual
for their contributions.
Special thanks go to the following technical working group members who participated
in the development of the first draft of the Quality Policy Manual and provided valuable
contributions towards its completion:
John Matoke National Public Health Laboratory Services
Peter Lokamar Ministry of Medical Services
Angela Amayo Management Sciences for Health
David Isaboke African Medical and Research Foundation
Ernest Makokha Centers for Disease Control and Prevention
Jedida Wachira Management Sciences for Health
Julius Tome African Medical and Research Foundation
Kevin Omondi Risk Accredit Management Systems
Martin Matu African Medical and Research Foundation
Rodgers Dena African Medical and Research Foundation
Enock Marita African Medical and Research Foundation
Samwel Mbugua Management Sciences for Health
Tura Galgalo Centers for Disease Control and Prevention
Valentine Magero Family Health International

Members of the editorial team were:

Jane Carter African Medical and Research Foundation, Headquarters
Isaac Mugo African Medical and Research Foundation in Kenya
Martin Matu African Medical and Research Foundation in Kenya
Julius Tome African Medical and Research Foundation in Kenya
Ernest Makokha Centers for Disease Control and Prevention, Kenya

Quality Policy Manual for Medical Laboratory Services in Kenya / xi

Jane Mwangi Centers for Disease Control and Prevention, Kenya
Angela Amayo Management Sciences for Health
Moses Njue Department of Diagnostics and Forensic Services
We would like to acknowledge all the contributors and reviewers listed in Appendix 4 of
this Manual for their valuable inputs and suggestions.

xii / Quality Policy Manual for Medical Laboratory Services in Kenya

FOREWORD

It is now acknowledged that clinical and public health laboratories are the gateway to
effective disease prevention, control and patient management. This realization has led
to a heightened focus on strengthening and mainstreaming quality laboratory systems
within national health systems. The purpose of the laboratory within a health system is
to provide information that is critical for evidence-based decision making to guide health
care interventions.
The Kenya National AIDS Strategic Plan (KNASP) III (20092013) recommends improving
integrated quality assurance and management systems in public and non-public health
facilities. The National Health Sector Strategic Plan (NHSSP) II (20052010) also recommends
registration, inspection and control of public and private health care providers as some of
the efforts for improving quality assurance and standards.
Quality laboratory services in Kenya have been hampered by weak organizational
structures, inadequate regulation, deficiency in staffing, inadequate physical infrastructure,
undefined policy for laboratory equipment care and maintenance, erratic commodity
supply, and lack of efficient laboratory documentation, monitoring and evaluation systems.
In the recent past, HIV and AIDS prevention and care programmes have placed special
demands on health laboratories. However, these programmatic demands have provided
impetus for improving the quality of laboratory services country-wide.
The Government of Kenya is committed to enhancing quality health care in all medical
laboratories. The development of this Quality Policy Manual for Medical Laboratories in
Kenya is timely and stems from a well-founded background. In its first edition, this twelve-
chapter Manual clearly defines the laboratory Quality System Essentials and documents the
policies and procedures needed to implement continuous laboratory service improvements
towards meeting international accreditation standards, such as ISO 15189.
This Manual will be an invaluable source of information and guidance to both laboratory
and non-laboratory staff in improving quality of laboratory services through evidence-
based practices. This Manual will also act as a quick reference for both laboratory and
clinical staff in striving to meet the stringent ISO accreditation standards.

Dr S K Sharif Dr Francis M Kimani

Director, Public Health and Sanitation Director of Medical Services
Ministry of Public Health and Sanitation Ministry of Medical Services

Quality Policy Manual for Medical Laboratory Services in Kenya / xiii

PREFACE

This Quality Policy Manual for Medical Laboratories in Kenya establishes overall policies
for the national quality management system for medical laboratory services in Kenya.
These policies have been developed in line with the international quality management
system standardsISO 15189 or equivalentof the International Organization for
Standardization (ISO), IEC 17025:2005, general requirements for competence in testing and
calibrating laboratories, and the Clinical Laboratory Standards Institute based on twelve
quality system essentials, the Maputo Declaration of 2008 and the National Policy Guidelines for
the Medical Laboratory Services of Kenya (2006).
The National Policy Guidelines are aligned with the national strategic plans of the Ministry
of Medical Services and the Ministry of Public Health and Sanitation. Both ministries have
established a number of programmes that address disease control and strengthen specific
disease-targeted laboratory services through the Division of Leprosy, Tuberculosis and
Lung Disease, the National AIDS and STI Control Programme, and the Division of Malaria
Control. In addition, a health services accreditation plan has recently been introduced
to improve overall hospital quality assurance systems. Laboratories will specifically be
accredited to the ISO 15189 or equivalent standard. Accreditation will provide objective
documentation that each laboratory has the capacity to accurately detect, identify, and
promptly report diseases of clinical and public health significance.
This Manual defines the scope of the national quality management system (QMS). It
documents the processes needed to implement the QMS and achieve quality laboratory
services. It contains policy statements on the vision, mission and quality objectives. These
policy statements are intended to ensure the understanding and effective planning,
operation and control of key QMS processes in all laboratories. Besides organizational
management requirements, this Manual describes the technical requirements for quality
laboratory procedures before, during and after test procedures. These requirements include
sampling, work area control, equipment management, document control, biosafety, quality
assurance, laboratory information management and client satisfaction.

Dr Willis Akhwale Dr Moses Njue

Head, Department of Diseases Head, Department of Diagnostics and Forensic
Prevention and Control Services/National Blood Transfusion Services
Ministry of Public Health & Sanitation Ministry of Medical Services

xiv / Quality Policy Manual for Medical Laboratory Services in Kenya

ABBREVIATIONS

AIDS acquired immunodeficiency syndrome

CDC Centers for Disease Control and Prevention
CLSI Clinical Laboratory Standards Institute
DLTLD Division of Leprosy, Tuberculosis and Lung Disease
DMLT district medical laboratory technologist
DOMC Division of Malaria Control
EQA external quality assessment
HIV human immunodeficiency virus
HMT health management team
ICT information communication technology
IQC internal quality control
IP inpatient
ISO International Standardization Organization
LIMS Laboratory Information Management System
LLMIS Laboratory Logistics Management Information System
MLS Medical Laboratory Services of Kenya
MOH Ministry of Health
NASCOP National AIDS and STI Control Programme
NBTS National Blood Transfusion Services
NPHLS National Public Health Laboratory Services
OP outpatient
PMLT provincial medical laboratory technologist
PPE personal protective equipment
QA quality assurance
QM quality manager
QMS quality management system
QSE quality system essentials
SOP standard operating procedure
STAT shortest turn-around time
STI sexually transmitted infection
TAT turn-around time
TB tuberculosis
WHO World Health Organization

Quality Policy Manual for Medical Laboratory Services in Kenya / xv

DEFINITION OF TERMS

Accreditation process by which an authoritative body gives formal

recognition that a body or person is competent to carry out
specific tasks
Analytical sensitivity ability of a test to give correct results for a specific analyte
Audit systematic, independent and documented process for
obtaining and evaluating objective data to determine the
extent to which set criteria are fulfilled
Client person or organization using the medical laboratory services
Complaint user dissatisfaction or opinion addressing an area in which
the service provided has failed to meet their requirements
Corrective action steps taken to eliminate the cause of a detected non-conformity
or other undesirable situation. Note: Corrective action is taken
to prevent recurrence of a non-conformity whereas preventive
action is taken to prevent occurrence of a non-conformity
Document control a system of managing records that allows storage, search and
retrieval through using keywords, attributes, titles and codes
Linearity a straight line describing the relationship between the method
and the analyte being investigated
Non-conformity non-fulfilment of a requirement in a specific standard
Organizational arrangement of responsibilities, authorities and relationships
structure between offices and personnel in an organization
Post-analytical phase all the steps following the examination of a specimen including
systematic review, interpretation, authorization for release,
reporting and transmission of results, and storage of samples
and data
Pre-analytical phase all the steps starting from the clinicians request, including
(pre-examination examination requisition, preparation of the patient, collection
process) of the primary sample, transportation of the specimen to
and within the laboratory, and ending when the specimen
examination procedure starts
Premises physical environment in which an organisation carries out
particular functions
Preventive action action to eliminate potential non-conformities or other
undesirable potential situations. Note: Preventive action is
taken to prevent occurrence of a non-conformity whereas
corrective action is taken to prevent recurrence

xvi / Quality Policy Manual for Medical Laboratory Services in Kenya

Procedure specified, systematic actions to carry out an activity or process.
Note: When the term procedure is used in this document a
written procedure is required that is subject to standardisation,
document control, regular review and revision
Quality assurance a planned and systematic pattern of all actions necessary
to provide adequate confidence that the product/services
optimally fulfils customers expectations.
Quality control quality control is a procedure or set of procedures intended
to ensure that a product or performed service adheres to a
defined set of quality criteria.
Quality improvement part of quality management focused on continually increasing
accuracy, effectiveness and efficiency. Note: the term continual
quality improvement is used when quality improvement is
progressive and the organization actively seeks and pursues
improvement opportunities
Quality management management system to direct and control an organization
system with regard to quality services
Quality objective something sought, or aimed for, relating to quality. Note:
Quality objectives are generally based on an organizations
quality policy
Quality planning part of quality management focusing on setting quality
objectives and specifying necessary operational processes and
resources required to fulfil quality objectives
Quality policy document specifying the quality management system of an
organization that includes overall intentions and direction of an
organization related to the fulfilment of quality requirements
as specified by management. Note: The quality policy shall
be consistent with the overall policy of the organization and
shall provide a framework for setting quality objectives
Referral laboratory external facility to which a sample is submitted for
supplementary or confirmatory examination procedure and
report
Requirement need or expectation that is stated, generally implied or
obligatory
Review activity undertaken to ensure the suitability, adequacy,
effectiveness and efficiency of the subject matter to achieve
established objectives
Sensitivity percentage of true positive laboratory results that are correctly
identified

Quality Policy Manual for Medical Laboratory Services in Kenya / xvii

Specificity percentage of true negative laboratory results that are correctly
identified
Validation confirmation, through the provision of objective evidence,
that the requirements for a specific intended use or application
have been fulfilled
Work environment set of conditions under which work is performed

xviii / Quality Policy Manual for Medical Laboratory Services in Kenya

CHAPTER 1: MEDICAL LABORATORY SERVICES OF KENYA

1.1 Background to Medical Laboratory Services of Kenya

The value of the medical laboratory in supporting diagnosis and patient management
cannot be underestimated. The national medical laboratory services, as part of the national
health system, support the following health service components:
curative
preventive
health promotion
surveillance
research and training
The strategic thrust in delivering medical services in Kenya is to institute medical service
reforms that will ensure availability of quality services. Currently, the hospital reform
agenda in Kenya aims to ensure high quality and appropriate medical services, with
improved management efficiency and delivery of medical services at health facilities
focusing on three key areas:
1 Improving the quality of health care provided through:
improving the skills of middle-level managers in leadership and management
improving the skills of all technical staff working in health services
instituting mechanisms for regularly monitoring health facility performance
re-invigorating specimen and patient referral systems
applying information communication technology in providing and managing
information and services in all level 46 facilities
2 Reforming the oversight provided to health facilities in terms of:
strengthening governance and accountability systems in health facilities
putting in place a health service commission
instituting health facility autonomy measures
introducing innovation in providing health services to ensure services keep
abreast with new technological developments
3 Instituting and enforcing appropriate regulatory measures for medical services by:
guiding provision of health services in general and medical services in particular
harmonizing the link between the ministries roles and functions and the respective
professional bodies
strengthening the regulatory framework and roles and responsibilities of boards
and councils in line with current expectations
ensuring professional bodies contribute to professionalism and ethics, and to
enforcement of standards and regulations
The reform agenda will encompass all health sectors including medical laboratories.
The Standards, Research and Regulation Department of the Ministry of Health is taking

Quality Policy Manual for Medical Laboratory Services in Kenya / 

the lead since it is charged with setting policy and guidelines for strengthening quality
management in healthcare and enhancing the regulatory role of the government.

1.2 National organizational structure of the medical laboratory services

1.2.1 Organization of the medical laboratory services

Medical laboratory services cut across the two Ministries of Health Departments and
Divisions. The Ministry of Medical Services oversees health facilities at Level 4 and above
through the Division of Medical Laboratory Services under the Department of Diagnostic
and Forensic Services and reports through this department to the Director of Medical
Services. The Ministry of Public Health and Sanitation is responsible for health facilities
at Level 3 and below through the National Public Health Laboratory Services under the
Department of Disease Prevention and Control whose head reports to the Director of
Public Health and Sanitation. The national Quality Assurance Office oversees all quality
issues within all the medical laboratories in the country including the national public
health reference laboratories, and laboratories at provincial and district hospitals, health
centres and dispensaries.

1.2.2 Quality Assurance Office

The national Quality Assurance Office is headed by a Quality Assurance Officer who reports
to the Chief Medical Laboratory Technologist. The Quality Assurance Office is responsible
for coordinating all quality assurance activities in the country. The office shall:
coordinate external quality assessment (EQA) activities including:
o conducting baseline surveys of laboratory services
o preparing EQA panels
o distributing EQA materials to facilities
o reviewing EQA reports and providing feedback to the facilities
provide supportive supervision to address issues raised by performance in EQA
activities
develop, disseminate and review laboratory standards such as quality assurance
policy guidelines and standard operating procedures
mobilize and budget for resources to support quality assurance activities
ensure all laboratories participate in appropriate EQA schemes
The organization and management of medical laboratories in Kenya is shown in the
following organograms.

 / Quality Policy Manual for Medical Laboratory Services in Kenya

 Minister for Public Health
and Sanitation

Permanent Secretary

Director of Public Health

and Sanitation

Head, Department of Disease

Prevention and Control
(DDPC)

Division of Malaria Control

National Malaria
Reference Laboratory

Head, Division National AIDS National Public Government

of Vector-borne and STI Control Health Laboratory Chemist
Diseases (DVBD) Programme Service

National Malaria Central Provincial Medical Central

Reference Microbiology Laboratory Reference
Laboratory Laboratory Technologist (PMLT) Laboratory (TB)

District Medical
Laboratory
Technologist (DMLT)

Figure 1.1. Ministry of Public Health and Sanitation

Quality Policy Manual for Medical Laboratory Services in Kenya / 

 Minister for Medical Services

Permanent Secretary

Director of Medical Services (DMS)

Department of Diagnostic and

Forensic Services (DDFS) / Blood
Transfusion Services (BTS)

National Blood
Medico-Legal Services Clinical Laboratory Services
Transfusion Services

Provincial Medical Laboratory

Scientific Officer (PMLSO)

District Medical Laboratory

Scientific Officer (DMLSO)

Figure 1.2. Ministry of Medical Services

1.2.3 Activities of medical laboratories

In Kenya, medical laboratories provide the following services:
diagnostic testing
public health testing
disease surveillance
medico-legal and forensic services
monitoring and control of vector-borne diseases
research and training
blood transfusion services
In accordance with the Maputo Declaration of 2008 and the National Policy Guidelines for the
Medical Laboratory Services of Kenya (2006) the above services are offered at five tiered levels:

 / Quality Policy Manual for Medical Laboratory Services in Kenya

 dispensaries and health clinics: basic laboratory services
health centres and nursing homes: limited laboratory services
primary/district hospitals: laboratory services for inpatients and outpatients
secondary/provincial hospitals: comprehensive laboratory services for inpatients
and outpatients
tertiary/reference/teaching/research centres: highly specialized laboratory
services
There is also a vibrant private health sector in Kenya with stand-alone laboratories or
laboratories as part of health institutions. Private laboratories mainly follow the different
levels of the laboratory services in the public sector as described below.

1.3 Levels of laboratory services

1.3.1 Levels 1 and 2dispensary and health centre laboratories

The National Public Health Laboratory Services (NPHLS) is responsible for all level 1
and 2 laboratories conducting basic laboratory tests at dispensaries, health centres and
nursing homes in the public sector.

1.3.2 Levels 3 and 4district and provincial hospital laboratories

Every district and provincial hospital has a medical laboratory that conducts clinical
testing for inpatients and outpatients. These laboratories are currently under the Ministry
of Medical Services.

1.3.3 Level 5reference and specialized laboratories

The NPHLS currently falls within the Ministry of Public Health and Sanitation and
comprises three reference laboratories:
1 Central Tuberculosis Laboratory conducts specialized and reference testing
for tuberculosis and oversees national quality assurance and training for TB
diagnosis
2 Central Microbiology Reference Laboratory conducts specialized and reference
testing for microbiology
3 National HIV Reference Laboratory is responsible for quality assurance in HIV
testing, specialized HIV testing, training and surveillance
4 The National Blood Transfusion Service Laboratories that conduct specialized
testing and quality assurance on blood collected for transfusion
Other level 5 laboratories are located at national referral teaching hospitals (Kenyatta
National Hospital and Moi Teaching and Referral Hospital) and at the Kenya Medical
Research Institute (KEMRI).
The National Blood Transfusion Service (NBTS) laboratories conduct specialized testing
and quality assurance on blood collected for transfusion. The NBTS falls under the Division
of Diagnostic and Forensic Services within the Ministry of Medical Services.

Quality Policy Manual for Medical Laboratory Services in Kenya / 

Contacts
Further information on the services provided and contact telephone numbers are available
at:
Ministry of Public Health and Sanitation
Department of Disease Prevention and Control
PO Box 19982 00202
Nairobi
Email: [email protected]
Website: www.health.go.ke
Tel: +254 20 2717077
Fax +254 20 2713234

Ministry of Medical Services

Department of Diagnostic and Forensic Services
PO Box 30016 00100
Nairobi
Email: [email protected]
Website: www.psph.go.ke
Tel: +254 20 2717077
Fax +254 20 2713234

Key messages

Laboratory services support the following health service components: curative,

preventive, health promotion, surveillance, research and training
Laboratory services are offered at five levels: dispensaries and health clinics,
health centres and nursing homes, primary/district hospitals, secondary/
provincial hospitals and tertiary/reference/teaching/research centres
Medical laboratories in Kenya provide the following services: diagnostic testing,
public health testing, disease surveillance, medico-legal services, monitoring
and control of vector-borne diseases

 / Quality Policy Manual for Medical Laboratory Services in Kenya

CHAPTER 2: LABORATORY QUALITY POLICY, STRATEGY
AND GOALS

2.1 Quality policy

Medical laboratories in Kenya shall work within the framework of the quality management
system and design their services specifically to:
support the national vision, mission and values for health service delivery
improve customer satisfaction, work area health and safety
promote quality in the delivery of medical laboratory services
comply with ISO 15189 or equivalent standards and applicable regulations

2.2 Quality statement

Medical laboratories in Kenya shall achieve testing excellence and customer satisfaction
by continually improving processes to ensure they consistently meet or exceed customer
requirements.

2.3 Quality goal

The overall quality goal of medical laboratories in Kenya is to achieve continuous
improvement based on the QMS aligned to ISO 15189 or equivalent standard. Laboratory
manager/directors shall monitor and measure performance of processes within their
laboratories and establish achievable, appropriate, sustainable and measurable quality
indicators.

2.4 Vision, mission and value statements of the medical laboratory

services

2.4.1 Vision
To provide efficient and quality medical laboratory services that are accessible, equitable
and affordable for all citizens.

2.4.2 Mission
To provide effective, efficient, accessible, equitable and affordable medical laboratory
services that support diagnosis and management of patients, disease surveillance, medical
research, training and national health policy formulation.
To realize the mission, medical laboratories in Kenya shall:
strive to establish technical excellence and superior quality in testing
seek input from customers to assess their satisfaction with services
address issues that are important to customers in a timely manner

Quality Policy Manual for Medical Laboratory Services in Kenya / 

 meet all customer and regulatory requirements according to relevant national and
international standards
continuously evaluate and improve services
ensure this policy is communicated to and understood by all health staff

2.5 Scope and purpose of the Quality Policy Manual for Medical Laboratories
in Kenya

2.5.1 Scope of the Quality Policy Manual

The scope of this Manual is applicable to all medical laboratories in the Republic of
Kenya
The quality management system (QMS) policies are linked and aligned with the
policies and processes of the national health authorities in Kenya
The QMS policies set out in this Manual are applicable to all personnel working in
medical laboratories
All medical laboratory personnel shall be responsible for maintaining quality in all
medical laboratory processes

2.5.2 Purpose of the Quality Policy Manual

Specifies the quality system elements, responsibilities and requirements for quality
management of medical laboratory services
Covers the organizational management, resources and quality assurance activities
required to ensure that pre-examination, examination and post-examination
activities of the medical laboratory services are conducted in a manner that meets
the needs of all users
Guides medical laboratory practice to attain international standards
Outlines quality elements of the medical laboratory services in a manner that can
be readily understood by all staff
Serves as an introduction of the laboratory QMS to medical laboratory regulatory
and professional bodies in Kenya, and to laboratory customers

2.6 Structure of the laboratory Quality Policy Manual

Consistent with international laboratory standards, ten (10) quality system elements (QSE)
have been established in Kenya and are described in detail in the subsequent chapters of
this manual. These elements are:
laboratory organization and management
personnel
work area health and safety management
laboratory equipment management
laboratory supplies management
specimen collection, processing and reporting

 / Quality Policy Manual for Medical Laboratory Services in Kenya

 quality assurance in the medical laboratory
quality documentation and technical record management
laboratory information management system
laboratory communication management

Background information
Berte, Lucia M. Clinical laboratory technical procedure manuals; approved guideline, 5th ed.
GP02-A5. Clinical and Laboratory Standards Institute, National Committee for Clinical
Laboratory Standards, 2006. ISBN1562-386-00X.

Key messages

The Quality Policy Manual for Medical Laboratories in Kenya is based on ISO 15189
or equivalent standard.
The scope of the Quality Policy Manual encompasses quality management and
technical components of QMS.
The Quality Policy Manual will familiarize laboratory staff with methods of
complying with QSE requirements and facilitate the implementation and
maintenance of quality in each of the QSE.

Quality Policy Manual for Medical Laboratory Services in Kenya / 

CHAPTER 3: LABORATORY ORGANIZATION AND
MANAGEMENT

3.1 Purpose
The purpose of this quality element is to ensure that a formal and documented organizational
and management structure within the laboratory, depicting the interrelationship and roles
of all laboratory staff, is established and understood. This element enhances efficiency and
accountability, and also ensures that adequate human resources are available to support
quality laboratory services.

3.2 Policy
The medical laboratory shall be a clearly defined entity or department within the parent
institution or stand-alone, and shall focus on providing laboratory services that meet ISO
15189 or equivalent standards. The laboratory organizational and management structure
shall establish responsibility and authority to support quality functions of the laboratory
and each health facility as a whole. The laboratory shall achieve this through:
appointing a laboratory manager/director and quality manager
establishing a laboratory quality management team within the institution
responsible for all quality aspects of the laboratory services. The team composition
shall comprise the laboratory manager/director, quality manager, a safety officer
and section heads, as appropriate
designing an organizational structure with clear reporting lines, and establishing
responsibilities. There shall be a clear relationship between the laboratory and the
institution
establishing a programme for internal and external quality audits in the
laboratory
continually reviewing and improving the quality management system activities
against set standards such as ISO 15189
ensuring availability of appropriate functional equipment and maintaining
an uninterrupted supply of required chemicals, reagents, test kits and other
consumables
ensuring availability of adequate numbers of appropriately qualified and competent
staff
ensuring a programme of continuous quality improvement in the laboratory
ensuring all laboratory environment and safety needs are met
ensuring relevant data is available for planning and policy development

10 / Quality Policy Manual for Medical Laboratory Services in Kenya

3.3 Responsibilities

3.3.1 Laboratory manager/director

The laboratory manager/director shall have overall responsibility for planning, delivering
and maintaining quality laboratory services including:
appointing personnel to key positions essential for meeting the laboratory objectives
including a quality manager and safety officer
designating deputies for all key positions
defining lines of authority and the interrelationship of personnel
defining laboratory services and improvement activities both internally and in
collaboration with relevant stakeholders
defining key performance indicators and collecting and analysing data to ensure
continuous quality improvement
providing consultation and advice relating to professional and technical issues
planning the laboratory operational budget and securing funding
managing the laboratory to ensure efficient and effective medical laboratory
services within available resources
ensuring an adequate number qualified personnel to provide quality laboratory
services
preparing and implementing relevant personnel development and training plans
addressing complaints or suggestions from laboratory customers and laboratory
staff
implementing the laboratory quality management system

3.3.2 Laboratory quality manager

The laboratory quality manager reports directly to the appointing authority and establishes
and maintains the laboratory quality management system (QMS). Specific duties and
responsibilities of the quality manager include:
defining the quality system and operational standards, and applying them to
monitor and improve the quality of laboratory services
implementing a safe laboratory environment in compliance with good clinical and
laboratory practice and applicable regulations
providing guidance on relevant standards and regulatory requirements
collaborating with laboratory staff in developing and documenting appropriate
policies, processes and procedures for their activities
coordinating internal audits of the laboratory and ensuring participation in relevant
proficiency testing schemes
communicating information about the performance of the QMS and distributing
quality tools such as worksheets, forms, maintenance logs and audit checklists to
laboratory staff

Quality Policy Manual for Medical Laboratory Services in Kenya / 11

3.3.3 Laboratory technical staff
The specific responsibilities of laboratory technical staff include:
providing quality and timely test results
analysing laboratory data and providing reports
maintaining a safe working environment
ensuring optimal functioning of all laboratory equipment
following quality policies and procedures applicable to all tasks performed
providing advice on relevant samples and pre-test information to patients
interpreting test results as appropriate

3.3.4 Laboratory support staff

The specific responsibilities of support staff (receptionist, ICT, cleaners, phlebotomists and
others as appropriate) include:
maintaining a safe working environment
ensuring optimal functioning of all laboratory and other equipment
adhering to quality policies and procedures applicable to all tasks performed
data collection, analysis and presentation for policy development

3.4 Laboratory organizational structure at facility level

Laboratory services within hospital facilities are managed by the laboratory director/
manager, who reports directly to the hospital superintendent and the laboratory
representative in the hospital health management team (HMT). Reporting to the laboratory
director/manager are the quality manager and the deputy laboratory manager/director,
who have distinct roles and responsibilities. The quality manager heads the quality
assurance team within the facility and is responsible for all matters related to quality
assurance. The quality manager oversees all the sections in the laboratory and addresses the
implementation of quality assurance. The deputy laboratory director/manager supports
the laboratory director/ manager and is responsible for administrative issues relating to
the laboratory. The laboratory manager/director is overall responsible for all quality and
administrative issues in the laboratory.
Figure 3.1 shows a suggested facility-level organogram for the laboratory.

3.5 Quality management systems

3.5.1 Management review

The head of each laboratory (laboratory director/manager or laboratory in charge) and the
laboratory management team (which usually comprises the laboratory director/manager,
deputy laboratory manager, quality manager, safety officer and section heads) shall review
the laboratorys quality management system and its medical services provision, including
examination and advisory activities, to ensure their continuing suitability and effectiveness
in supporting patient care, and to introduce any necessary changes or improvements. The

12 / Quality Policy Manual for Medical Laboratory Services in Kenya

results of the review shall be incorporated into a plan that includes goals, objectives and
action plans. The laboratory management shall review this manual once every two years.

Medical superintendent

Laboratory director/
PMLT / DMLT Laboratory in charge

Deputy laboratory
in charge

Safety officer Quality manager

Section head Section head Section head Section head

Lab technologists Lab technologists Lab technologists Lab technologists

Figure 3.1. Facility-level laboratory organogram

Background information
International Organization for Standardization (ISO). Medical laboratoriesparticular
requirements for quality and competence. ISO 15189: 2007, 2nd ed. Sections 4.1 Organization and
management, 4.2 Quality management system, 4.15 Management review, Annex C.10 Financial
arrangements.

Key messages

The laboratory is an essential component of the health facility services.

The laboratory must have an organizational structure supportive of quality
services delivery.
To maintain quality laboratory services, the laboratory manager/director must
assure the quality performance of qualified staff by retraining and motivating
them.

Quality Policy Manual for Medical Laboratory Services in Kenya / 13

CHAPTER 4: PERSONNEL

4.1 Purpose
Attention to qualified personnel ensures that laboratory services are provided with
adequate numbers of appropriately qualified and competent staff who have specific job
descriptions and opportunities for professional growth and development.

4.2 Policy
Medical laboratories shall be staffed with qualified and competent personnel. Each medical
laboratory shall be managed and directed by a laboratory director/ manager or in charge
who is competent to undertake the responsibility for the services provided. Deputies
shall be appointed to key positions to ensure uninterrupted services and continuing staff
development.
Medical laboratory personnel must:
be appropriately qualified as defined by national standards
be registered by the relevant professional body according to health authority
regulations
be competent to perform relevant testing
engage in continuing professional development according to the regulations of
relevant professional bodies

4.3 Responsibilities

4.3.1 Laboratory manager/director

The laboratory manager/director:
ensures overall compliance of the laboratory with established quality standards,
and has direct responsibility for laboratory activities, including final approval of
all documents
participates in the recruitment of appropriately qualified and competent staff
coordinate staff training and professional development

4.3.2 Quality manager

The quality manager (QM) has responsibility for the overall laboratory quality system
and its implementation. The QM has a defined position in the laboratory management
structure to ensure decisions taken on laboratory quality policies and resources are properly
implemented. In laboratories with few personnel, the QM may also be the laboratory
manager/director. When the QM officer is not present, a deputy shall be appointed. The
QM shall:
ensure the laboratory participates in relevant proficiency testing schemes and inter-
laboratory collaborative studies

14 / Quality Policy Manual for Medical Laboratory Services in Kenya

 ensure every laboratory staff participates in processing EQA samples
develop and update quality documents based on this manual and train laboratory
staff in their use
coordinate staff training on all aspects of quality management systems
Note: Specialized or small laboratories may be limited in terms of staff numbers. One person
or a part-time person may operate these laboratories. In these cases, one person may have the
responsibilities of both technical and quality manager. Special care and precautions must be taken
and documented to ensure that a limited number of laboratory staff does not adversely affect the
quality of the laboratory services and implementation of a quality system.

4.3.3 Laboratory technical staff

Laboratory technical staff shall be responsible for:
performing daily activities in the laboratory
reading and following SOPs, performing appropriate quality control checks, and
implementing corrective actions
participating in staff training and continuing professional development

4.4 Procedures and processes

4.4.1 Staff recruitment, orientation and induction

Qualifications shall be assessed when an employee is recruited, changes position or when
the requirements of a position change. The laboratory manager/director shall maintain
records of qualifications of all employees. If there are differences between an employees
qualifications and the requirements for the job, training or other appropriate action must
be taken to provide the employee with the necessary competence for the job, or if possible,
staff reallocation shall take place.
The laboratory manager/director shall ensure that qualified and competent personnel are
employed for every position. A comprehensive orientation and induction programme,
which includes but is not limited to information contained in table 4.1, shall be developed
for new members of staff. A signed record shall be kept of the induction programme and
placed in the employees file.

4.4.2 Competency assessment

Competency assessment shall be performed before staff performs a test for the first time
or at any time there is a change in instrument type, personnel or method. The laboratory
manager/director shall maintain data demonstrating the capability of each staff member to
meet performance criteria for specific laboratory tests including through analysing internal
quality control results. Proficiency assessments shall be carried out immediately after
employment, after six months, and then annually thereafter. Records of the competency
assessment shall be kept in individual personnel files to document areas of competency.

Quality Policy Manual for Medical Laboratory Services in Kenya / 15

Table 4.1. Personnel orientation programme

Orientation programme Suggested content

Organization orientation Organizations mission statement and quality policy
General orientation and organogram
Conditions of employment (employee handbook)
Employee benefits
Facility tour
General safety structures
Hazard communication
Fire preparedness
Disaster preparedness
Communication systems (telephone, fax, e-mail, alarms)
Laboratory orientation Departmental mission, vision, and quality policy
Area/ facility/ laboratory tour
Departmental terminology
Departmental rules and policies
Dress requirements
Work schedule and assignments
Code of ethics

4.4.3 Training and education

Training of new employees
The laboratory director/ manager shall review every individual staff members level
of qualification, experience and skills against the laboratorys job requirements before
assigning an employee to the laboratory. All new employees shall be inducted into the
laboratory and orientation programme developed to provide new staff with adequate
information on laboratory operations, test methods, quality control procedures, and
records management for them to be able to completely perform their duties.
Table 4.2 suggests topics for a training programme for new laboratory staff.

Continuing professional development

Access to continuing education is important for all medical laboratory staff. All staff shall
be given the opportunity for further training in relation to the needs of the service and
their own professional advancement according to their personal professional development
plan. Resources for training shall be made available. These include:
library and information
staff attendance at meetings, workshops and conferences
staff participation in short courses

16 / Quality Policy Manual for Medical Laboratory Services in Kenya

Table 4.2. Training programme for new employees

Component Contents
Quality training Quality management systems
Organizations/services quality management system
Organizations problem-solving approach
Services quality assurance programme
Services quality control programme
Employees expected roles in each of the above to include:
Receiving training
Maintaining competence
Following procedures as written
Reporting complaints and non-conformances
Practising good customer service skills
Collecting data for quality indicators and monitoring
Participating in quality improvement teams
Laboratory safety training Organizations general safety
Hazard communicationgeneral
Fire preparedness
Disaster preparedness
Accident reporting system
Laboratory safety training Laboratory-specific safety
Infection prevention and control
Disposal of hazardous waste
Personal protective equipment
Chemical hygiene plan
Radiation safety
Bioterrorism preparedness
Job-related training All work processes and related procedures, especially records
management, reporting and information management

4.4.4 Personnel records

The laboratory manager/director shall maintain personnel files containing:
personal details
employment records
approved job description
terms and conditions of employment
record of staff induction and orientation
records of academic and professional qualifications
current CV
accident or incident records
records of annual appraisals
competency assessment records
records of training courses, seminars, and workshops

Quality Policy Manual for Medical Laboratory Services in Kenya / 17

 relevant attestation records
confidentiality statement
health and safety records
regulatory body compliance requirements and records

4.4.5 Job descriptions

Written job descriptions and contracts shall be provided to enable staff to know and
understand their roles and responsibilities. Job descriptions shall include:
job title
position within the organizational structure
accountability
main duties and responsibilities
agreement by staff member after joint review
date and signature of staff and supervisor
Managerial and technical medical laboratory personnel shall be equipped with the
authority and resources to perform their duties to the required level as defined in section
4.3. The laboratory manager/director may amend this section to reflect the titles and
responsibilities of the personnel in their laboratory as necessary or appropriate. The titles
and responsibilities may differ based on the type and complexity of the laboratory.

4.4.6 Employee performance appraisal

Achievement of medical laboratory and personal career objectives shall be facilitated by
regular staff appraisal. The laboratory manager/director shall ensure that staff participate
in annual appraisals that consider:
stated objectives and plans for the medical laboratory
job description of each staff member
performance of tasks carried out during the year
personal objectives of each staff member
training and development needs of each staff member

Background information
International Organization for Standardization (ISO). Medical laboratoriesparticular
requirements for quality and competence. ISO 15189: 2007, 2nd ed. Section 5.1: Technical
requirementspersonnel.
International Organization for Standardization (ISO). Quality management systems
requirements. ISO 9001: 2008. Section 6.2 Human resources.
Kenya. Ministry of Health. National policy guidelines for the medical laboratory services of
Kenya. Nairobi: National Public Health Laboratory Services, 2007.

18 / Quality Policy Manual for Medical Laboratory Services in Kenya

Key messages

Laboratory procedures shall be performed by competent, qualified and motivated

staff.
Every laboratory shall have a comprehensive orientation and induction
programme for both new and serving staff.
Laboratory staff shall routinely demonstrate competence through documented
proficiency assessment and shall be provided with opportunities for continuing
professional development and training.

Quality Policy Manual for Medical Laboratory Services in Kenya / 19

CHAPTER 5: WORK AREA HEALTH AND SAFETY
MANAGEMENT

5.1 Purpose
Work area health and safety management ensures that the medical laboratory work area
is adequate and safe for laboratory staff, patients and clients by using accepted safety
practices for handling equipment, infectious agents and other hazardous materials. This
quality element also ensures oversight on training and provision of information on safety,
establishment of safety procedures and a regular update of safety practices.

5.2 Policy
The medical laboratory shall provide adequate space, facilities and utilities designed to
optimize work efficiency; minimize the risk of injury and occupational illness; protect
workers, patients, clients and visitors from recognized hazards; and meet applicable
standards for facilities and the environment.

5.3 Responsibilities
Workplace health and safety is the responsibility of all medical laboratory workers. A
safety officer shall be appointed to oversee the implementation of the safety policy. Special
measures and procedures shall be taken to ensure good housekeeping and safe work
practices in the laboratory, including a regular update. Neither urgency nor convenience
is an acceptable excuse to deviate from prescribed safe laboratory working practices. The
following shall be instituted:
A safety officer shall be appointed to draw up the safety policy and associated
SOPs for the laboratory.
The safety officer shall be responsible for ensuring the implementation and
maintenance of all safety procedures described in this manual.
The quality manager shall be responsible for ensuring regular review and control
of the safety and security policy and procedures.
The laboratory manager/director shall be responsible for ensuring implementation
of the safety and security policy and procedures.
All employees shall be responsible for complying with the workplace health
and safety regulations and procedures.

5.4 Procedures
Every medical laboratory shall establish a safety policy according to the Kenya Occupational
Health and Safety Act (2007), addressing the following:
separation and appropriate disposal of laboratory waste
protection of laboratory personnel to avoid occupational hazards
management of post-exposure prophylaxis

20 / Quality Policy Manual for Medical Laboratory Services in Kenya

 provision of personal protective equipment
use of ionizing radiation and non-ionizing radiation
development of a chemical hygiene plan
universal precautions
documentation of all incidents and accidents
relevant immunization of laboratory staff
fire emergencies
first aid
physical security
designated clean and dirty areas
action to be taken when accidents occur in a laboratory

5.4.1 Reporting emergencies

All emergencies within the laboratory shall be documented and reported to the safety
officer and laboratory director/manager, or designees. Telephone numbers shall be
provided for this purpose and checked periodically to ensure that they are functional.
When reporting an emergency, the caller shall state:
name of caller
nature of emergency
building name and precise location (i.e., room number, etc.)
required emergency equipment, e.g. ambulance, fire-fighting equipment (fire
extinguishers, hoses) first aid equipment
number of exposed or affected persons/individuals

5.4.2 Fire emergencies

Fire extinguishers that are regularly serviced shall be available in each laboratory.
Employees shall be trained in the proper use of fire extinguishers on an annual basis. Fire
drills shall be carried out at least annually. In the event of a fire emergency, all persons
shall immediately evacuate the fire area to a designated fire assembly point.

5.4.3 First aid

All laboratory staff shall be provided with basic training in first aid. First aid kits shall be
available in the laboratory containing approved items, and the state of the contents shall
be checked regularly. In the event of an injury, the laboratory staff shall be referred to the
clinician immediately after first aid is given.

5.4.4 Personal protective equipment

The laboratory shall ensure that adequate personal protective equipment (PPE) is available
and that employees use it effectively. The safety officer is responsible for identifying those
tasks that require the use of PPE and for ensuring staff comply with PPE requirements.

Quality Policy Manual for Medical Laboratory Services in Kenya / 21

5.4.5 No smoking or eating in the laboratory
The laboratory manager/director or safety officer must strictly enforce No Smoking and
No Eating regulations throughout the laboratory. No Smoking signs must be placed
specifically in areas where staff are working with flammable gases, liquids, vapours and
other combustible materials. The laboratory shall provide a designated area for staff
meetings and for taking food and drinks.

5.4.6 Universal safety precautions

The following shall be included in annual safety training:
storage and handling of flammable and combustible liquids
eye protection
use of compressed gas cylinders
The laboratory director/manager or safety officer shall enforce a controlled access
policy to the laboratory. Students and visitors are not permitted to enter the laboratory
without the permission of the laboratory manager/director. Students and visitors must
be clearly identifiable through wearing name tags or different coloured laboratory coats.
Unauthorized experimentation in laboratories shall be strictly forbidden. Staff wishing to
use the laboratory for personal research shall obtain written permission from the laboratory
director/ manager and ethical clearance from an appropriate body, where applicable.
All specimens shall be treated as potentially infectious. If in doubt, personnel shall seek
guidance from the laboratory safety officer.
All laboratory staff and students shall be aware of the safety facilities in the laboratory,
including location of safety showers, eyewash stations, fire extinguishers and emergency
exits.
Working stations shall be kept clean and free of clutter at all times. Broken glass, sharps and
laboratory waste shall be properly separated and placed in marked bins in the laboratory.
No waste shall be left or placed in sinks, and under no circumstance shall waste be flushed
down the sink unless authorized to do so by the laboratory safety officer.

5.4.7 Laboratory security

The medical laboratory shall be protected from unauthorized access due to the
confidentiality of the materials handled and data generated, and for the safety of staff,
patients and visitors. This requirement applies to all health facility employees. Specific
laboratory procedures may overrule this stipulation to accommodate legal requirements;
however, the laboratory director/manager must approve any deviation from established
procedures. The following procedures shall be observed:
Access to information associated with patient tests shall be limited and controlled
by the laboratory manager/director.
Theft or disappearance of any physical asset (laboratory equipment, computer,
printer, item of office furniture) shall be reported immediately to the laboratory
director/ manager. The laboratory director/ manager is responsible for reporting

22 / Quality Policy Manual for Medical Laboratory Services in Kenya

 the incident to the medical superintendent, HMT or local security agencies.
Damaged or non-working locks, readers or alarm pads shall be reported immediately
to the laboratory manager/director.
All security incidents shall be reported to the laboratory manager/director.
Significant security incidents, e.g. those involving fraudulent activity, falsification
or adulteration of data, loss of data, or external breaches of network security, shall
be reported immediately to the facility HMT for action.
Security incidents shall be formally documented and shall contain the following
minimum information:
o cases reported
o corrective action proposed
o implementation
o review and follow up of corrective action
o close out

Background information
International Organization for Standardization (ISO). Medical laboratoriesparticular
requirements for quality and competence. ISO 15189: 2007, 2nd ed. Sections 5.2 Accommodation
and environmental conditions, Annex B.2 Environment.
International Organization for Standardization (ISO). Quality management systems
requirements. ISO 9001: 2008. Section 6.3 Infrastructure, work environment.
Kenya. Government. Occupational Safety and Health Act, 2007 (Act No. 15 of 2007). Kenya
Gazette Supplement, 2007-10-26, No. 111.
Kenya. National Public Health Laboratory Services. National policy guidelines for the medical
laboratory services of Kenya. Nairobi: NPHLS, 2007.

Key messages

An adequate work area assures safety to laboratory staff and enhances quality
standards.
Work area health and safety is the responsibility of all laboratory staff.
Laboratory staff should be routinely trained on safety measures.
Laboratory security is a vital component of work area management and must be
enforced.

Quality Policy Manual for Medical Laboratory Services in Kenya / 23

CHAPTER 6: LABORATORY EQUIPMENT MANAGEMENT

6.1 Purpose
Good laboratory equipment management ensures that equipment* used in the laboratory
for testing is identified, procured, used, monitored, maintained and serviced according to
the manufacturers recommendations.
* According to ISO 15189 or equivalent (2007), 5.3, equipment includes instruments,
reference materials, consumables, reagents and analytical systems.

6.2 Policy
The laboratory manager/director shall maintain processes and procedures to ensure
equipment used is appropriate and is maintained, serviced, stored and used according to
manufacturers recommendations. The policy shall address laboratory equipment that is
donated as well as procured using standard procedures to ensure maximum benefit to the
recipient.

6.3 Responsibilities

6.3.1 Laboratory manager/director

Ensure correct installation and validation of equipment.
Establish an equipment master file and preventive maintenance schedule.
Ensure equipment maintenance contracts and calibration services are established
as required.
Define, document, periodically review and amend purchase agreements.
Regularly evaluate and provide feedback to vendors to ensure expectations of both
the laboratory and the vendors are defined, accepted and met.
Ensure staff operating equipment are adequately trained and competent.

6.3.2 Quality manager

Ensure validation, calibration, maintenance and monitoring of equipment conform
to set schedules and standards.
Set requirements for receiving, inspecting, accepting, storing and inventorying
incoming equipment.
Provide tools for monitoring equipment such as maintenance logs and
worksheets.

6.3.3 Laboratory technical staff

Ensure equipment calibration or verification and validation procedures are
performed.
Ensure proper use and handling of laboratory equipment

24 / Quality Policy Manual for Medical Laboratory Services in Kenya

 Follow schedules for user care and preventive maintenance in accordance with
procedures outlined in equipment maintenance manuals provided by the laboratory
manager/director.

6.4 Procedures and processes

6.4.1 Selection of laboratory equipment

General criteria
The following considerations shall be made before procuring laboratory equipment:
infrastructure: power source including voltage, power interruptions, power
stability; water supply, hardness of water; space
environmental conditions: ventilation, temperature, dust and humidity
laboratory workload, staff availability, skills and training
vendor support, reliability and availability (in-country or region)
availability, stability and temperature sensitivity of reagents, controls and
calibrators
availability of local service, technical and training support
ease of operation, maintenance and calibration
track record of performance (local and/or international)
analytical performance, technical quality (sensitivity, specificity, reliability, level of
detection)
test menu (consider scalability for various volumes)
open or closed test and reagent system
system costs (including equipment, service, reagents, and supplies) and cost per
reported test
service contracts (for analytical types of equipment)
specimen types
throughput
turnaround time
quality control and quality assurance requirements
availability of EQA and inter-laboratory comparisons
data management capability, interface capability
safety
availability of back-up methods
supply chain management capability

Equipment procurement
Before placing an order for laboratory equipment, the following shall be considered:
equipment need
priority

Quality Policy Manual for Medical Laboratory Services in Kenya / 25

 expected workload
work efficiency improvement
availability of funds for purchasing and running costs

Reliability and safety

For reliability and safety the following shall be considered:
evaluations or field-testing reports on equipment performance
effect of high temperature, high relative humidity and dust on performance and
durability of the equipment
safety information on the equipment
references from other users on the equipment
validation of the equipment

6.4.2 Equipment validation and commissioning

Evaluation of the performance of new equipment shall be performed on-site to ensure
proper functioning and provision of accurate and precise results when operated according
to recommended procedures.

6.4.3 Equipment maintenance programme

A programme shall be established for preventive maintenance of laboratory equipment
whose benefits shall include:
improved safety
fewer work interruptions
minimal wastage of reagents
improved quality of results
improved relationship between the laboratory and other facility departments
lower cost of repairs
maintenance of productivity
improved staff confidence and motivation
increased working life of the equipment
shorter turnaround time for tests
All laboratory equipment shall be treated as follows.

Operating an Equipment Maintenance Programme

Suppliers or vendors shall install and train users of equipment on user care and
maintenance, trouble shooting and basic repair. SOPs shall be made available on user
care and maintenance for each item of equipment. User and service manuals shall always
be available detailing operation of the equipment, power requirements and temperature
range over which equipment will perform reliably; equipment control, cleaning and
maintenance; recommended replacement parts and their expected working life; and how

26 / Quality Policy Manual for Medical Laboratory Services in Kenya

to troubleshoot and correct problems. Equipment that does not function properly shall be
labelled as out of use and its use discontinued.
The laboratory shall establish service maintenance contracts and keep maintenance logs
on all major equipment, which shall include the following.
Operating and service manual and cleaning instructions for all equipment shall be
readily available.
Dated service records shall be kept for all equipment.
All equipment shall be monitored regularly to ensure reliable performance.
All equipment shall be handled with care, cleaned regularly and kept in the correct
place at all times.
Equipment shall be reported and repaired immediately if faulty.
The manufacturers recommendations shall be followed for use, storage and
maintenance of equipment.
Government regulations shall be followed when retiring or disposing of
unserviceable equipment (Procurement and Disposal Act).

6.4.4 Inventory management

All equipment information shall be entered into an equipment inventory record containing
the following information:
name of equipment, model and serial numbers
date of purchase
date of commissioning
location in the laboratory
manufacturer and vendor contact information
warranty including expiry date
The inventory number shall be attached to the equipment for ease of reference. Equipment
not in use shall be kept in a store or a lockable cupboard and not in the main working
areas.

6.4.5 Equipment documents and records

Equipment records shall be maintained in the relevant logbooks as follows:

Book of Life
The laboratory shall compile a Book of Life for each item of equipment that has a
predefined schedule for calibration or maintenance. This book shall contain all information
regarding the equipment and shall be retained for the life of the equipment. A Book of Life
shall include:
equipment inventory sheet
service contract information
vendors information records

Quality Policy Manual for Medical Laboratory Services in Kenya / 27

 laboratorys validation plan and records
calibration, maintenance and service schedule
manufacturers notification inserts and alerts

Records
The laboratory shall retain records of scheduled tasks, troubleshooting, documentation of
supervisor reviews or any other equipment-related actions specified by the country policy
or accrediting organization. Records may include:
maintenance records
o reagents log
o maintenance log
o quality control log
o quality control charts
o incidence log
o corrective action log
calibration records
establishment of acceptable range for quality control material records
service and repair records
external peer quality control comparison results and corrective action records
proficiency testing results and corrective action records
decommission records
disposal and removal records
Other equipment-related records shall include those that provide guidance or work
instructions for performing and recording activities like troubleshooting and undertaking
repairs. Examples include:
operators manual
o standard applicable tests

Background information
International Organization for Standardization (ISO). Medical laboratoriesparticular
requirements for quality and competence. ISO 15189: 2007, 2nd ed. Section 5.3 Laboratory
equipment, Annex B.8 System maintenance.

Key messages

Laboratory equipment must be identified, used, monitored, serviced and

maintained according to manufacturers instructions or applicable standards.
The laboratory must have the following documents for all equipment: inventory
record, preventive and maintenance record, operational manuals.
All equipment operational and maintenance records must be available and easily
accessible to staff.

28 / Quality Policy Manual for Medical Laboratory Services in Kenya

CHAPTER 7: LABORATORY SUPPLIES MANAGEMENT

7.1 Purpose
Laboratory supplies management ensures continuous availability and access to quality
laboratory reagents, test kits and supplies in the laboratory.

7.2 Policy
The laboratory manager/director shall establish systems to ensure uninterrupted
availability of chemicals, reagents and supplies necessary to meet quality requirements of
all laboratory procedures.

7.3 Responsibilities

7.3.1 Laboratory manager/director

Determine the laboratory requirements of laboratory supplies on a monthly,
quarterly and annual basis.
Maintain a sufficient stock of laboratory reagents, kits and supplies to meet
laboratory requirements.
Monitor laboratory supplies to ensure no stock-outs or expiry of reagents occurs.
Ensure appropriate storage facilities for all reagents and laboratory supplies,
addressing temperature, security, and space.
Plan, cost, budget, warehouse, stock, manage and promote the rational use of
laboratory supplies within the resources provided.
Account for usage of laboratory supplies.
Ensure that reagents and supplies are stored appropriately according to First
Expiry First Out (FEFO).

7.3.2 Quality manager

Ensure validation and monitoring of reagents and supplies.
Set requirements for receiving, inspecting, accepting, storing and inventorying
incoming supplies.
Provide tools for monitoring reagents and supplies such as bin cards, and issue
and receipt vouchers, such as S11, S12, S13.
Ensure cold chain temperatures are monitored regularly.

7.3.3 Laboratory technical staff

Monitor and report use of supplies
Make supplies requisitions
Carry out lot-to-lot validation, i.e. evaluate a new kit using the existing validated
kit

Quality Policy Manual for Medical Laboratory Services in Kenya / 29

7.4 Procedures and processes
A demand system (pull) shall be instituted where the laboratory specifies and quantifies
its needs based on standard procedures established at national level. The essential supply
list shall be based on recommendations for standardizing tests, techniques and equipment.
This list of essential laboratory supplies shall be made available to all health facilities in
the country. All public laboratories shall follow established government procurement
guidelines. Each laboratory shall establish proper inventory and stores management
procedures.

7.4.1 Commodity flow

When commodities are moved from one place to another, documentation shall be kept to
track each item from ordering and purchase, delivery and receipt, distribution and issuing,
to actual use (figure 7.1).

Good stock and inventory control management shall be established to ensure that routine
activities for ordering, receiving, storing, distributing, recording use and overall tracking
are effective and efficient. Staff shall order for supply and re-supply through written rather
than verbal communication.

Issue and Central/ Regional store

Receipt e.g. Kenya Medical
vouchers Supplies Agency (KEMSA)
(S12, S11
CDRR)
Basic tools
for the
commodity Stock card,
supply chain Temp log, Facility/General store
Expiry
tracking
chart,
Monthly/
quarterly
stock card
Laboratory store
/Laboratory
technologist

Haematology Other
bench laboratories

Biochemistry section
Test activity
5
registers, (DAR)

Figure 7.1. Flow of commodities (From: MSH LCM training curriculum)

30 / Quality Policy Manual for Medical Laboratory Services in Kenya

7.4.2 Ordering laboratory commodities
The laboratory manager/director shall establish an effective inventory management
system that will inform the storekeeper on:
what to order
when to order or issue
how much to order or issue
how to maintain an appropriate stock level of all products to avoid both stock outs
and overstocks, taking into account emergency situations

7.4.3 Considerations for ordering supplies

The laboratory shall make orders based on actual need. The following considerations may
be used to assist in making proper estimates of laboratory requirements:
client focused: certain categories of clients, e.g. infants, pregnant women, and the
elderly
disease burden: to diagnose and manage the priority disease burden in the area
taking into consideration seasonal variations
disease outbreaks or other emergencies: the likelihood of specific disease outbreaks
or other emergency situations occurring
budgetary allocation: to ensure that a certain product accounts for no more than a
designated proportion of the budget

7.4.4 Storage and stock control

Laboratory stocks shall be kept in a room with an environment that is:
cool and dry
free from dust and damp
vermin-proof
secure from unauthorised access
Adequate storage space shall be provided with sturdy shelves and refrigerators (where
needed).

7.4.5 Stock records in inventory management

The following records shall be put in place to ensure proper tracking of items. Stock records
may be manual or computerized.
core records in the inventory management system
primary source of information used in the reordering formulas
source of data used to compile reports
A laboratory logistics management information system (LLMIS) shall be used to collect
and manage the information necessary to support sound and objective decision-making
in managing the supply chain. This information will assist in avoiding stock-outs and

Quality Policy Manual for Medical Laboratory Services in Kenya / 31

preventing overstocks with possible expiry of reagents. These systems assist with:
collection of data
processing the data
generating reports from this data to support decision-making

Bibliography
Kenya. Medical Laboratory Services of Kenya. National strategic plan 20052010. Nairobi:
National Public Health Laboratory Services, 2007.
Laboratory Commodity Management curriculum training manual. MSH. August 2010
Kenya. Ministry of Health. National policy guidelines for the medical laboratory services of
Kenya. Nairobi: National Public Health Laboratory Services, 2007.
Tanzania. Ministry of Health and Social Welfare. Human resource for health: strategic plan
20082013. Dar es salaam: Ministry of Health and Social Welfare, January 2008.

Key messages

For continuous availability of reagents and supplies, laboratories must establish

inventory systems for stock and control management.
Laboratories are encouraged to invest in a LLMIS to effectively manage the
supply chain.
Besides ensuring continuous availability of commodities, LLMIS is useful in
generating reports and data to support decision-making.

32 / Quality Policy Manual for Medical Laboratory Services in Kenya

CHAPTER 8: SPECIMEN COLLECTION, PROCESSING AND
REPORTING

8.1 Purpose
Specimen collection processing and reporting ensures quality in all pre-analytical, analytical
and post-analytical procedures by providing guidance on the correct management of
laboratory specimens to promote accurate test results.

8.2 Policy
The laboratory shall have written procedures for specimen collection, identification,
transportation, testing, analysing and reporting results. The procedures shall include, but
not be limited to, collection, receipt and rejection, analysis, and storage and disposal of
samples.

8.3 Procedures

8.3.1 Pre-analytical procedures

Establish and document specimen management processes and procedures

The following procedure shall be used for handling specimens in the clinical laboratory:
Identify the right patient
Collect appropriate specimen(s) of good quality at the appropriate time
Label the specimens appropriately
Transport specimens to the laboratory within the specified time and under
recommended conditions
Ensure proper accessioning in laboratory
Perform the correct analysis
Document and report the results
Submit the report to user in a timely manner

Inform users
Inform all laboratory users of specimen management processes, and conduct training if
necessary.

Laboratory request forms

Ensure the relevant laboratory request forms are available. The following information
shall be included on all laboratory request forms:
Patients names, date of birth, gender, medical registration number (IP/OP),
physical address, telephone number (where known)
name of facility, clinic or ward

Quality Policy Manual for Medical Laboratory Services in Kenya / 33

 nature of specimen and test required
body site from where the specimen is taken (where applicable)
date and time of collection.
clinical details, e.g. signs and symptoms, clinical impression, current medication,
including antibiotic treatment
name, signature and address (where applicable) of requesting clinician

Specimen identification and receipt

The following procedures shall be adhered to:
All patient samples, specimen types, and aliquots shall be positively identified by
attaching a label to them. The label MUST NEVER be attached to the lid of any
specimen container.
Specimens shall be labelled with at least two of the patients names written in full,
the laboratory accession number, patient registration number (IP/OP), collection
date and time, and name of the person collecting the sample. Once a laboratory
information management system (LIMS) is established, all specimens received
and/or collected by the laboratory shall be identified by a barcode label, which
is generated by the LIMS. The label shall be applied to each tube of blood or
specimen container based on the identification policy to avoid sample mix-ups
and mislabelling.
All aliquots shall be labelled with information similar to the source specimen.
Sample identification data shall be transferred immediately into the laboratory
register, which shall include time of specimen receipt and identification of the
person receiving the specimen.
Where a hospital information system and LIMS have been established, the
laboratory manager/director shall establish procedures for the following: specimen
identification and accessioning system, specimen requisition, verbal requests for
patient testing, and positive identification of samples.
The request form and specimen container shall be reviewed to verify:
o completeness of the requisition and integrity of the specimen
o adequacy of the specimen
o appropriate labelling, legible identification
o appropriateness of the specimen submitted for the requested test
Procedures for handling sub-optimal specimens, including specimen rejection
criteria, shall be enforced.

Verbal requests for tests

For verbal test requests, for example by telephone, the person taking the order shall
enter the request in a verbal test logbook before transferring the information onto a test
requisition form that must include all the necessary information, including the name of
the person making the order. The person taking a verbal order must read back the entire
order to ensure accuracy.

34 / Quality Policy Manual for Medical Laboratory Services in Kenya

Specimen collection
The laboratory shall establish procedures for:
Positively identifying the patient before collecting a specimen
identifying the required specimen for each test
preparing the patient
selecting type of collection container, required volume, timing
preserving specimens such as transport media
proper specimen labelling
special handling instructions, such as refrigeration or bio safety level 3 samples
Note. Special care shall be taken not to over-fill or under-fill blood collection tubes.

Transporting samples
Patient confidentiality must be maintained at all times.
Specimens must be packaged and preserved appropriately.
Appropriate temperature and transit times must be maintained.
International Air Transport Association (IATA) regulations must be adhered to.
Specimens shall be placed in the specimen transport bag with the request form in
a separate pouch, which must be attached.
Specimens shall not be transported in mail envelopes.
Staples and pins shall not be used.
Accidents involving specimens shall be dealt with immediately and documented
and investigated.
Specimens shall be labelled with a biohazard label during transportation.

Specimen referral
All specimens sent to referral laboratories shall be collected and handled according
to the precise requirements of the policy of the referral laboratory. These include
specimen temperature, transport time and separation of cells from serum or plasma
and slide fixation.
Detailed patient information must be provided in all cases.
Attention shall be given to proper filling of specimen containers.
All specimens including histology, cytology, 24-hour urine and microbiology
specimen and reason for rejection. This data shall become part of the laboratory
quality improvement records.

8.3.2 Analytical procedures

Testing of specimens
For every test, there shall be an easily accessible, approved SOP.
Only competent staff shall perform laboratory testing.

Quality Policy Manual for Medical Laboratory Services in Kenya / 35

 Expired reagents shall not be used.
Internal quality control procedures shall be performed, documented, and reviewed
prior to release of patient results. Quality control results shall be monitored for
biases, shifts, and trends through use of charts, for example, Levy-Jennings charts,
and violations shall be followed up by timely troubleshooting and corrective
action.

Test validation
Before releasing results, test results shall be cross-checked against test requests to
ensure they have been fully addressed.
The laboratory supervisor or designee shall review all laboratory results to ensure
there are no errors in reporting before dispatch.
A signature shall be appended on each report confirming the supervisors review.

8.3.3 Post-analytical procedures

Reporting results
Laboratory report forms shall include the following information:
patient name, date, age, gender
location code (ward, room number, outpatient clinic)
patient registration number
patient laboratory number
name of attending clinician
test(s) requested, collection date and time
test results, normal reference values (where applicable)
laboratory comments and interpretation (where applicable)
condition of specimen (where applicable)
date and time of analysis
testing technicians and supervisors signature
Legibility is crucial and only universally accepted abbreviations shall be used.
Critical values notification shall be done in accordance with the laboratory policy that
states agreed test result limits beyond which notification shall be urgently made. The
critical value notification register shall be filled in, indicating who was notified and who
the notifier was, with signature. Where a telephone call is made, the person to whom the
results were relayed, with time, location and initials of the laboratory staff making the call,
shall be documented in the logbook. The notifying staff shall also ask the person to read
back the results to ensure accuracy. All of the above shall be recorded in the laboratory
register or electronic database.

Turn-around time
Every laboratory shall establish a turn-around time (TAT) for every test, in

36 / Quality Policy Manual for Medical Laboratory Services in Kenya

 consultation with the clinicians. In general, results of basic tests shall be made
available within 2 hours and more complex tests within 24 hours, unless tested in
batches.
Laboratories shall also establish shortest turn-around times (STAT) for specified
tests that may be urgent, in consultation with the clinicians.
Each laboratory shall determine TAT for all tests including histology, cytology, bone
marrow examinations, tests referred to outside laboratories, and certain special
tests that are run in batches.
Preliminary blood culture results shall be reported within 6 days; final reports
within 2 weeks.
All patient care requestors shall be notified in writing of all TATs, STATs and any
interruption in laboratory services

Retention of records, specimens and slides

All laboratory test result records shall be maintained for not less than 10 years as
stipulated by the Public Archives and Documentation ServiceAct, 1990.
Records of instrument maintenance shall be retained for the life of the instrument.
Each laboratory shall establish appropriate policies on duration of storage of
samples and slides.
Serum, plasma and body fluids are refrigerated and retained for 48 hours; whole blood
and urine specimens are refrigerated and retained for 24 hours; blood films, permanently
stained body fluid slides, and microbiological slides are retained for 7 days; and pathology
slides are retained for 10 years. Tissue blocks are retained indefinitely (See Appendix 1).

Specimen disposal
Laboratory manager/directors shall:
develop a policy for disposal of medical waste that:
o establishes and follows disinfection and sterilization procedures
o complies with national regulations (in this case, those of the National
Environment Management AgencyNEMA) established by the
Environmental Management and Coordination Act (EMCA) No. 8 of 1999
o includes a policy of disposal of rejected specimens
appoint a staff with oversight responsibilities for specimen disposal
establish a schedule to review and dispose of all stored specimens, as appropriate

Background information
College of American Pathologists. So you are going to collect a blood specimen: An introduction
to phlebotomy, 7th ed. Northfield, IL: College of American Pathologists, 1996.
International Organization for Standardization (ISO). Medical laboratoriesparticular
requirements for quality and competence. ISO 15189: 2007, 2nd ed. Sections 5.4 Pre-examination
procedures, 5.5 Examination procedures, 5.7 Post-examination process, 5.8 Reporting results.

Quality Policy Manual for Medical Laboratory Services in Kenya / 37

Kenya. Ministry of Health. National policy guidelines for the medical laboratory services of
Kenya. Nairobi: National Public Health Laboratory Services, 2007.
United States of America. Department of Health and Human Services, Centers for
Medicare and Medicaid Services (Health Care Financing Administration). Clinical
laboratory improvement amendments of 1988: final rule. Federal Register, 1992 (Feb 28): 7162
7164 (42CFR493.1105-493.1213).
United States of America. National Institute for Occupational Safety and Health. Preventing
allergic reactions to natural rubber latex in the workplace. Washington, DC: Department of
Health and Human Services Publication 97-135, June 1997; p. 15.

Key messages

To ensure proper collection and handling of specimens and reagents, the

laboratory must adhere to the cycle of pre-analytical, analytical and post-
analytical procedures.
SOPs must be developed for all laboratory processes.
Laboratories must follow laid-down policies and procedures for disposing of
specimens and medical waste.

38 / Quality Policy Manual for Medical Laboratory Services in Kenya

CHAPTER 9: QUALITY ASSURANCE IN THE MEDICAL
LABORATORY

9.1 Purpose
Quality assurance in the medical laboratory ensures that laboratory processes are controlled
at every stage. Quality assurance (QA) programmes ensure that the results generated by
the laboratory are accurate, reliable, timely and reproducible.

9.2 Policy
The laboratory shall establish a quality assurance programme that clearly defines
procedures for monitoring all events influencing quality of results including establishment
of tolerance limits, number and frequency of controls and tests, corrective action based on
quality control data, and related information. Quality assurance in the medical laboratory
shall be comprehensive and cover all aspects of service delivery from the decision to
request a test to release of the results, and dissemination of data and final disposal of the
specimen.

9.3 Responsibilities

9.3.1 Laboratory manager/director

The overall responsibilities of the laboratory manager/director and quality manager are
described in section 3.3.1 and 3.3.2 respectively. However, with respect to quality assurance,
the responsibilities of the laboratory manager/director shall also include:
implementing the quality management system
enforcing good laboratory practice

9.3.2 Quality manager

Design the laboratory quality management system and oversee its
implementation
Conduct or oversee internal audits of the laboratory
Participate in relevant proficiency testing schemes, and/or inter-laboratory
comparisons
Institute corrective measures for non-conformities identified in audits

9.3.3 Laboratory technical staff

Follow the standard operating procedures and guidelines on quality as stipulated
Carry out quality control and external quality sample testing as recommended in
the relevant standard operating procedures
Participate in making corrective actions for the non-conformities following quality
audits

Quality Policy Manual for Medical Laboratory Services in Kenya / 39

9.4 Quality assurance indicators
The laboratory shall have quality assurance (QA) guidelines to ensure tests generated
are accurate, reliable and reproducible. These guidelines shall address the following QA
indicators:
internal quality control
external quality assessment
stock-outs
equipment downtime
specimen rejections
turn-around time
waiting time

9.5 Reagent storage and calibration

Reagents, reagent kits, chemicals, and quality control and calibration materials
shall be stored according to manufacturers specifications.
All reagents and solutions shall be properly labelled to show identity; lot number,
batch number; storage requirements; date prepared or reconstituted; and expiry
date.
The laboratory shall perform parallel testing when using new lots of reagents or
quality control samples and the laboratory manager/director or designee shall
sign validity checks for each parallel test.
Where calibrators are used as controls, they shall be from a different lot number
than those used to calibrate the method. This procedure shall be approved and
documented by the laboratory manager/director.
The laboratory shall verify the performance specifications of all assays, methods
and equipment and confirm they are fit for the purpose before use. Performance
specifications shall include analytic sensitivity (lower detection limit), specificity,
accuracy, precision and linearity.
Each new lot number or new shipment of microbiology media shall be checked for
sterility and its ability to support growth before being incorporated into patient
testing.

9.6 Internal quality control

The laboratory shall put in place a comprehensive internal quality control (IQC)
programme for all laboratory examinations. This shall include:
o records of date received and expiry, source, quality specification and storage
requirements of IQC material
o the process of validating and verifying IQC material against manufacturers
target values
o acceptance criteria for results obtained on IQC material in use (where
applicable)

40 / Quality Policy Manual for Medical Laboratory Services in Kenya

 o handling out-of-range control results to ensure corrective action is
implemented. All IQC results shall be documented and regularly reviewed,
including corrective action taken
All quality control and calibration results shall be documented. For automated
instruments, quality control and calibration results shall be printed monthly, with
each page reviewed and filed.
Internal quality control shall be carried out through various approaches including
blind rechecking of samples, repeat sample testing, and use of control samples to
check systems and personnel performance.
In addition to using inbuilt quality control material for qualitative tests, external
true positive and negative controls shall be included with each batch, according to
the frequency established by the laboratory.
A designated laboratory technical staff shall review and verify quality control and
calibration results at appropriate times, before laboratory results are reported. The
procedure for reviewing and verifying results shall be documented.
All quality control charts for quantitative assays shall be plotted on Levi-Jennings
charts to detect and identify trends and shifts easily. Levy Jennings charts shall
be interpreted using Westgard rules and appropriate corrective and preventive
action shall be initiated and followed up. The section head in collaboration with
the quality manager shall review and sign all Levy Jennings charts on a monthly
basis.

9.7 External quality assessment

External quality assessment (EQA) is the objective evaluation by an outside agency of the
performance by a number of laboratories on materials of known pathology. The quality
manager shall explore and implement the following:
Enrol in EQA programmes recognized nationally, regionally or internationally
Engage in peer comparisons with other laboratories, especially for tests that are not
supported by EQA
Establish procedures for handling non-satisfactory EQA results. Corrective and
preventive actions shall be taken when the performance of EQA is unsatisfactory,
and all actions documented
Prepare and maintain a database of all EQA results

9.8 Laboratory assessment

9.8.1 Laboratory audits

Four types of audit shall be used to measure laboratory performance and verify compliance
with accreditation or certification and project requirements: internal, external, performance
and management reviews. Based on audit reports, the laboratory manager/director shall
be notified within 24 hours if action is needed when events that cast doubt on the validity
of laboratory results are discovered.

Quality Policy Manual for Medical Laboratory Services in Kenya / 41

Internal Audit
An internal audit is the process of critically reviewing the laboratory by resident laboratory
staff. Once a quality assurance programme has been developed and implemented, the
only way a laboratory can verify its effectiveness is to carry out regular audits. Internal
audits are performed regularly but may be requested as the need arises based on findings
from corrective actions, issues discovered during data review, complaints or data integrity
concerns.
Internal audits shall be planned, conducted and documented in accordance with
written procedure, using a standard checklist. Internal audits verify and evaluate,
through objective evidence, that applicable elements of a quality assurance
programme have been developed and documented and are being implemented.
Internal audits shall be conducted quarterly by trained personnel and shall review
all the elements of quality management system.
Internal audits shall be conducted by the laboratory quality management team, as
directed by the quality manager, and audit reports shall be evaluated to identify
non-conformities, which shall subsequently be addressed.
All personnel who conduct internal audits shall be trained and tested for competence
in auditing.

External Audit
External assessors shall be invited periodically to objectively assess laboratory performance
as a means of continual improvement.
All external audit reports shall be documented and corrective action taken to
address any inconsistencies in practice.
The laboratory manager/director shall ensure that all areas of the laboratory are
accessible to auditors and that appropriate personnel are available to assist in
conducting external audits.

Performance Audit
Performance audits shall include processing of proficiency testing samples, internal single-
blind samples, double-blind samples through a provider, or any other process that tests
the performance of the analyst and the method.

System audit and management review

The laboratory quality management team shall review the laboratory quality management
system at least twice a year and maintain records of review findings and recommended
actions. The review shall cover the status of the laboratorys quality system and the
laboratorys analytical performance to ensure the continuing suitability and effectiveness
of the quality system and laboratory services.

9.9 Occurrence management

Occurrence management is a process of defining and identifying occurrences (events)
that do not conform to the laboratorys established policies, processes and procedures.
42 / Quality Policy Manual for Medical Laboratory Services in Kenya
An occurrence is a non-conforming eventa failure to meet requirements. In addition to
helping uncover and address occurrences, the laboratory quality manager, in consultation
with the laboratory management team, shall develop a plan to help manage and prevent
unwanted incidents.
After an occurrence has been identified, actions shall be taken to rectify the immediate
situation that may include:
establishing the source and cause of the occurrence
identifying the staff involved
reviewing the corrective action taken
establishing preventive actions
Steps shall also be taken to consider the medical significance of the occurrence and the
following actions shall be taken.
Inform the clinicians involved.
Cease further testing and withhold reports until the problem is rectified.
Identify and recall any non-conforming results already released.
Review any pending results before release.
Obtain authorization before resuming testing.
A reporting mechanism of occurrences shall be developed to allow data to be gathered
for analysis. The quality manager shall use all supporting data available to determine the
cause of the occurrence.

Background information
International Organization for Standardization (ISO). Medical laboratoriesparticular
requirements for quality and competence. ISO 15189: 2007, 2nd ed. Section 5.6 Assuring quality
of examination procedures.

Key messages

QA in a laboratory must cover pre-analytical, analytical and post-analytical

phases of laboratory procedures.
Laboratories must enrol in EQA programmes that are recognized nationally,
regionally or internationally.
Laboratories must establish mechanisms for identifying and documenting
incidents and occurrences for corrective action.

Quality Policy Manual for Medical Laboratory Services in Kenya / 43

CHAPTER 10: DOCUMENTATION AND TECHNICAL
RECORDS MANAGEMENT

10.1 Purpose
Proper management of laboratory documentation including technical records ensures
that all necessary documents relating to laboratory processes and procedures, and other
laboratory records, are available and readily accessible.

10.2 Policy
The laboratory manager/director shall establish documented procedures for identification,
creation, control, storage, retrieval, retention time, and disposition of documents and
records. Records shall be maintained in a retrievable and legible manner by authorized
personnel to provide evidence of conformity to ISO 15189 or equivalent requirements
or other approved standards. The document control log (up-to-date master file) shall be
maintained listing all current documents and their locations.

10.3 Responsibilities

10.3.1 Laboratory director/ manager

Is overall in charge of laboratory technical and administrative procedures and
gives final approval for documentation and record management.
Ensures staff have access to current documents needed to perform their work.
Ensures destruction of obsolete documents or records according to established
time periods.
Enforces removal of obsolete documents from the workplace.

10.3.2 Quality manager

Creates and reviews documents and forms.
Oversees accurate and complete creation and review of records.
Archives documents and records as required.
Trains new staff on quality documents.

10.3.3 Laboratory technical staff

Completes documents and forms.
Follows established processes and procedures for creating and revising documents
and forms.
Creates accurate records that conform to laboratory procedures.

44 / Quality Policy Manual for Medical Laboratory Services in Kenya

10.4 Procedures and processes

10.4.1 Quality documents and technical records

Documents and records that are controlled include all laboratory records, requests forms,
policies and procedures. Examples of important documents and records include:

Request forms
test request forms

Reports
incident and accident reports
reports of complaints and corrective actions taken
IQC and EQA reports
internal and external audit reports

Records
staff training and competence records
laboratory correspondence
records of test results and equipment printouts
calibration and validation records
quality control and quality assurance records
licensing and registration records
equipment maintenance records
personnel records

Policy and procedure manuals

SOP for developing documents
SOPs for all laboratory procedures
SOPs for equipment and method validation
SOPs for documents and records control
SOPs for specimen collection, storage and transport
policies for housekeeping
policies for inventory control and procurement
policies on evaluating referral laboratories
policies on conflict of interests
policies for communicating results, including maintaining confidentiality
policies on resolution of complaints and feedback from clinicians, patients and
other parties
policies on evaluating referral laboratories
policies on conflict of interest

Quality Policy Manual for Medical Laboratory Services in Kenya / 45

 laboratory safety manual
laboratory quality manual

10.4.2 Controlling laboratory quality documents

All the documents listed in section 10.4.1 shall be uniquely identified to include:
o title
o document identification number
o date of release
o version number
o revision date
o number of pages
o name and signature of author/publisher
o name and signature of reviewer
o name and signature of person authorizing distribution
All SOPs shall be reviewed at least every 2 years and any changes documented and
communicated to staff immediately.
All policies and SOPs shall be easily available and accessible to relevant staff.
Testing SOPs shall be readily available in hard copy at each bench where the testing
is performed.
A current and well-understood laboratory quality manual shall be available and
accessible to all laboratory staff. The quality manual shall summarize policies
(processes and procedures) for all areas of laboratory services and shall address all
the quality system elements.
A current and up-to-date laboratory safety manual shall be available and accessible
to all laboratory staff. This manual shall address precautions with respect to
specimens, laboratory waste management, personal protective equipment,
vaccination, post-exposure prophylaxis, chemical, biohazard, equipment, fire and
electrical safety precautions.
All procedures, SOPs, policies and manuals shall be dated and signed when put
into use.
Discontinued or obsolete documents shall be clearly marked and removed from all
points of use and filed to prevent their inadvertent use.
Test results shall be archived according to the laboratory archiving SOP and securely
maintained to prevent damage and unauthorized access, and retrieved as needed.

10.4.3 Long-term maintenance and retention of laboratory documents and

records
If documents and records are maintained in electronic form they shall be backed up on CD-
ROM or other media. In this format, the laboratory manager/director shall be responsible
for ensuring that the electronic document system is adequately communicated to and
understood by all relevant personnel so they can properly access and benefit from the
documents. Following is a guide on retention of laboratory documents:

46 / Quality Policy Manual for Medical Laboratory Services in Kenya

Request forms: laboratory request forms shall be kept until the authorized report on
investigations has been received by the person requesting the test.
Laboratory registers and other records of specimens received by a laboratory: 5 years.
Protocols of standard operating procedures: both current and outdated protocols shall be dated
and kept for at least 5 years on file
Appendix 1 provides guidelines on the retention periods for various documents.

Bibliography
Berte, Lucia M. Clinical laboratory technical procedure manuals; approved guideline, 5th ed.
GP02-A5. Clinical and Laboratory Standards Institute, National Committee for Clinical
Laboratory Standards, 2006. ISBN1562-386-00X.
International Organization for Standardization (ISO). Medical laboratoriesparticular
requirements for quality and competence. ISO 15189: 2007, 2nd ed.
International Organization for Standardization (ISO). ISO/IEC Guide 17025: 2005.
General requirements for competence of calibration and testing laboratories.
Kenya. Ministry of Medical Services. National strategic plan 20052010. Nairobi: Medical
Laboratory Services, 2008.
National Committee for Clinical Laboratory Standards (NCCLS). A quality system
model for healthcare; approved guidelines. GP26-A, vol. 19 no. 20. 1999.

Key messages

Laboratory quality documents and records must be maintained and controlled

in a retrievable and legible manner.
All controlled laboratory documents and records must be uniquely identified.
Laboratory documents and records maintained on a long-term basis shall be kept
in electronic format with appropriate backup, or in paper format in a fireproof,
waterproof and secure environment.

Quality Policy Manual for Medical Laboratory Services in Kenya / 47

CHAPTER 11: LABORATORY INFORMATION
MANAGEMENT SYSTEM

11.1 Purpose
The laboratory information management system (LIMS) serves to store and archive
essential laboratory data and information for immediate use and for later reference, in an
appropriate medium. This system shall ensure proper data management in data security,
integrity, confidentiality, long-term storage and archiving. This system may be in hard or
soft copy.

11.2 Policy
The laboratory manager/director shall establish an information management system
to provide regular and accurate data for planning, evaluating and improving quality
medical laboratory services.

11.3 Responsibilities

11.3.1 Laboratory manager/director

Ensures sufficient and secure data storage and archiving facilities
Establishes criteria for proper receipt and handling of information
Manages requests for patient information data
Ensures good laboratory documentation practice is maintained for paper-based
LIMS

11.3.2 Quality manager

Provides standardized data collection tools such as those listed in section 11.4.2.
Validates the LIMS to ensure it is appropriate for the purpose.
Verifies stored information to ensure correctness.
Ensures adherence to record archiving SOP.

11.3.3 Laboratory technical staff

Adhere to the guidelines provided for handling laboratory documents including
archiving.
Use up-to-date data collection tools.
Archive laboratory records according to the guidelines provided by the quality
manager.
Maintain confidentiality while handling patient information.

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11.3.4 IT personnel
Provide support for computer hardware, software and LIMS.
Ensure functionality and security of computer systems.
Provide back-up for data.

11.4 Procedure and processes

11.4.1 Use of LIMS

The LIMS shall be used for the following purposes:
collecting useful and appropriate information
preliminary analysis and use of results at every level
periodic reporting (monthly, quarterly)
analysis and use of information at higher levels
providing feedback to the originating facility
archiving and retrieving information and data

11.4.2 Data collection tools

Laboratory facilities shall be provided with standardized data collection tools. These
tools shall be reviewed and updated as required and shall include:
laboratory specimen and results registers or logbooks
quarterly and monthly reporting forms that include:
o state of equipment and supplies
o personnel
o summary of tests conducted
o summary of tests referred
o summary of quality assurance reports
o information from disease control programmes, for example DLTLD,
NASCOP
equipment and supplies inventory registers
staff inventory register
quality assurance record forms, registers and charts
referral forms and documents

11.4.3 Laboratory information management

The laboratory shall ensure that test results are legible, technically verified and
confirmed against patient identity.
The laboratory shall report test results clearly, indicating turn-around time, method,
and individual staff testing the sample, and if the testing is urgent.
The laboratory shall report test results using internationally recognized terminology,
nomenclature, and units.

Quality Policy Manual for Medical Laboratory Services in Kenya / 49

 All testing personnel shall be identified on the requisition and report form.
All test results shall be recorded in a logbook, register or electronic record in a
timely manner, according to agreed turn-around times.
To ensure the ability to trace laboratory reports to particular specimens, patients,
dates, testing method and staff performing the test, the laboratory shall:
o review reports and records for transcriptional, calculation or clerical errors
before archiving, using either paper- or media-based storage systems
o properly label reports and store in a secure location accessible only to
authorized personnel
o use the regulation or guidance (Appendix 1) on retention period of reports
o use back-up storage procedures (off-site storage, duplicate CD or other
media) to prevent the loss of test result data in the event of hardware or
software failure or theft
o refer to ISO 15189: 2007(E) Annex B: Recommendations for protection of
a laboratory information system for details of safeguarding integrity of
laboratory data

Background information
Berte, Lucia M. Clinical laboratory technical procedure manuals: approved guideline, 5th ed.
GP02-A5. Clinical and Laboratory Standards Institute, National Committee for Clinical
Laboratory Standards, 2006. ISBN1562-386-00X.
International Organization for Standardization (ISO). Medical laboratoriesparticular
requirements for quality and competence. ISO 15189: 2007, 2nd ed.
International Organization for Standardization (ISO). ISO/IEC Guide 17025: 2005.
General requirements for competence of calibration and testing laboratories.
Kenya. Medical Laboratory Services. National strategic plan 20052010. 2008, Ministry of
Medical Services
National Committee for Clinical Laboratory Standards (NCCLS). A quality system
model for healthcare; approved guidelines. GP26-A, vol. 19 no. 20. 1999.
World Health Organization. Quality systems for medical laboratories. WHO Guidelines for
Implementation and Monitoring. WHO Regional Publications, Eastern Mediterranean
Series 14, 1995.

Key messages

The laboratory must have standardized data collection tools.

LIMS may either be computer or paper based and is used to store and retrieve
laboratory data and information.
Laboratories must report test results using internationally recognized
terminology, nomenclature and units.

50 / Quality Policy Manual for Medical Laboratory Services in Kenya

CHAPTER 12: LABORATORY COMMUNICATION
MANAGEMENT

12.1 Purpose
Laboratory communication management ensures effective flow of information within and
outside the laboratory, while remaining mindful of the confidentiality of information as
stipulated by legal and regulatory requirements.

12.2 Policy
The laboratory manager/director shall establish appropriate and effective communication
systems for both internal and external communication. All communication shall
be documented, filed and archived as required by the quality management system
programme.

12.3 Responsibilities
The laboratory manager/director is responsible for overall external and internal
communication.
The quality manager is responsible for communication relating to the quality
management system.
All laboratory staff members are responsible for acknowledging and complying
with communication messages and directives.

12.4 Procedure and processes

12.4.1 Classification of laboratory communication

Internal communication refers to communication within the laboratory.
External communication refers to communication and interaction with other health
professionals, patients, referral laboratories, suppliers, regulatory authorities and
other parties.

Internal communication
The laboratory manager/director is responsible for establishing appropriate and effective
communication channels within the laboratory. Internal communication may be managed
through, but is not be limited to:
general meetings
management meetings
technical meetings
quality meetings
memos on notice boards
e-mail

Quality Policy Manual for Medical Laboratory Services in Kenya / 51

The quality manager shall establish monthly quality meetings and document the minutes
of these meetings. The frequency of other meetings shall be decided upon by the laboratory
manager/director.

External communication
The laboratory manager/director is responsible for external communication and may
designate a responsible person to perform this task. However, it is the responsibility of
the laboratory manager/director to ensure that all communication is appropriate and
consistent with the laboratorys quality policy.

12.4.2 Interactions with other professionals

The laboratory manager/director shall establish regular meetings or seminars
with other health professionals to discuss and disseminate quality, scientific and
technical laboratory issues.
The laboratory manager/director shall be a member of relevant health facility
committees and be invited to join in facility meetings where laboratory services are
discussed.
Various issues may be discussed at these meetings including testing services, choice
of testing, types of samples, test requests, result reporting, turn-around times, and
general service issues.
When the laboratory receives calls, visits, questions or information requests from
health care professionals they shall ensure that the response is:
o always respectful and considerate of the knowledge and experience of the
other health care professionals
o communicative and cooperative to the full extent necessary to serve the best
interests of the patient
o clearly communicated to maintain the relationship, with due regard to
privacy and confidentiality
o documented, with all details of each communication, including name of
contact person, date, time and content of the communication, for example,
questions asked, responses given, action taken

Supporting documents
primary sample collection manual
procedure for reporting (including interim and telephone reports)
procedure for customer complaint resolution
procedure for review of contracts
customer satisfaction survey

12.4.3 Interaction with patients

There are various processes during which the laboratory may interact with patients such as
sample collection, receiving calls or complaints regarding laboratory services, or questions
regarding a test result. Laboratory staff who interact with patients shall:

52 / Quality Policy Manual for Medical Laboratory Services in Kenya

 always treat patients and their families with respect and dignity
obtain patient information that is relevant to the testing only
verify the patients identity by asking the patient to say their name before collecting
the sample
provide a clear explanation to the patient about what is going to happen
always wear personal protective equipment when collecting samples
follow written procedures (SOPs) for sample collection
Laboratory staff who receive a call or complaint from a patient shall:
communicate and cooperate to the full extent necessary to serve the best interests
of the patient
document all details of the call or complaint including the patients name, date and
time; content of the communication, for example, questions asked and responses
given; and any action taken
notify the laboratory manager/director of the call or complaint immediately after
the call or complaint is made, and of any action taken
The laboratory manager/director or quality manager shall monitor if the complaint has
been adequately resolved.

Supporting documents
primary sample collection manual
procedure for reporting
procedure for customer complaint resolution
customer satisfaction survey

12.4.4 Interaction with suppliers

Interactions between laboratory staff and suppliers may include:
communication during laboratory supplies or equipment procurement
call for reagents
technical support on products and equipment
equipment maintenance services
When laboratory staff interact with suppliers, it is important to ensure that communications
are clear and well documented.

Supporting documents
procedure for supplies management
procedure for equipment management

Quality Policy Manual for Medical Laboratory Services in Kenya / 53

Background information
International Organization for Standardization (ISO). Medical laboratoriesparticular
requirements for quality and competence. ISO 15189: 2007, 2nd ed. Annex B.4 Systems
security, Annex B.5 Data entry and reports, Annex C.3 Information, Annex C.4 Consent,
Annex C.9 Other purposes.

Key messages

Laboratory information is sensitive and must be communicated appropriately

and carefully.
When communicating to patients, laboratory staff must show respect and dignity,
and ensure clear explanations are given.
Laboratory communications with external partners, especially vendors, must be
structured and well documented.

54 / Quality Policy Manual for Medical Laboratory Services in Kenya

APPENDIX 1. DOCUMENT RETENTION GUIDELINES

Document Minimum retention period

General laboratory
Accession log 2 years or between full assessments, whichever is
longer
Instrument records including maintenance records, Lifetime of the instrument or a minimum of 10 years
printouts, calibration and verification records after equipment disposal
Quality control records including performance data, 2 years or between full assessments whichever is
instrument printouts, and corrective action longer
Proficiency testing results including corrective actions Subscribing laboratories or individuals: a minimum
of 5 years. Records shall be maintained for longer
periods by external quality assurance providers
Management review documentation 2 years or between full assessments, whichever is
longer
Reports of internal audits 2 years or between full assessments, whichever is
longer
Corrective action reports 2 years or between full assessments, whichever is
longer
2 years or between full assessments whichever is
Preventative action reports
longer
Quality assurance records and QA meeting minutes 2 years or between full assessments, whichever is
longer
Records of employee signatures, initials, and
10 years
identification codes
Working records of laboratory test results 5 years
Records of telephoned reports 2 years
Validation and verification records results 5 years
Accreditation documents; records of inspections 10 years or until superseded
Surgical pathology (including bone marrow)
Wet tissue 2 weeks after final report
Paraffin blocks 10 years
Slides 10 years
Reports 10 years
Cytology (gynaecological)
Slides (negativeunsatisfactory) 5 years
Slides (suspiciouspositive) 5 years
Quality assurance studies 5 years
Reports 10 years
Cytology (non-gynaecological)
Fine needle aspiration slides 10 years
Body fluid slides 10 years
Reports 10 years

Quality Policy Manual for Medical Laboratory Services in Kenya / 55

Quality assurance studies 10 years
Note: Cytology slides may be loaned to proficiency testing (PT) programmes in lieu of maintaining them for
the required time period, provided the laboratory receives written acknowledgement of the receipt of the
slides by the proficiency testing programme. Documentation of slides loaned or referred for purposes other
than PT testing must be maintained and all slides must be retrievable upon request.

Non-forensic autopsy
Wet tissue 3 months after final report
Paraffin blocks 10 years
Slides 10 years
Reports 10 years
Forensic autopsy
Wet stock tissue 1 year
Paraffin blocks Indefinitely
Reports Indefinitely
Slides Indefinitely
Gross photographs and negatives Indefinitely
Accession log Indefinitely
Body fluids and tissues for toxicology 1 year
Representative tissue suitable for DNA analysis Indefinitely
Clinical pathology
Patient test records 2 years
Urine 24 hours
Serum/CSF/body fluids (except urine) 48 hours
Peripheral blood films /body fluid smears 7 days
Permanently stained slidesmicrobiology (i.e. Gram 7 days
stains).
10 years
Reports
Cytogenetics
Permanently stained slides 3 years
Fluorchrome stained slides 3 years or longer at the discretion of the
laboratory director
Wet specimen, tissue Until adequate metaphase cells are obtained
Fixed cell pellet 2 weeks after final report
Final reports 20 years
Diagnostic images (digitized, prints or negatives) 20 years
Flow cytometry
Gated dot plots and histograms 10 years

56 / Quality Policy Manual for Medical Laboratory Services in Kenya

 Blood bank
Donor and recipient records 10 years
Patient records 10 years
Quality control records 5 years
Permanently deferred donors, or donors placed under Indefinitely
surveillance for the recipients protection (e.g. those
donors that are hepatitis B core positive once, donors
implicated in a hepatitis-positive recipient)
Specimens from and potential and confirmed recipients 7 days post-transfusion
Blood donor units 7 days post-transfusion

Background information
The American Association for Laboratory Accreditation. L:\Medical\ Requirements\R651
- General Requirements-Accreditation of Medical Testing Laboratories Meeting the ISO
15189

Quality Policy Manual for Medical Laboratory Services in Kenya / 57

Appendix 2: Documents Review and
Authorisation Signatures

Authorised approval
A) Review record:

___________________ ____________________ ________ _______________

Reviewed by Designation Date Signature

___________ ____________________ _________ ______________

Approved by Designation Date Signature

Next review date: _____________________

B) Issue record

_____________ _____________________ _________ ______________

Issued by Designation Date Signature

Issued to:
Facility name _________________________________________________

______________ _____________________ _________ ______________

Received by Designation Date Signature

Facility quality manager: _____________________ Signature___________________

58 / Quality Policy Manual for Medical Laboratory Services in Kenya

Appendix 3: Documents Training Record

The following Medical Laboratory Services of Kenya staff have read and understood this
Quality Policy Manual for Medical Laboratories in Kenya.
A copy of this page shall be placed in each employees training record file.

Name Signature Date

Quality Policy Manual for Medical Laboratory Services in Kenya / 59

Appendix 4: Contributors and Reviewers

John Matoke National Public Health Laboratory Services

Peter Kariuki Kenya Medical Training College
Raphael Gikera Association of Kenya Medical Laboratory Scientific Officers
Mike Mayabi National Public Health Laboratory Services
Ernest Makokha Centers for Disease Control and Prevention
Pamela Juma TB Central Reference Laboratory
Isaac Mugo African Medical and Research Foundation
Samuel Mbugua Management Sciences for Health
Josephat Wambua Aga Khan University Hospital
Jane Carter African Medical and Research Foundation
Rodgers Dena African Medical and Research Foundation
Jackson Songok African Medical and Research Foundation
Martin Matu African Medical and Research Foundation
Enock Marita African Medical and Research Foundation
Julius Tome African Medical and Research Foundation
Jackson Sinkeet African Medical and Research Foundation
Patience Wanyama African Medical and Research Foundation
Kevin Omondi Risk Accredition Management Systems

REVIEWERS

Expert reviewers
Clement Zeh Centers for Disease Control and Prevention, Kenya
Jane Mwangi Centers for Disease Control and Prevention, Kenya
Jane Carter African Medical and Research Foundation
Ephantus Njagi Supply Chain Management Systems

National MOH Reviewers

Willis Akhwale Department of Disease Prevention and Control
Jane Wasike National Public Health Laboratory Services
Moses Njue Department of Diagnostics and Forensic Services
Dorothy Njeru Department of Diagnostics and Forensic Services
Abdulatif Ali National Public Health Laboratory Services
John Matoke National Public Health Laboratory Services; National Quality
Assurance Laboratory
Alice Ngoni National Blood Transfusion Services
Purity Chacha National Public Health Laboratory Services; Human Resource

60 / Quality Policy Manual for Medical Laboratory Services in Kenya

Irene Machiro National Public Health Laboratory Services; National Public
Health Bacteriology Laboratory
Simion Kimani National Public Vaccine Laboratory
Nancy Njine National Public Health Laboratory Services ; National Public
Food Laboratory
Beth Njaramba National Public Health Laboratory Services ; Medical Engineering
Unit
Albert Bunyasi National Public Health Laboratory Services ; Biosafety and
Biosecurity Office
Mamo Umuro National Public Health Laboratory Services ; National HIV
Reference Laboratory
Stephen Kipkerich National Public Health Laboratory Services ; National HIV
Reference Laboratory
Samuel Ongwae National Blood Transfusion Services
Ephraim Adel National Central Tuberculosis Reference Laboratory

Regional reviewers
John Kimani Ngugi Ministry of Medical Services, Central Province
Samuel Ogweno Ministry of Medical Services, Nyanza Province
Daniel M Muriithi Ministry of Medical Services, Eastern Province
Joseph Kimaru Ministry of Public Health and Sanitation, Eastern Province
Beatrice Kimaru Ministry of Medical Services, Rift Valley Province
Esther Lemarkok Ministry of Public Health and Sanitation, Nairobi
Samuel Gichuhi Ministry of Medical Services, Rift Valley Province

Quality Policy Manual for Medical Laboratory Services in Kenya / 61

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Quality Policy Manual for Medical Laboratory Services in Kenya / 63
 This Quality Policy Manual was developed by the Ministry of Public
Health and Sanitation and the Ministry of Medical Services

In collaboration with

African Medical and Research Foundation (AMREF)

Management Sciences for Health, Strengthening (MSH)
United States Agency for International Development (USAID)
Centers for Diseseases Control and Prevention (CDC)