BCT Reports HLM-354
BCT Reports HLM-354
BCT Reports HLM-354
Distribution:General
Page 2
© World Health Organization (2003)
Page 4
PREFACE
WHO has been assiduously promoting quality of health care at all levels.
The health laboratories provide strategic support to both clinical and
public health services in providing quality services. In recent years,
excellent progress has been made in various fields of medicine. These
developments have revolutionized health laboratory services. The latest
molecular tools have greatly enhanced the accuracy of various test
procedures. However, this unparalleled progress in the field of diagnostic
medicine can benefit humanity only if the laboratory services are
accessible to users and the results produced by the laboratories are
reliable, reproducible and rapid enough to be useful.
An optimal utilization of health laboratories is possible only when
laboratory services are planned meticulously and resources invested
judiciously into this area. To achieve this basic prerequisite of the
planning process, WHO has been creating a database of the status of
health laboratories in the Member Countries of the South-East Asia
Region. This information is based on the observations made by large
number of international experts during their recent visits to Member
Countries.
In many countries of our Region, health laboratories have not been
able to contribute optimally because of various reasons, notably: lack of
clearly-defined national policies for laboratory services; shortage of
trained manpower; poor linkages and communication; obsolescence of
health facilities; shortage and inappropriate laboratory equipment; non-
availability and hence non-utilization of standard operating procedure
manuals in laboratory techniques; poor development of internal quality
control methods, and inadequate number of laboratories participating in
external quality assessment schemes.
Page iii
This document is aimed to provide an independent status of health
laboratories in Member Countries of South-East Asia Region to the health
administrators to support them in developing effective plans for
strengthening and utilization of laboratory services.
Dr Sudarshan Kumari
Regional Adviser
Page iv
ACKNOWLEDGEMENT
Page iv
ABBREVIATIONS
ABBREVIATIONS AND ACRONYMS
Page v
NICD National Institute of Communicable Diseases, Delhi, India
QA Quality Assurance
Page vi
CONTENTS
Page
1. INTRODUCTION ...................................................................................1
Page vii
8. ACTION PLAN FOR STRENGTHENING OF QUALITY ASSURANCE............34
Annexes
Page viii
1. INTRODUCTION
Quality assurance (QA) in health laboratories incorporates all the
factors that may influence the generation of reliable results. It
comprises two key components. Internal quality control (IQC)
includes appropriate measures taken during day-to-day activities
to control all possible variables that can influence the outcome of
laboratory results. This is a continuous process that operated
concurrently with analysis. External quality assessment scheme
(EQAS) is the other component. This component is necessary to
ensure comparability of results among laboratories. This
component is carried out retrospectively and is conducted by an
independent agency.
Page 1
Quality Assurance in Health Laboratory Services: A Status Report
Page 2
Quality Assurance in Health Laboratory Services: A Status Report
2. SUBJECT-
SUBJECT- SPECIFIC LABORATORY NETWORKS
Page 3
Quality Assurance in Health Laboratory Services: A Status Report
Page 4
Quality Assurance in Health Laboratory Services: A Status Report
2.3 Tuber
Tuberculosis
With the upsurge in multidrug resistant tuberculosis in the
countries of the world, especially in association with AIDS, WHO is
conducting an international IEQAS for MDR tuberculosis.
Page 5
Quality Assurance in Health Laboratory Services: A Status Report
Page 6
Quality Assurance in Health Laboratory Services: A Status Report
Page 7
Quality Assurance in Health Laboratory Services: A Status Report
4. COUNTRY-
COUNTRY-WISE S
SITUATION
ITUATION OF LABORATORIES
LABORATORIES IN
SEA REGION
The country-wise situation of laboratories in the South-East Asia
Region is given in detail in Annex 2.
4.1 Bangladesh
Health laboratory services structure consists of public sector
laboratories under the various ministries, autonomous medical
university (Bangabandhu Sheikh Mujib Medical University), semi-
government hospital laboratories, nongovernmental organizations
(e.g. BIRDEM) and private laboratories.
Page 8
Quality Assurance in Health Laboratory Services: A Status Report
Page 9
Quality Assurance in Health Laboratory Services: A Status Report
the country. Tests for blood-borne infections i.e, HIV, HBsAg, HCV,
malaria and syphilis are being conducted. It will also conduct EQAS
for blood serology and serology of transfusion-borne infections.
4.2 Bhutan
Page 10
Quality Assurance in Health Laboratory Services: A Status Report
Page 11
Quality Assurance in Health Laboratory Services: A Status Report
Type of Laboratories
Anti-
Anti-epidemic University/Hospital
Central 1 6
Provincial 12 36
Page 12
Quality Assurance in Health Laboratory Services: A Status Report
Page 13
Quality Assurance in Health Laboratory Services: A Status Report
4.4 India
In India, there is no national policy for EQAS as yet, but a
programme of networking of laboratories for surveillance of
communicable diseases has been drawn up with the help of WHO
and has been submitted to Government of India. It includes
provision of QA as an ongoing activity involving all laboratories in
India. Accreditation of laboratories on voluntary demand has been
started, but these are mainly private laboratories. It is hoped that
the national policy for QA, when initiated and implemented, will
encompass accreditation of all the laboratories in the network.
Page 14
Quality Assurance in Health Laboratory Services: A Status Report
4.5 Indonesia
The Directorate for Health Laboratories (Direktorat Laboratorium
Kesehetan – Dit Lab Kes) is the supreme controlling authority in
Indonesia. It controls the public health laboratories in the 26
provinces of Indonesia and is responsible for their functioning and
carrying out activities for public health in the respective provinces.
In coordination with the appropriate directorates in the Ministry of
Health, it also controls the pathology laboratories in the Ministry of
Health, Government hospitals, and peripheral health laboratories.
With this mandate, it has been carrying out external quality
assessment in various disciplines of laboratory medicine.
WHO has been closely associated with this activity since its
inception. In 1989 a workshop was held in Yogyakarta for the
initiation of EQAS in clinical microbiology. Under the WHO/UNDP
project, another workshop was held in 1992 in EQAS for laboratory
medicine, clinical chemistry and clinical microbiology.
Page 15
Quality Assurance in Health Laboratory Services: A Status Report
4.6 Maldives
There are twenty three (23) health laboratories in the Maldives. Of
these, fourteen are situated in the island of Male’ and nine outside.
Of the fourteen laboratories in Male’, there are three large
laboratories, namely, the Indira Gandhi Memorial Hospital (IGMH)
laboratory, which is the main laboratory in the country concerned
with patient care, the Public Health Laboratory (PHL), dealing with
food, water and sanitation aspects and the “ADK” laboratory, a
large private laboratory. Additionally, there are three medium-
sized and eight small laboratories.
Page 16
Quality Assurance in Health Laboratory Services: A Status Report
Apart from the staff of IGMH and PHL, the laboratory staff in
the other establishments have very little knowledge of the concept
of quality assurance. The ADK hospital laboratory, the private
medical laboratory is well equipped and the staff is aware of the
concept of quality assurance.
Regional hospitals
(1) Addu regional hospital laboratory
(2) Kulhudhuffushi regional hospital laboratory
(3) Ugoogaaru regional hospital laboratory
(4) Mulee regional hospital laboratory
(5) Thnadhoo regional hospital laboratory
(6) Eydhafulah atoll hospital laboratory
(7) Fuahmulah atoll hospital laboratory
(8) Naifaru atoll hospital laboratory
(9) Laamu atoll hospital laboratory
Page 17
Quality Assurance in Health Laboratory Services: A Status Report
4.7 Myanmar
Administratively, the country is divided into 17 states and divisions
with 52 districts, 324 townships (rural and urban). The population
of the country is 50 million with more than 75 % population
residing in the rural areas.
Page 18
Quality Assurance in Health Laboratory Services: A Status Report
Page 19
Quality Assurance in Health Laboratory Services: A Status Report
Scheme was held from 11-13 May, 1998, and a training course for
Key Trainers in Quality Assurance from 11-13 September 2000.
4.8 Nepal
Nepal has a network of 185 health laboratories in the Government
sector that are scattered in various geographical regions of the
country.
Page 20
Quality Assurance in Health Laboratory Services: A Status Report
Regional laboratories 2
District level 73
(9 zonal, 64
district)
Page 21
Quality Assurance in Health Laboratory Services: A Status Report
District laboratories 38
4.10 Thailand
Page 22
Quality Assurance in Health Laboratory Services: A Status Report
EQAS
This service is provided to laboratories of both public and private
sectors throughout the country, especially those of clinical
laboratories covering the areas of clinical chemistry, clinical
microscopy, clinical microbiology, haematology, clinical
immunology, and blood banking. Altogether, there are now 600
health stations joining this programme, which is 20 years old.
Page 23
Quality Assurance in Health Laboratory Services: A Status Report
5. INFRASTRUCTURE AS RELATED
RELATED TO DIFFERENT
LEVELS OF LABORATORIES
LABORATORIES
The details of infrastructure available at different levels of
laboratories are provided in Table 1. Broadly, the human resource,
equipment, quality control measures, documentation, technical
expertise and infrastructure available in the central laboratories
and medical colleges laboratories conform to international
requirements, rules and regulations. Infrastructure is weak at the
peripheral laboratories. Adequate human resource is available only
in some peripheral laboratories and their continuous training and
upgradation of skills are rarely undertaken. These laboratories
document most of their activities and results, but are deficient in
internal quality control, availability and maintenance of equipment
as well as quality reagents, kits, antisera and other chemicals.
Page 24
Quality Assurance in Health Laboratory Services: A Status Report
Table 1
Status of IQC parameters-
parameters-
STATUS OF QUALITY ASSURANCE ACTIVITIES IN SEAR COUNTRIES
Page 25
Quality Assurance in Health Laboratory Services: A Status Report
Central level
Adequacy of staff
Professional Yes Yes Yes Yes Yes
Supportive Yes Yes Yes Yes Yes
Training of staff Yes Yes Yes Yes Yes
Availability and use of SOP Yes/WHO Yes/WHO Yes /WHO Yes/Own Yes/WHO
Equipment maintenance Yes Yes Yes Yes Yes
Documentation Good Good Good Good Good
Internal quality assessment Yes Yes No Yes Yes
Internal audits Rarely Rarely No Yes Rarely
Medical College
labs/Regional/Provincial
Adequacy of staff
Professional Yes Yes Yes Yes Yes
Supportive Yes Yes Yes Yes Yes
Training of staff Yes Yes Yes Yes Yes
Availability and use of SOP Yes/WHO Yes/WHO Yes/WHO Yes /Own Yes /WHO
Equipment maintenance Yes Yes Yes Yes Yes
Documentation Good Good Good Good Good
Internal quality assessment Yes Yes No Yes Yes
Internal audits Rarely Rarely No Yes Rarely
District level
Adequacy of staff
Professional Yes Yes Yes Yes Yes
Supportive Yes Yes Yes Yes Yes
Training of staff Yes Yes Yes Yes Yes
Availability and use of SOP No Yes/WHO No Yes/Own Yes /WHO
Equipment maintenance Yes Yes Rarely Yes Yes
Documentation Good Good Good Good Good
Internal quality assessment No No No Yes Yes
Internal audits Rarely Rarely No Rarely Rarely
Peripheral level
Page 26
Quality Assurance in Health Laboratory Services: A Status Report
Adequacy of staff
Professional No No No No Yes
Supportive Yes Yes Yes Yes Yes
Training of staff Rare Rare Rarely Yes Yes
Availability and use of SOP No No No Yes /Own Yes /WHO
Equipment maintenance Rarely Rarely Rarely Yes Yes
Documentation Good Good Good Good Good
Internal Quality assessment No Rarely No No Yes
Internal audits Rarely Rarely No Rarely Rarely
Page 27
Quality Assurance in Health Laboratory Services: A Status Report
Page 28
Quality Assurance in Health Laboratory Services: A Status Report
Page 29
Page 30
Participation in IEQAS Not since No No- Yes Yes No No No Yes since Yes
6 1999 Belgium Belgium 1988 Australia
Accreditation - - - - -
Page 31
Quality Assurance in Health Laboratory Services: A Status Report
7. CONSTRAINTS IN ENSUR
ENSURING
ING STANDARDS IN
HEALTH LABORATORIES
Several constraints were identified in ensuring quality standards in
health laboratories. These include:
Page 32
Quality Assurance in Health Laboratory Services: A Status Report
Page 33
Quality Assurance in Health Laboratory Services: A Status Report
Management
! Policy and commitment for quality
Page 34
Quality Assurance in Health Laboratory Services: A Status Report
! Planning
! Allocation of appropriate resources
! Provision of suitable infrastructure, material, manpower
! Networking between laboratories
! Biosafety
! Errors management
! Participation in EQAS, accreditation
Standards
! National
! International
Training
! Induction training
! In-service training to upgrade the skills in specific areas
Documentation
! Quality Manual
! SOP
! Worksheets
! Records
Monitoring, evaluation
! Use of statistical process tools
! Internal assessment
! Internal audit
Page 35
Quality Assurance in Health Laboratory Services: A Status Report
Page 36
Quality Assurance in Health Laboratory Services: A Status Report
Process of EQAS
Page 37
Quality Assurance in Health Laboratory Services: A Status Report
Analysis of results
Reporting results
Preparation of report
Evaluation
Page 38
Quality Assurance in Health Laboratory Services: A Status Report
Ann
Annex 1
STATUS OF QUALITY AS
ASSURANCE
SURANCE ACTIVITIES IIN
N SEAR COUNTRIES
Parameter for
quality assurance DPR
BHU BAN INO IND MAV MMR NEP SRL THA
of diagnostic K
laboratories
1. National policy
and guidelines
for quality
- - - - - - - - - +
assurance of
diagnostic
laboratories
2. National policy
on accreditation
- - - - + - - - - +
of diagnostic
laboratories
3. National
regulatory
authority
- - + + + - - - - +
assuring quality
of diagnostic
laboratories
4. Networking of
diagnostic - - - + - - - - - +
laboratories
5. National
Regulatory
- - - - - - - - - +
Laboratory for
diagnostic kits
6. Availability of - - - +@ +@ - +@ - - +
SOPs for IQC &
Page 39
Quality Assurance in Health Laboratory Services: A Status Report
EQAS
7. Networking of
laboratories for - - - - - - - - - +
quality assurance
8. Organization of
- - - + +* - + - +* +
NEQAS
Page 40
Quality Assurance in Health Laboratory Services: A Status Report
Annex 2
Parameter for
quality
assurance of BHU BAN DPRK IND
IND INO
INO MAV MMR NEP SRL THA
diagnostic
laboratories
1. Number of
laboratories in
public sector
Central level 1 1 1 1 1 2 1 1 1 1
Medical college
laboratories/ 180+
13 2 26 9 38 6+2 20 12
Regional/ 31
Provincial
2. Number of
laboratories in 2000 Nil Nil N.A N.A N.A N.A N.A
private sector
Page 41
Quality Assurance in Health Laboratory Services: A Status Report
Laboratories in
metropolitan 400 8 4
cities
Laboratories in
N.A N.A
Districts
Laboratories in
N.A N.A
villages
NA – Not Available
Page 42
Page 43