Accreditation of Laboratory Services

Introduction

In any market competition increases quality and improves consumer welfare when prices are
regulated for prices above marginal cost, although the impacts on social welfare are
ambiguous. When firms set both price and quality, both the positive and normative impacts of
competition are ambiguous (Gaynor 2006). Provision of healthcare today is a huge market.
Although the complete market is not observed in healthcare, market mechanisms can be
observed in to a considerable extent. The effective operation of markets needs buyers and
sellers to be confident in the reliability and competence of their (trading) partners and in the
information, they provide on the properties of goods and services offered. There are a variety
of ways in which market agents can develop the knowledge and confidence in goods and
services. These included repeated purchases from one or several suppliers, to test suitability
of the good or service and the reliability of the supplier. This is of course costly especially for
high value, infrequently purchased or safety critical items. Buyers can instead depend on the
reputation of suppliers as a signal of quality and confidence.

An alternative source of confidence in the capabilities of suppliers of such critical goods and
services is the implementation of standards for performance and the evolution of conformity
assessment as a way of ensuring that the suppliers proceed consistently with the standard and
so can be relied on. Accreditation reinforces conformity assessment by providing an external
badge of competence for the assessment bodies. Accreditation is the external validation of
organizations offering conformity assessment services such as calibration, testing, inspection
and certification. When products, services, processes or organizations are evaluated by a
third-party conformity assessment body, accreditation offers an additional, top-layer quality
assurance by assessing the competence and impartiality of the conformity assessment bodies.
This is done by accrediting the organizations offering conformity assessment to a recognized
standard (Frenz and Lambert 2013).

It is usually performed by a multidisciplinary team of health professionals and is assessed

against published standards for the environment in which health care service is delivered
(World Health Organization 2003).
Accreditation

Efficient and reliable laboratory services and networks are essential and fundamental
components of effective, well-functioning health systems. High-quality laboratory testing is
critical for patient care, prevention, disease surveillance, and outbreak investigations
(Gershy-Damet et al. 2010).

Concerns on quality of products and services made the organizations to compliance with
technical regulations, standards and other regulatory measures. These measures have a focus
on health and safety other than the quality. While the regulation by authorities focus on the
public interests and benefits, the standards by relevant sector focus more on market and
competition.

Historical quality assurance programs do not appear to be significantly improving the total
testing process. Manufacturing and service industries are using quality systems strategies,
such as ISO 9000 and the Baldridge Award Criteria, to effect improvements in both
productivity and cost. Quality system solutions for performance improvement may provide a
systematic approach to improving laboratory performance.

Accreditation is emerging as a preferred framework for building quality medical laboratory

systems in resource-limited settings. Despite the low numbers of laboratories accredited to
date, accreditation has the potential to improve the quality of health care for patients through
the reduction of testing errors and attendant decreases in inappropriate treatment. Accredited
laboratories can become more accountable and less dependent on external support. Efforts
made to achieve accreditation may also lead to improvements in the management of
laboratory networks by focusing attention on areas of greatest need and accelerating
improvement in areas such as supply chain, training, and instrument maintenance. Laboratory
accreditation may also have a positive influence on performance in other areas of health care
systems by allowing laboratories to demonstrate high standards of service delivery.
Accreditation may, thus, provide an effective mechanism for health system improvement
yielding long-term benefits in the quality, cost-effectiveness, and sustainability of public
health programs(Peter et al. 2010).

There are number of factors on which the technical competency including,

 Qualifications, training and experience of the staff

 Correct equipment – properly calibrated and maintained

  Adequate quality assurance procedures

 Proper sampling practices

 Appropriate and valid testing procedures and methods

 Traceability of measurements to national standards

 Accurate recording and reporting procedures

 Suitable testing facilities

Benefits of Accreditation

Accreditation is beneficial for healthcare regulators, for patients and for medical laboratories
as well. Healthcare Regulators need to ensure the quality of care for patients, not forgetting
efficiency and productivity. Accreditation is helpful to regulators to make sure:

 providing an independent assurance of quality and safety that supports world-class

decisions on how to deliver better care and value for patients
 providing a mechanism for measuring quality improvement
 supporting consistency in the quality of care
 encouraging innovation

Patients are benefited by accreditation in following ways.

 there is consistency in the quality of care

 the service has up-to-date-technologies and its procedures and techniques reflect
current best practice
 staff providing the service are competent to undertake the tasks they perform

Accreditation for medical laboratories:

 provides an opportunity for external perspectives on the laboratory’s practice

 can prevent the unnecessary duplication of information gathering on performance
often required by regulatory bodies
 encourages the sharing of best practice
  stimulates innovation
 reduces risk
 provides international recognition

Medical Laboratory Accreditation- world scenario

Medical laboratories can seek recognition as being compliant with particular standards
through a number of different systems. Recognition of medical laboratories handling clinical
specimens as distinct from those dealing with the results of pre-clinical studies are in their
infancy in most European countries. A laboratory accreditation system contains three
elements, the organization or authority which conducts the inspections or assessments and
grants accreditation (and may also set the standards), the inspection or assessment which
seeks to establish compliance with the standards, and crucial to the whole process the
standards themselves.

In most European countries the emphasis has been on development of standards and quality
manuals and practical experience in all three elements of accreditation is, with a few
exceptions, is very limited. In other parts of the world, such as USA, Canada and Australia
there is depth of experience from which other countries can learn. Accreditation systems in
different parts of the world have developed in different ways but almost always with the
active involvement of laboratory professionals. In Europe different countries have one, or
occasionally more, National bodies mandated by government to accredit laboratories
according to EN 45001:1989, ‘General criteria for the operation of testing laboratories’-
ISO/IEC Guide 25 or to accredit certifying bodies who perform third party assessments to
ISO 9000 quality systems standards. These bodies for example SWEDAC in Sweden, RvA in
The Netherlands and UKAS in the UK are members of the European Co-operation for
Accreditation (EA). National members of EA conduct themselves in accordance to the
ISO/IEC Guide 58:1993 ‘Calibration and testing laboratory accreditation systems - General
requirements for operation and recognition’. An EA Committee in the Health Care Sector has
been formed encompassing a sub group on laboratory accreditation. The membership of this
subgroup is not limited to official National bodies (3-4) but includes 3 members from
accrediting bodies such as Clinical Pathology Accreditation (UK)Ltd from the United
Kingdom and CCKLTest from The Netherlands who work closely with their respective
official National bodies.
UKAS has recently signed a ‘Declaration of Intent to Cooperate’ with CPA(UK)Ltd) and
RvA has trained inspectors together with CCKLTest for several years. In addition, there are
on the subcommittee, 6 members from the pathology professions and one member from the
European Diagnostics Manufacturers Association (EDMA).

Now there are a multiplicity of draft international standards; ISO 9001:2000 - ‘Quality
management systems - requirements’, ISO/IEC DIS 17025 ‘General requirements for the
competence of testing and calibration laboratories’ (Revision of EN45001:1989-ISO/IEC
Guide 25) and ISO/CD 15189 ‘Quality Management in the medical laboratory’, which could
be used by medical laboratories to signify compliance with standards of excellence. An
understanding of the evolutionary history of these standards and the work of other groups
such as the European Communities Confederation of Clinical Chemistry (EC4) is important
in trying to understand the convergence of the certification and accreditation approaches to
the recognition of a quality laboratory service. In recent years however, the National Council
for Clinical Laboratory Standards (NCCLS) have held the Secretariat for ISO/TC 212/ WG1
which is responsible for the emerging ISO/CD 15189, the first international standard
specifically for quality management in medical laboratories. It is important that standards
should be written clearly, be practicable and credible and verifiable on inspection and
preferably be generic in form, that is applicable to all disciplines or situations. International
standards should be written in accordance with ISO Directive, ISO/IEC Directives, Part
3:1997, Rules for the structure and drafting of individual documents and can have many
distinct intentions. Three of the most important are (a) to specify a product, material process
or system (requirements), (b) to give recommendations (guidelines) and (c) to clarify
concepts and/or classify terms and vocabulary (concepts and vocabulary). Requirements are
written using the auxiliary verb, ‘shall’ and recommendations using ‘should’. Standards
which are written as guidelines are often explanatory to a parallel generic standard of
requirements. It is the task of the accreditation organizations or authorities to conduct the
inspections or assessments and grant accreditation. It is vital that these inspections are done
in an objective manner as possible. The frequency and length of inspections varies in
different countries as does the nature, content and length of the training of inspectors. Some
countries use full time inspectors but generally inspectors are practicing laboratory
professionals and the practicalities of maintaining an inspection frequency of less than once
every four years are very real. It is proposed that, an intermediate reporting mechanism
perhaps through the laboratory submitting an internal ‘management review’ report annually
to the accrediting organization, would mitigate these difficulties.

In Europe, the EA Health Care Sector sub group on laboratory accreditation has a major role
to play in seeking a harmonized approach to the assessment process and to standard setting
whilst respecting the European Community principle of subsidiarity. In Europe as in other
parts of world groupings of countries into organizations such as EA will ensure
harmonization, remove barriers to trade and the free movement of laboratory professionals
whilst maintaining the high standards of practice essential to the proper care of
patients(Burnett [no date]).

Sri Lankan Situation

The accreditation scheme for Medical/Clinical laboratories is based on ISO 15189 Medical
laboratories – Requirements for quality and competence. Areas covered under this scheme
include Clinical Pathology, Clinical Biochemistry, Haematology, Microbiology and
Serology, Histopathology, Immunology, Molecular Biology, Pharmacology and Nuclear
Medicine Reliability and accuracy of test results issued by Medical/Clinical laboratories is a
critical issue in National Healthcare System. Reliability of test results is assured through
accreditation of Medical laboratories based on ISO 15189(Sri Lanka Accreditation Board
2018).

Several medical laboratories in the country have been accredited by ISO 15189:2007
standards. 15 out of those are private sector laboratories, while the National Blood Center is
the only government sector laboratory.

Although the accreditation ensures conformity to the standards, public of Sri Lanka do not
recognize a laboratory only by its standards. Public sector is ranked higher in the domains of
technical competency and low cost compared to the private sector in Sri Lanka. This nature
made people to seek medical care from government hospitals more than private sector
institutions. This factor may have led the government sector medical laboratories to give a
low priority towards accreditation.

But it is high time the government laboratories to obtain accreditation, especially with social
transitions and health tourism.
The need is well recognized at policy level. Medical Research Institute, which is the premier
center in the country for bio-medical and applied health research requires to be accredited
soon. External quality control programmes conducted by MRI would be an ideal platform to
moving towards accreditation.

Reference

1. Burnett, D. [no date]. Medical Laboratory Accreditation -The Road Ahead. Available at:
http://journals.sagepub.com/doi/pdf/10.1016/S1535-5535-04-00021-8.

2. Frenz, M. and Lambert, R. 2013. The Economics of Accreditation. Available at:

https://www.ukas.com/download/general_documents/Economics%20of%20Accreditation
%20Final%20Report.pdf.

3. Gaynor, M. 2006. Competition and Quality in Health Care Markets. Foundations and
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4. Gershy-Damet, G.-M. et al. 2010. The World Health Organization African Region
Laboratory Accreditation Process: Improving the Quality of Laboratory Systems in the
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at: https://academic.oup.com/ajcp/article-lookup/doi/10.1309/AJCPTUUC2V1WJQBM
[Accessed: 24 June 2018].

5. Peter, T.F. et al. 2010. Impact of Laboratory Accreditation on Patient Care and the Health
System. American Journal of Clinical Pathology 134(4), pp. 550–555. Available at:
https://academic.oup.com/ajcp/article-lookup/doi/10.1309/AJCPH1SKQ1HNWGHF
[Accessed: 24 June 2018].

6. Sri Lanka Accreditation Board 2018. Sri Lanka Accreditation Board. Available at:
http://www.slab.lk/AccOrgBialogicalTesting.aspx.

7. World Health Organization 2003. Quality and accreditation in health care services A
global review. Available at:
http://www.who.int/hrh/documents/en/quality_accreditation.pdf.