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David
Burnett
Consultant in Quality and Accreditation Systems
Member of EC4 Working Groups on CEN/ISO and Accreditation
Lindens Lodge, Bradford Place, Penarth CF64 1LA, United
Kingdom
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Introduction
Throughout the world there is an increasing interest among
medical laboratory professionals in attaining accreditation status
for their services. Although some may see this as a commercial
advantage, equivalent to a 'designer label', the main advantage of
working towards accreditation is the potential for more effective
management of the laboratory. The long awaited publication, in
February 2003, of the International Standard, ISO 15189:2003
'Medical laboratories-Particular requirements for quality and
competence'* provides a unique focus for this interest.
In the author's book, 'A Practical Guide to Accreditation in
Laboratory Medicine' key aspects of ISO 15189:2003 as well as ISO
9001:2000, the standard for quality management systems and ISO/IEC
17025:1999, the generic standard for testing and calibration
laboratories are discussed and through the fictional device of the
Pathology Laboratory of St Elsewhere's Hospital Trust, a practical
approach to establishing a quality management system is discussed.
This article presents a summary of this approach - from theory into
practice.
A process based
approach to quality management systems
In ISO 15189:2003 the management (quality management system) and
technical competence requirements are presented in two separate
sections making it difficult for laboratories to discover the
dynamic relationships between the quality and competence
requirements.
The starting point for developing a framework for process-based
quality management of a medical laboratory lies in the introduction
to ISO 9001:2000. It promotes the adoption of 'a process approach
when developing, implementing and improving the effectiveness of a
quality management system' in order 'to enhance customer
satisfaction by meeting customer requirements'. Process is
described as 'an activity using resources, managed in order to
enable the transformation of inputs into outputs'.
In the context of a medical laboratory this translates
into,consultation with users, receiving arequestforan examination,
carrying outthe workandreporting the results,
withinterpretationwhere appropriate.
Within any organization (e.g. a medical laboratory) there are
numerous interrelated or interacting processes, and it is 'the
identification and interactions of these processes and their
management', that is referred to as a 'process approach'. It is the
adoption of this approach that creates a process-based quality
management system.
The process-based model shown in Figure 1 represents the basics
of how a quality management system for medical laboratories work
irrespective of the content of the particular standard being used.
The references in brackets in each section are to the chapters of
PGALM.
Figure 1 A process-based quality management system for medical
laboratories.
The model shown in Figure 1 can be described in two different
ways. Firstly, the user has requirements that are formulated in
consultation with laboratory management (the request) and the
laboratory responds by carrying out pre-examination, examination
and post-examination processes to produce a report for the user.
Depending on whether their requirements have been met or not, users
may be defined as 'satisfied' or 'dissatisfied'.
The second view is that the laboratory management creates a
quality system (Organisation and quality management system) and
uses resources, staff, equipment etc. (Resource management) to
carry out pre-examination, examination and post-examination
processes (pre-examination, examination and post-examination
processes) to fulfil the requirements of the user. All aspects of
the quality system including the pre-examination, examination and
post-examination processes are continually evaluated and
improvements made as appropriate (Evaluation and continual
improvement). Evaluation and continual improvement activities
include for example, assessment of user needs and requirements,
internal audit of the examination processes and review of
participation in external quality assessment schemes.
Free publications prepared by the author (www.acb.co.uk)
show the clauses of ISO 15189:2003 and the CPA (Clinical Pathology
Accreditation (UK) Ltd) standards transferred into the process
based model illustrated in Figure 1.
The preamble to CPA Standard A4 in the 'Standards for the
Medical Laboratory' describes a quality management system as
providing '...the integration of organisational structure,
processes, procedures and resources needed to fulfil a quality
policy and thus meet the needs and requirements of users'. It is
this 'all embracing' concept of a quality management system that
this article seeks to emphasise.
Organisation and quality management system
Organisation and responsibility
For there to be an effective QMS, roles and responsibilities
must be clearly defined and laboratory management provide the lead
in establishing the sequence of action to be taken. This sequence
is illustrated in a pyramidal form on the left hand side of Figure
2. The first step in the sequence is the creation of policies that
can be defined as the 'overall intentions and direction of an
organization'. The second step objectives and plans, involves
'making plans and setting objectives to enable the fulfilment of
the intentions expressed in the policies'. The third step
processes, involves the 'definition of the activities needed to
carry out the intentions' and the fourth step procedures, are the
'practical way in which intentions are translated into action'. The
fifth and final step, records (made on forms) provide evidence, on
a day-to-day basis, that procedures have been carried out correctly
and that intentions have been fulfilled.
Figure 2 Action in quality management and a hierarchy of
documentation.
An example at St Elsewhere's would be that thequality policyof
the laboratory includes a commitment to the reporting of results of
examinations in a timely manner. The supplier of the laboratory
computer system announces the release of a module for ward
reporting of results. Laboratory management establishes the
installation of this module as anobjectivefor the next financial
year andplanningfor this development requires the inclusion of the
resource implications in the business plan. Its impact on
post-examination processes is defined andprocedures and
formsreviewed and revised.
Evidence of action in
quality management
Evidence of action in quality management is adduced from the
documentation that is used and illustrated on the right hand side
of Figure 2. The primary requirement for evidence is to enable the
laboratory to reconstruct its examination and other processes, when
this is required as a result of questions asked by users of the
laboratory concerning its performance. The other side of the
'evidence' coin is the need of assessors from accreditation bodies
to obtain evidence to enable them to assess a laboratory's
compliance with standards.
The quality manual in the Pathology Laboratory at St Elsewhere's
provides a road map to the whole documentation of the laboratory.
Figure 3 is a page from that manual showing the organisation and
responsibilities within the laboratory. In practical terms, the
manual should be no more than 25 pages in length. It contains a
quality policy and describes the processes that take place in the
laboratory in order to fulfil the requirements of particular
standards. Examples of such processes are the procurement of
equipment, the examination of specimens and the reporting of
results. A pathology laboratory can have a single policy statement
that is inclusive of all aspects of its work or there can be a
number of separate policies relating to different aspects of the
way in which a laboratory works.
Figure 3 St Elsewhere's Pathology Laboratory - Quality
Manual.
Throughout the quality manual there are references
toproceduresthat form the second level in the hierarchy of
documentation. Procedures are the practical way in which policies
are translated into action and describe how processes should be
carried out. They are often called SOP's or standard operating
procedures. The quality policy should refer to management, quality
evaluation, health and safety, and laboratory methods etc. and
procedures are needed which relate to the same areas.
In the same way that the Quality Manual refers to procedures, so
procedures can contain references to(working) instructions. This
third level of documentation involves the practical day-to-day work
instructions that are needed near the work situation for easy
reference. For example, they might describe, starting up or closing
down a haematology analyser. Instructions can be part of a
procedure or can be referred to in a procedure and published either
separately or both in the document and published separately. The
advantage of having them separate is that any changes to
instructions do not require a change to the procedure.
The final level in the hierarchy of documentation is theform(s).
These forms (and the records created using them) are a crucial part
of quality management. They are the evidence that a procedure
and/or related instructions have been carried out. If the procedure
or instructions require something to be recorded on a form, the
form should be referred to in the procedure. The forms or records
do not necessarily have to be created as 'hard copy' (a paper
record). A record (an electronic record) can be created by
completing a form on a computer screen in the laboratory or a
consultant's office, by anybody who has the correct authorization
identity. In a medical laboratory, request forms and test reports
are an example of such documentation. Records of any information or
data such as patients' results, minutes of meetings, quality
control data or the result of an audit must be made on forms of an
approved format and not on the backs of envelopes or the cuffs of
laboratory coats!
An example at St Elsewhere's would be a statement in thequality
policyrequiring 'the use of examination procedures that will ensure
the highest achievable quality of all tests performed'.
Theprocedureproduced as a result of such a policy statement would
be a procedure for measuring HbA1c. The procedure refers to
workinginstructionsfor starting the HbA1c analyser and for closing
it down and these are published separately and displayed near the
analyser for easy reference. The analyser is interfaced to a
laboratory computer and an example of aformis the
computer-generated work sheet to assist with checking-in samples.
Additionally, the computer file that holds the patient details and
results is regarded as arecord. Such computer-held data needs to be
as easily accessible on demand as any paper record.
All the documents referred to in the hierarchy above must be
subject to control as described below. The preparation of required
documentation might appear to be a daunting task for a medical
laboratory but when approached in a practical manner it provides
the basis of effective quality management the laboratory.
Document control
Control of documents requires that they are, approved for
adequacy prior to issue, reviewed and updated as required,
available at point of use, remain legible and uniquely identifiable
and that unintended use of obsolete documents is prevented. The
purpose of regularly reviewing documents is to ensure that they
remain fit for their intended purpose.
An inherent part of document control is a document register or
master index of documentation. It is important to decide at an
early stage whether the document register should be a manual paper
record, a homemade spread sheet or database or an off the shelf
(albeit customisable) commercial product. This is perhaps the most
important decision that any laboratory can make in building a
QMS.
Control of records
and clinical material
A major feature of all quality management systems is the need to
control process and quality records and, in the case of medical
laboratories, clinical material. Whether the requirement is for
control of clinical material or records, there are three distinct
issues to be considered. Firstly, are the records being retained
going to serve a useful purpose, for example to reconstruct an
examination, or to audit corrective action? Secondly, what are the
relevant retention times, and thirdly how should the material be
kept?
Resource
management
The management of resources is a key part of any QMS and at St
Elsewhere's the management of staff has a very high priority and in
particular the role of joint staff review. The agreed action points
(Figure 4) are seen as an essential part in the matching the
changing needs of the laboratory to the needs of an individual
member of staff. This is one example of the concept of 'circles of
continual improvement' discussed later in the article.
Figure 4 Joint staff review - agreed action points.
Pre examination,
Examination and post examination processes
At St Elsewhere's the provision of information for the user is
of top priority. This is in the form of a User Handbook (on a
hospital website) and by proper signposting of the laboratory.
There is little point in having a laboratory if the user or patient
cannot find it. Explanatory booklets include one explaining the
post mortem to relatives of a deceased patient.
Laboratory management has been devising ways in which to save
time and energy by increasingly using manufacturers material to
document procedures. An example is the documentation concept for
the BHM Analyser used by Biochemistry, Haematology and Microbiology
(Figure 5).
Figure 5 Documentation for the BHM analyser.
The provision of a consultative and interpretation service is
seen as an integral part of the service to the user
Evaluation and continual improvement
Evaluation and continual improvement
St Elsewhere's Pathology Laboratory has a commitment constantly
to evaluate its activities and seeking to continually maintain and
improve quality. Evaluation and continual improvement could be
regarded as synonymous with quality assurance, but it seems
increasingly uncertain what is meant by the term 'quality
assurance'. The difficulty seems to arise from the meanings of the
words 'assure' and 'ensure'. To try to ensure the quality of
something is 'to make sure or certain' of its quality, whereas to
assure 'to give confidence to oneself or others' seems a relatively
impotent activity if you view it from the point of view of the user
clinician.
Internal audit and
external assessment
Three different types of audit are distinguished at St
Elsewhere's. The first, is an internal audit conducted by the
laboratory itself on some aspect of laboratory activity such as the
accuracy of transcription of data from a request form into the
laboratory information system, or whether all members of staff have
up-to-date job descriptions. External audit (sometimes termed
assessments) conducted by some person or bodies interested in the
organization such as a purchasing authority or by external
independent organizations such as a national accreditation body. A
third type of audit, not shown in orthodox classifications is
cooperative audit. That is audit conducted between the laboratory
and another party for mutual benefit. Examples of cooperative audit
are clinical audit or customer satisfaction surveys and bench
marking activities. Schemes for external quality assessment that
are run on a primarily educational basis can in a sense be regarded
as cooperative audit or equally well classified as external audit.
Audits provide an important mechanism for the detection and
investigation of nonconformity.
Non-conformities /
corrective and preventative action
A non-conformity can arise in two distinct ways. Firstly, from a
reactive audit resulting from a problem in the conduct of a
process, leading to the need forcorrectiveand/orpreventive
actionand thus contributing to the maintenance of quality or
tocontinual improvement. Or secondly, a proactiveauditproduces
anon-onformitythat again requires corrective and/or preventive
action, thus contributing to the maintenance of quality or to
continual improvement.
An example of a reactive audit, illustrated by an example from
St Elsewhere's, was when the results from a new batch of quality
control material being introduced on an analyser showed all three
levels for each analyte were approximately 20% lower than expected
(a non-conformity). Investigation (an audit) revealed that although
the freeze-dried material had been reconstituted with 5 ml of
reconstituting fluid as per the documented procedure, the
manufacturer had changed the reconstitution volume from 5 ml to 4
ml without sending out a notice to this effect. All vials wrongly
reconstituted were immediately removed (corrective action).
Following this incident all personnel involved had the matter drawn
to their attention and the procedure was altered and an adverse
incident report might be dispatched to an appropriate government
agency, with a copy to the manufacturer (preventive action).
These actions contribute to ensuring the quality of
examinations, (continual improvement). An example of a proactive
audit would be a 'good housekeeping audit' and such audits are at
the core of maintaining a programme of continual improvement.
Continual
improvement
Examples of approaches to continual improvement are shown in
Figure 6 as what has been termed 'cycles of continual improvement'.
The intention of the diagram is to represent at the centre, the
management review as the core focus of all continual improvement
activity. The circles around the central circle represent
individual circles of continual improvement focused on specific
topics, for example, with Personnel, the activity is the annual
joint review of staff, with Internal audit of examination
processes, the vertical audit of examinations and with Equipment
and diagnostic systems, the procurement of In Vitro Diagnostic
Devices (IVD's).
An important question to answer at this point is when and how
often should these activities take place. These circles of
continual improvement should carry on throughout the year and most
of the nonconformities discovered have to be resolved in a
reasonably short time span for the process to be effective.
The non-conformities that are thrown up during the day-to-day
activities of quality management are the 'grist to the mill'
(defined in common English usage as 'anything that can be turned to
profit or advantage') of continual improvement, or the cogs in the
cycles of continual improvement.
However, during the course of a year, issues that require the
formal setting of new objectives and detailed planning will be
identified and these properly go forward as items for consideration
at the (annual) management review. If the results from an EQAS
indicate a problem with an examination, it is no good waiting until
the management review for its resolution, whereas the requirement
for new service provision may have to wait for the capital purchase
of the appropriate IVD or the recruitment of new staff.
Figure 6 Cycles of continual improvement.
Management review
At St Elsewhere's the annual management review is a crucial part
of the quality management system of the laboratory. It sets overall
objectives for the following year and within the laboratory these
are translated into objectives for the staff and thus into the
staff joint reviews that identify the training needs of those
staff. Continual improvement underpins the continuing provision of
a quality service that aims to meet the needs and requirements of
the user.
Acknowledgements and
sources
- Most of the figures and text in this article are based on the
author's book with permission from the publishers, ACB Venture
Publications. Burnett D, A Practical Guide to Accreditation in
Laboratory Medicine, (2002) ACB Venture Publications London (www.acb.org.uk).
The free companions to the book mentioned in the article can be
downloaded from the same website.
- A further valuable resource is 'Guidelines for quality systems
in medical laboratories', National Pathology Accreditation Advisory
Council, Canberra, Australia 2001 (www.health.gov.au/npaac)
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