Transcript Creativity Session - Institute of Biomedical Science

IBMS Scottish Quality
Management Discussion
Group Meeting
Perth – 20th May 2008
1
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Standards Revision
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Some of the New Clauses
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Standards revision
2 reasons for revision
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STEG undertook a gap analysis between the
CPA standards and the original ISO
15189:2003
In addition the revised ISO 15189:2007
was published internationally
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Standards revision
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Implementation
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CPA published in September 2007
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Regional assessor training December 2007
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Peer assessor training April 2008
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First assessments April 2008
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One year to allow for all laboratories to be
compliant
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Standards - future
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There is a revision of ISO 15189 at
present
Due date for publication was 2009
May be a delay as the first edition of
the revised standard was rejected a
few weeks ago
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Standards - future
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CPA has to decide whether to take the
step towards assessing to ISO 15189 in
future
If agreed it assists with introduction of
other related standards e.g. ISO 22870
POCT
This in itself is cross referenced to ISO
15189
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The Revised
Standards
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A1 Organisation and
management
A 1.4 a)
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Define the organisation and management of the
laboratory, its place in a parent organisation and
its relationship to any other organisation with
which it may be associated
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A2 Needs and requirements
of users
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New clause 2.4
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Where management enters into a formal
agreement to provide medical laboratory services,
it shall establish a documented procedure for the
establishment and review of such agreements…
Standard does not require formal agreements but
if they have been set up a procedure must be in
place to comply with clauses a) – h)
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A3 Quality policy
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A 3.1a)
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The scope of the service the laboratory
intends to provide.
A general statement as to the scope of the
service provision is all that is required
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A8 Document control
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Note 2
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If in exceptional circumstance the document
control system allows amendments of documents
by hand
Procedures and authorities for such amendments
are defined, and pending re-issue, documents
clearly marked, initialled and dated revised
document re-issued as soon as practicable.
Must be identified within document control
procedure
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B1 Personnel
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B1 Laboratory Director
Are clauses a) – n) documented eg in job
descriptions of Laboratory Director or
delegated staff
 Evidence of competence is derived from
compliance with other standards
 Inputs v outputs
 responsibility v competence to assume
responsibility
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B6 Staff records
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B 6.2 h)
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A record of competency assessments
What is a record
 where should it be kept
 links in with B9.3
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B9 Staff training and
education (1)
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B 9.1a) training and education shall be in
accordance with the policies of the parent
organisation and guidelines from the relevant
professional and registration bodies
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Access to continuing education and training is
important for all grades of staff and has to take
cognisance of any parent organisation policies
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B9 Staff training and
education (2)
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B 9.2
 The training programme shall, as appropriate,
include the following clauses
 a) assigned work processes and procedures
 b) the quality management system
 c) applicable computer system(s)
 d) health and safety including the prevention or
containment of the effects of adverse incidents
and
 e) the ethics and confidentiality of information
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B9 Staff training and
education (3)
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B 9.3
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Competency to perform the assigned task shall be
assessed following training and periodically
thereafter. Retraining and reassessment shall
occur when necessary. Records of competency
assessments shall be kept
Laboratory determines what is appropriate for
individual staff member
Training programmes to reflect this
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C Premises and environment
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C1.1 note
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Particular attention should be given to
monitoring, controlling and recording
environmental conditions as required by
relevant specifications or where they may
influence the quality of results…….as
appropriate to the technical activities
concerned.
If relevant to the analyses records need to
kept
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E Pre-examination process
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E2 request form
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E2.3 the laboratory shall determine in
discussion with users the manner in which
requests (including verbal requests) are to
be communicated to the laboratory.
Evidence of this being discussed with users
and the outcomes of these discussion being
recorded and acted upon
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E Pre-examination process
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E5 specimen reception
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E5.3 Authorised personnel shall systematically
review requests and samples and decide which
examinations are to be performed and the methods
to be used in performing them.
Needs to be clearly defined eg in specimen
reception procedure who is authorised to route
samples through the laboratory and make decisions
about test selection
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E Pre-examination process
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E5 Specimen reception
Note 1: This includes linking the primary
specimen to any sample portions prepared
in reception or subsequently.
 Appropriate labelling of
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Aliquots
 Isolates
 Histology blocks, slides etc
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E Pre-examination process
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E6.1
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Evaluating and selecting referral laboratories and
consultants in terms of competence to perform the
requested examinations and ensuring that there
are no conflicts of interest.
Procedure should outline
How referral labs/ consultants are selected.
What measures of competence are included in
selection process
What measures are in place to ensure no conflict
of interest.
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F Examination process
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F2.1h
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Limitations of the examination, including
interferences, cross reactions and
reportable intervals
Have the upper/lower assay ranges been
identified as opposed to normal reference
range?
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F Examination process
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Note 1.
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If the laboratory utilises the instructions
for use written by the manufacturer, they
shall be in accordance with the criteria set
out in F2.1. Any deviations shall be
validated, reviewed and documented
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F3 Assuring the quality of
the examination
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F3.1
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The laboratory shall ensure the quality of
examinations by performing them under
controlled conditions that include as
applicable:
Fulfilment of the criteria of clauses a) – g)
are covered by other standards as
indicated in F3.1
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F3 Assuring the quality of
the examination
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F3.3
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The laboratory shall determine the uncertainty
of results, where relevant and possible.
Need to recognise the difference between
uncertainty of measurement and uncertainty of
results
Refers primarily to numeric disciplines
Includes all factors impacting on assay, eg
correct preparation of patient, sample labelling,
sample tube, environmental factors in lab etc
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F3 Assuring the quality of the
examination
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ISO 15189 5.6.2
 The laboratory shall determine the uncertainty of results
where relevant and possible. Uncertainty components
which are of importance shall be taken into account.
Sources that contribute to uncertainty may include
 Sampling
 Sample preparation
 Sample portion selection
 Calibrators
 Reference materials
 Input quantities
 Equipment used
 Environmental conditions
 Conditions of the sample and changes of operator
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F3 Assuring the quality of
the examination
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F3.4
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The laboratory shall have a programme of
calibration of measuring systems and verification
of trueness designed to ensure that results are
traceable, where possible, to SI units or to a
stated reference material
We recognise that this is major addition to the
existing standards and have asked the members of
PAC to prepare a discipline specific response
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F3 Assuring the quality of the
examination
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ISO 15189 5.6.3
A programme for calibration of measuring systems and
verification of trueness shall be designed and performed so
as to ensure that results are traceable to SI units or by
reference to a natural constant or other stated reference.
Where none of these is possible or relevant other means for
providing confidence in the results shall be applied including
but not limited to:
Participation in a suitable programme of inter laboratory
comparisons
Use of suitable ref., materials certified to indicate
characterisation of the material
Examination or calibration by another procedure
Ratio or reciprocity type measurements
Mutual consent current standards
Documentation of statements where traceability is provided
by the supplier or manufacturer of reagents
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F3 Assuring the quality of
the examination
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F3.5
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The laboratory shall have a mechanism for
ensuring that examinations performed using
different procedures or equipment or at
different sites give comparable results,
throughout clinically appropriate intervals.
What is the mechanism?
Are results audited?
What is clinically appropriate intervals
Peer assessors domain
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G Post examination phase
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G2.3k where possible the identification
of person(s) verifying results and
authorising the release of the report.
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Where possible
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G Post examination phase
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G 5 Clinical advice and interpretation
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G5.4 There shall be systematic communication
between laboratory staff and clinical staff to
promote effective utilisation of laboratory
services and to consult on scientific and logistic
matters. Where appropriate a record of such
meetings shall be kept.
Evidence to show systematic communication eg
MDTs, user fora, newsletters,
questionnaires/surveys
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H Evaluation and quality
assurance
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H5 External quality assessment
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When a formal inter-laboratory comparison
programme is not available, the laboratory shall
develop a mechanism for determining the
acceptability of procedures not otherwise
evaluated.
If no EQA scheme exists what systems have been
put in place?
May include exchange of samples and preparations
such as slides and digital images
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H Evaluation and quality
assurance
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H6 Quality improvement
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H6.1 process for continual quality
improvement shall include remedial action,
corrective action, preventive action,
monitoring of quality indicators and
improvement processes
What are the laboratories quality
indicators and how are they monitored?
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H Evaluation and quality
assurance
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H 6.2 corrective action shall be taken to
eliminate the root cause of non
conformities. Corrective actions shall be
appropriate to the effects of the
nonconformities encountered.
Root cause analysis
 Results recorded
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H Evaluation and quality
assurance
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H6.4 the laboratory shall establish
quality indicators to monitor and
evaluate performance…… shall be
established prior to implementation
Customer, user and worker complaints and
satisfaction.
 Laboratory safety and environment,
 Continuing education
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H Evaluation and quality
assurance
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H7 New Standard
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Identification and control of
nonconformities.
Procedures required to ensure that
nonconformities are effectively managed
to minimise the risks to users
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Standards Revision
Some of the New Clauses
37
Thank you
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IBMS Scottish Quality
Management Discussion
Group Meeting
Perth – 20th May 2008
39