CPA Transition to UKAS ISO 15189: 2012
Frequently Asked Questions
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General
Application
Assessment
General
Q
Why can’t there be an immediate transfer to ISO 15189?
The gap analysis between the CPA Standards and ISO 15189:2012 identified some key differences
that need to be assessed. In addition, UKAS cannot subcontract the assessment against ISO 15189 to
an accreditation body which is not a signatory to the Multilateral Agreements in place within the
global network. The number of laboratories involved in the transfer to ISO 15189:2012 combined
with the fact that we also need to assess against the CPA standards at the same time has been
considered in the four year timescale and factored into the formal project plan.
Q
How can we use the CPA/UKAS logos?
If a laboratory is successful in maintaining CPA accreditation then it can use the CPA logo. Once the
laboratory has been granted UKAS accreditation against ISO 15189 it can then use the UKAS medical
symbol and must cease to use the CPA logo. All laboratories should be aware of the relevant UKAS
publications on the UKAS website; please refer to URN BIS 16/25 and LAB 1 for information and
advice on the use of the UKAS symbols. In a multi-disciplinary site where one site is CPA accredited
and the other is UKAS accredited, it must be made very clear to the users which tests are ISO 15189
accredited, which are CPA accredited, and which (if any) are not accredited at all. This could be
communicated through the user guide or on laboratory reports for example. Use of the UKAS symbol
will be assessed at the first ISO 15189 surveillance visit.
Q
How will our accreditation be displayed on the website?
Each ISO 15189:2012 accredited medical laboratory will have a Schedule of Accreditation which
identifies all activities and examination procedures that the laboratory is accredited for. This will be
published on the UKAS website and is publicly available (unless otherwise requested). The website
includes a search facility for users of laboratory services to find accredited medical laboratories and
also a browse feature which allows users to find lists of accredited medical laboratories by discipline.
Q
Are there any opportunities for sharing best practice?
Yes - Gap analysis, IBMS Conference, multi-site laboratories where expertise may be available at
other sites; professional bodies; assessors input.
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Q
Will the costs for assessors and their time be the same as for CPA?
Please see the CPA fees document published on the UKAS website. Following transition to ISO 15189
accreditation, laboratories will have a technical assessment every year instead of every four years as
was the case under CPA. Consequently, there tends to be a slight increase in fees but a bespoke
estimate is provided for each laboratory based on their scope which constitutes the offer of
accreditation. Laboratories have the opportunity to query this prior to signing the offer of
accreditation.
Q
We have a CPA surveillance visit due before our transition assessment, how much of this
process applies?
Most CPA surveillance visits are now complete. Any outstanding CPA surveillance visits will be
against the CPA Standards only. You may be asked about preparations for ISO 15189 at your visit and
your Assessment Manager will be happy to respond to any queries that you have about UKAS
accreditation.
Q
Why do we need to maintain CPA accreditation?
Your users may rely on your accreditation and you may not gain ISO 15189 accreditation straight
after your initial assessment due to the timescales involved. This allows you to maintain some form
of accreditation and avoid any periods without accreditation.
Q
Section 4.13 of ISO 15189:2012 references two clauses that don’t seem to exist?
This has been corrected, see BS EN ISO 15189:2012 Incorporating corrigendum Oct 2014.
Q
How does ISO 15189 link to the MHRA standards?
We look at things in slightly different way and we do not replace what MHRA are doing as the
regulator. The requirements of ISO 15189 can be cross-referenced with the MHRA regulations.
Q
Should the focus of our audit process be changed to fit ISO 15189?
You need to make sure your audit schedule is compliant with your management system and ISO
15189.
Q
Is UKAS subject to Freedom of Information (FOI) requests?
No, UKAS is not subject to FOI and maintains client confidentiality. The UKAS Agreement reflects the
confidentiality agreement.
Q
Will laboratories have time to prepare for the transition?
Laboratories have had sufficient time to prepare and we recommend all laboratories complete a gap
analysis against ISO 15189:2012. If a laboratory has not completed a gap analysis, this may
compromise the assessment against ISO 15189 and a further visit may be required to establish
conformity, which will be chargeable.
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Application
Q
How do we complete an AC6 form? Can we group specimen types together?
It depends. If you are using the same process then it is fine to group them together. If you use
different processes then you would list them separately. It’s best to group tests by method, so for
example list one analyser/method and then list all examinations for that analyser/method. Then
move on to the next. Referred tests cannot be included with a view to including them in the scope of
accreditation.
Q
What if we do not declare a test in our repertoire on our ISO 15189 application?
Your application is the basis of the scope of assessment and if a test is not assessed, then you won’t
be accredited for it. There is an expectation that laboratories apply for accreditation for the full
scope of their activities (as under CPA) and any testing that is not applied for must be clearly
disclaimed as such to users of the service. On application, the laboratory will inform UKAS of the
scope to be assessed and accredited and you are also required to list any testing that you are not
applying for. This allows UKAS to ascertain why, for example you may think the test cannot be
accredited but this may not be the case. You don’t have to be accredited for absolutely everything
you do and what you are accredited for will be displayed on your Schedule of Accreditation but you
should be aware that UKAS will assess against ISO 15189 4.14.2; Periodic review of requests, and
suitability of procedures and sample requirements to ensure that the examinations provided by the
laboratory are clinically appropriate for the requests received.
Q
If we have several CPA accreditations, do we need to submit several ISO 15189 applications?
No, if you are using the same quality management system then a multi-disciplinary/laboratory
application should be considered and may be helpful. Laboratories with differing CPA reference
numbers may not all be due for assessment at the same time due to the CPA visit schedules, so
please include all the CPA reference numbers that the ISO 15189 application covers in the
application form.
Q
We’re not CPA accredited for some disciplines that we would like to include for ISO 15189
assessment, do we have to apply for CPA accreditation as well?
No, if the discipline was not previously CPA accredited it will only be assessed against ISO 15189 and
no transition assessment is needed. In these instances the laboratory should apply to UKAS as a new
customer using the normal UKAS application forms.
Q
How does ISO 15189 fit in with Point of Care Testing?
For POCT accreditation, the assessment is against ISO 15189 and ISO 22870 (the transition
application form includes tick boxes for ISO 15189 and for ISO 22870). Organisations accredited for
POCT will be transitioned to ISO 22870 when they are due their ISO 15189 assessment. New
applicants for POCT accreditation should apply directly to UKAS for ISO 15189/ISO 22870.
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Q
What happens if we change our scope or there is another major change after application but
prior to our assessment?
You must inform your Assessment Manager/UKAS of any changes as soon as possible as the
assessment will be arranged to specifically cover the scope of application. Depending on what stage
the visit arrangements are at, it may be possible to adjust the assessment to accommodate the
changes, or it may be necessary to conduct a further assessment which will be chargeable.
Assessment
Q
Do assessments against ISO 15189:2012 include training and development?
Yes, section 5 of ISO 15189:2012 includes requirements for staff qualifications, training, competence
and CPD. An assessment of competence is central to accreditation to ISO 15189:2012.
Q
Is there an intention to maintain 2 yearly visits or go to annual visits?
In order for UKAS to comply with ISO 17011 (the standard which all national accreditation bodies
must comply with), we need to ensure that we assess all critical components of the accredited scope
of medical laboratories over a four year cycle. To establish this, some form of assessment activity
will need to take place on an annual basis. This is likely to be in the form of a visit which may or may
not include a technical assessor but will include some form of technical/clinical assessment.
Q
What are the timescales associated with the submission of evidence to clear findings?
A laboratory has three months to submit evidence to clear all findings raised at the transition
assessment. Once received, the turnaround time for providing feedback to the laboratory is four
weeks. If further work is required, the laboratory is notified and given another two weeks to submit
additional evidence to close the remaining findings. Findings should be cleared in a timely manner in
order to maintain CPA accreditation, and ultimately to grant ISO 15189 accreditation.
Q
What are the consequences of non-clearance after two submission cycles?
UKAS will review the impact of the protracted clearance and take appropriate action such as
arranging an extra visit. If the laboratory is accredited by CPA or UKAS against ISO 15189:2012,
sanctions such as suspension of accreditation can be imposed.
Q
Will any findings from a transition visit relate to the CPA Standards only?
No, ISO 15189 contains all of the CPA requirements and more. From our experience so far, broadly
speaking 75% of findings will relate to both CPA and ISO 15189 and 25% will be ISO 15189 only.
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Q
Will there be transparent decisions?
If this relates to the awareness of which laboratories are accredited by UKAS to ISO 15189:2012 then
yes, the schedules for these laboratories are published on the UKAS website. The schedule indicates
which examinations and activities are accredited at which location(s).
Q
Will it still be a four year cycle?
Yes, three surveillance activities for years one to three with a full team on site for reassessment in
year four.
Q
Will there be an annual re-registration?
CPA Annual Re-registration forms are no longer required in order to maintain CPA accreditation,
although you must inform your Assessment Manager/CPA of any major changes.
Q
What is the accreditation plan?
A four year plan to assess and witness all critical techniques is formalised by the Assessment
Manager during the ISO 15189 transition assessment process. This is usually adhered to however
certain events may prompt for an alteration to the plan such as a change to an accredited
procedure.
Q
What about historic examination procedures without any history of validation/verification?
UKAS expects collated/authorized evidence showing evaluation and validation/verification of the
procedure. This could be a report on performance using EQA, IQC, verification data etc. and should
include a rationale/justification as to why it is fit for purpose.
Q
CE marking, thoughts on this?
CE marking doesn’t give you complete traceability of reagents and by itself does not confer fitness
for purpose. The laboratory needs to review information provided by the manufacturer to establish
that the validation demonstrates fitness for the purpose in an appropriate context of use and then
to verify the performance. Please refer to the validation document available on the UKAS website for
further information.
Q
What about those manufacturers who won’t provide information because of commercial
sensitivity?
Manufacturers should be willing to provide information which will assist laboratories in making an
informed judgement. If not, the laboratory needs to evaluate the impact of this missing information
and take appropriate action.
Q
What about measurement of uncertainty?
Laboratories shall determine uncertainty of the result if the examination procedure is quantitative.
The mechanism to quantify this should include all/any pre examination, examination and post
examination measurements. If a result is not numeric i.e. qualitative, all aspects of the process will
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need to be reviewed to establish if there is a measurement step e.g. temperature, weights, volumes
to determine the result. For example, was a limit of detection established in order to issue a ‘not
detected’ result?
Q
Flexible scope of accreditation; can Medical laboratories involved in the transition from CPA
accreditation have this assessed from the start or is it fixed?
Initially it will be a fixed scope as laboratories need to identify the examination procedures to be
assessed. UKAS also needs to establish confidence in the validation and verification procedures and
awareness of accreditation requirements. In the future UKAS will offer and assess for a more flexible
scope, dependent upon the relevance and readiness of the laboratories involved. In theory,
laboratories can apply for a flexible scope at any point after being accredited.
Q
What are the timescale for warning laboratories about a visit and submission of pre-visit
documents?
Planning for assessments normally starts six months in advance although this may vary depending
on the circumstances. The visit plan is usually sent to the laboratory four weeks prior to the visit
date, which will include a request for certain documents/records to be submitted 2 weeks prior to
the visit date (e.g. current quality manual, SOPs and validation for examinations to be witnessed). It
is acceptable to send cleansed versions of any documents/records that include patient information
to maintain confidentiality (although it should be noted that UKAS employees and assessors are
bound by a confidentiality agreement).
Q
What is the implication for referred tests?
Referred tests (‘sendaways’) are not included on the Schedule of Accreditation of the referring
laboratory and should not be included on the application documents (AC form). UKAS will assess
how the laboratory selects and evaluates referral laboratories and consultants who provide
opinions, as well as interpretation for complex testing, to ensure competence and that the relevant
parts of ISO 15189 are met.
Q
What if we disagree with the Technical Assessors?
This is very unusual and it would be managed on a case by case basis. There would need to be
scientific justification and evidence provided to the assessor on the day. There is an emphasis on
findings being factual and not a matter of personal opinion which minimises disagreements of this
sort. If any Laboratory Managers find themselves in this position they should refer the matter to the
Assessment Manager in the first instance.
Q
Verification re methodology and instruments – staff coverage?
All staff who perform the test should be included, not just specific or expert staff, and there should
be a range of competent staff. There is no requirement to repeat the work done by the
manufacturer but the laboratory must have confidence in the performance claims made.
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Q
Can you give us guidance to meet the requirements of ISO 15189 for example, ideas of what
other laboratories have done?
UKAS cannot provide any consultancy services so we will never say “we recommend you do it like
this”. It is much more of a discussion with you telling us how you will correct something based on
what you do. We cannot share details of other assessments; however UKAS encourages all
laboratories to establish a dialogue with others to share best practice. There are forums and
professional bodies available in most areas and disciplines which may help.
Q
Will there be a user group meeting with clinical colleagues as there currently is on CPA visits?
No there will not. Sometimes we find that the benefit of meeting users is limited however, that’s not
to say we won’t be looking at how you interact with the users and how you deal with the
information collected from users in your management system etc.
Q
Do you anticipate that UKAS will be able to do unannounced assessments?
It is possible that NHS England, the CQC or other interested stakeholders in Scotland would require
us to do unannounced visits. We may also do unannounced visits in response to a specific complaint.
It largely depends on the circumstances, but is certainly within the breadth of UKAS’ tools.
Q
Is there a mechanism for including a new test or major change post-assessment?
Yes, you would need to inform your Assessment Manager/UKAS about the change as early as
possible. Depending on timing and the wishes of the laboratory, this could be assessed with an extra
visit or an extension to scope either prior to, or following, grant of accreditation against ISO 15189. It
is likely you would need to provide an updated AC6 form.
If this involves a new test that is completely different to what has previously been
assessed/accredited then we may have to visit with a Technical Assessor to look at it. If it involves a
test that uses an analyser or method that we’ve already assessed, then we may be able to do a
remote assessment.
Other major changes such as laboratory mergers or changes to legal entity will be assessed on a case
by case basis and may require site or remote assessment.
Q
Interim pipette checks on pipettes calibrated by external accredited laboratory – how much
detail should the interim checks involve and how frequent should the checks be?
This is for the laboratory to decide and justify to the assessor based on the impact of an incorrect
measurement to the examination results and the demonstrated stability of the pipettes.
Q
Should there be SLA Agreements in place with other departments and hospitals?
The standard does not specifically require formal agreements; however roles and responsibilities
need to be defined and agreed and SLAs are a useful way to do this. SLAs for the provision of medical
laboratory services should include the requirements of section 4.4. If formal agreements are not in
place for all requests received then the laboratory needs to demonstrate how it meets the
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requirements of section 4.4 for those requests, for example by including information for both parties
in the user guide and request forms.
Q
How does UKAS assess clinical staff competency?
We will assess how the laboratory has defined, documented and implemented their policies and
processes for the initial and on-going assessment of clinical staff competency. The assessor will then
use their technical expertise to judge whether this is effective. Mechanisms typically used by
laboratories to assess clinical staff competency include, but are not exclusive to, qualifications,
experience, appraisal, interlaboratory comparison, and inter/intra individual audit and/or
comparison of reports and clinical interpretation. Please refer to the Assessor Update document
available on the UKAS website for further information.
Q
What would happen at assessment if we did not hold historical records according to the
RCPath guidelines, due to de-merge of Trusts for example?
The RCPath document provides guidelines for storage/retention. The laboratory should ascertain
which relevant documents/records they do not hold, assess the impact of this and have contingency
plans in place should the records be required for example, in a court of law.
Q
How does the introduction of lay assessors affect UKAS assessments?
UKAS are currently working with the CQC and it is likely that lay assessors will only be necessary at
Initial/Transition assessments and will not always need to be involved. If lay assessors are used, they
will only look at customer facing services e.g. phlebotomy.
Q
With regards to fridge/incubator etc. thermometer calibration, how far back does traceability
need to be?
It depends on what the equipment is used for and how critical the temperature is. If it is critical, full
traceability needs to be demonstrated, for example by having the thermometer calibrated by a UKAS
accredited ISO 17025 calibration laboratory. It may be adequate for the laboratory to purchase a
traceably calibrated reference thermometer and to check the laboratory thermometers against this.
UKAS would then assess the competence of the laboratory in management of the reference
thermometer and in carrying out the checks.
Q
Are we able to use judgement of senior staff within SOPs?
It depends. Wherever possible there should be established criteria against which a judgement is
made, for example, when an IQC result acceptable or not or when tests should be repeated to avoid
inconsistency in approach/implementation. See also section 5.1.2 ‘The personnel making judgments
with reference to examinations shall have the applicable theoretical and practical background and
experience. NOTE Professional judgements can be expressed as opinions, interpretations,
predictions, simulations and models and values, and should be in accordance with national, regional
and local regulations and professional guidelines’.
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