Transcription
This bite-size session will give you an introduction to medical laboratory accreditation performed by UKAS in the UK and give you an introduction to the ISO 15189 standard.
Within the UK, UKAS accredits a number of different types of health care services including diagnostic imaging services, medical physics and clinical engineering, physiological sciences, and medical laboratories including point of care testing services. Medical laboratories are accredited to ISO 15189, which is an international quality standard specifically aimed at medical laboratories. It's based on ISO 17025 which is an international standard aimed at testing laboratories and calibration services. But 15189 includes some of the clinical service requirements which are absent from 17025.
15189 is split into a number of different sections including general requirements, structural and governance requirements, resource requirements, process requirements, and management system requirements. There's also a separate annex at the end relating specifically to point of care testing services. I'm going to spend a few minutes now running through the key requirements of each of these sections to give you a really good overview of ISO 15189 standard requirements.
Section four is a very general section and the key areas included in this section include impartiality and confidentiality. Impartiality requirements relate to ensuring that services are delivered without any impartiality concerns. They're free from financial burdens and they're free from conflicts of interest or if there are conflicts of interest, they're declared and managed. Confidentiality is obviously critical when dealing with a healthcare service which will have access to patient records and patient information.
Section five looks at the structural and governance requirements of a laboratory service. The key section here is relating to legal entity. It needs to be very clear which organization is taking legal responsibility for the service provided because we will accredit the legal entity service. The laboratory director role is also a key role because this is the person that takes ultimate responsibility for service delivery. Often the laboratory director is performed in combination with the role of medical director or clinical lead but not always. You can have separate laboratory directors who work in conjunction with medical directors and clinical leads.
Section five also looks at the laboratory's advisory activities. So, how we advise users on the choice of examinations, how we provide professional judgments, and how we provide guidance on effective use of examinations, which could include things like minimum retesting intervals. So, you're not asking patients to have unnecessary blood tests, for example, if a test only needs to be done at a certain frequency.
Section five also looks at the organizational structure. So where does the laboratory sit in the wider organization and it has some of the quality management system requirements relating to objectives and quality indicators that demonstrate that a service is a clinically appropriate service and it's meeting the needs of its patients and its users.
Section five introduces the concept of risk management. Risk management is a big part of all the ISO standards now. So it's really important that laboratories read and understand this requirement.
Section six looks at resource requirements. So this isn't just staff, this is facilities, laboratory facilities. This is equipment. This is reagents. There's lots of different resources that are required in order to deliver an effective medical laboratory service.
So under personnel we're looking at do laboratories have the right number of staff with the right level of competence and authorization? Are they performing CPD? Under facilities, are the laboratory spaces adequate? Are they appropriate? Are they secure? Do they have the right environmental monitoring etc. to deliver an effective service? For equipment and similarly for reagents we're looking at acceptance testing of those equipment or reagents. Is there appropriate storage of reagents? Is there appropriate maintenance of equipment? Are incidents and issues etc. identified and managed?
There are also requirements elements in this section relating to calibration and traceability. So if a piece of equipment needs to be traceably calibrated, is that process in place and are there records?
Section six also includes requirements relating to service agreements and externally provided products and services. Under service agreements, this would be making sure that both the laboratory and its users are clear regarding responsibilities, who does what, where and when in the pathway. And externally provided products and services relates to procurement of equipment or calibration testing services or selection of referral services and all sorts of other external products and services. Does the laboratory have appropriate processes in place and does it have appropriate selection criteria and monitoring?
Section seven is a large part of the standard because this basically covers the testing process, from pre-examination through to release of the results. In the pre-examination section, there are requirements relating to user information, sample collection, sample transport, test requesting, etc.
In the examination processes section, we need assurance that methods used are appropriately validated or verified where appropriate, measurement uncertainty has been defined, that there are appropriate reference intervals, clinical decision values in place for each of the tests and there are SOPs in place which actually tell the staff what to do and how to do it.
Section seven also covers the quality control and quality assurance processes that a laboratory must have in place. So there are requirements relating to IQC and EQA. If a laboratory doesn't have subscription to an appropriate EQA scheme or if there isn't an appropriate EQA scheme available, they the service needs to provide evidence to UKAS of how they're managing this. What's the alternative mechanism in place to provide assurance that results are comparable with other laboratories of a similar type?
Section 7.4 looks at post-examination processes. So when a test result is available, how is that result reviewed, interpreted and released to appropriate users or requesters? It also looks at critical results. So if there's an urgent result or an abnormal test result or just something that needs to be communicated as a priority to the users, how is that managed? What processes are in place? Who gets contacted about that result?
There are also requirements relating to post-examination sample handling and storage because a laboratory might need to go back to that same sample at a later date to do further testing.
Within section 7, there are some less technical requirements. So these relate to non-conforming work, control of data and information, complaints and service continuity. Non-conforming work relates to how are issues and non-conformances identified and managed. Similarly with complaints, how are they received? This might be a formal complaint or an informal comment, but it still needs to be handled as a complaint and investigated, reviewed, and fed back to the complainant.
This section looks at IT systems and how they are tested, implemented, rolled out, etc. How any upgrades are managed and how the lab has assurance that any electronic test requests are received into their system and how any electronic results are released to users and received by users and are complete when they're received.
Service continuity requirements relate to contingency situations. So what processes a laboratory has in place to ensure that the service continues to function when there's for example a power failure, an equipment failure, a seasonal flu. So there's a lack of staff.
Section eight is the last section of the standard and really relates to the management system or quality management system. And this is the system and the processes that underpin the technical service delivery to make sure that everything functions as it should function and that there is good oversight of the processes.
So this section includes things like making sure that staff are aware of the management system and their actions and responsibilities relating to that. It also looks at documentation. So how are SOPs and other records and policies and processes etc kept up to date? How are new updates to national best practice documents identified and incorporated into the clinical pathway and into each laboratory?
This section also looks at control of records. So which records are stored, how long are they stored for, where are they stored, why are they stored for that amount of time. And there's another reference to risk management. So this was started in section five and it's built on in section 8 where laboratories are expected to identify risks, identify improvement opportunities, obtain improvement and ideas and continual feedback from their own staff and from their service users.
And there's also requirements in this section relating to management of non-conformities. Again, building on earlier requirements in section seven. So this is all about making sure that when something does go wrong, appropriate action is put in place for that particular incident, but also actions are put in place to stop things going wrong again.
There are requirements related to the laboratory's evaluation of its own service. So again building on an earlier requirement relating to quality indicators. So making sure that lab management know what indicators are in place and whether the performance against those indicators is appropriate and also auditing. It's very important that the service audits its own service to make sure that all of the processes are functioning appropriately.
The last requirement in section 8 relates to the management review. So this is a requirement that laboratory management services and teams and personnel periodically review their service and make sure that it's still fit for purpose. It is still delivering good service to patients and other users and that the tests are still clinically appropriate. The resource requirements are still appropriate. Audits are still in place. Quality indicators are being monitored and performance is good or action is being taken if performance isn't good. It's basically a look back at how things have been and how the service is running.
The last part of the standard is an annex which relates specifically to point of care testing services. Point of care testing services all need to comply with all of the requirements of 15189 throughout sections 4, 5, 6, 7, 8. But there is a specific additional annex that just gives a little bit more guidance and a few more hints and tips about how to run an effective point of care service.
Hopefully this session has given you a good introduction into the requirements of ISO 15189. I will help you to incorporate those requirements into your service and continue to deliver a continually improving service for patients.