For queries about the service please contact the Queen Elizabeth University Hospital Biochemistry Department on 0141 354 9060.
About the service
The Scottish Biologic Drug Monitoring Service is delivered by the Biochemistry Dept. within the Lab Medicine Building on the Queen Elizabeth University Hospital site, Glasgow.
The service currently delivers Infliximab and Adalimumab levels and their respective total anti-drug antibodies (ADA) for optimising care predominantly in gastroenterology patients with inflammatory bowel disease. The service uses both WHO standards for drug levels and a patient pool sample for ADA assay to monitor performance. It is involved in sample exchange with other laboratories.
The service employs a reflex ADA testing strategy based on drug level result. When a drug level result is within or higher than the therapeutic target range, and when ADA level has previously been undetectable, reflex ADA testing is not routinely performed. Since the introduction of reflex ADA testing approximately 50% adalimumab samples and 37% infliximab samples have not had a reflex ADA test performed.
There may be some clinical scenarios where ADA titres are desirable even when drug level results are therapeutic. Requests for additional ADA testing should be indicated clearly at the time of test request or can be arranged by contacting the lab directly.
During 2019 there were 2821 Infliximab and 2920 Adalimumab samples analysed from health boards across Scotland.
TDM tests should be requested according to local biochemistry/immunology laboratory requirements. The previously used paper request forms are no longer required. Local teams are encouraged to collate data related to TDM use and outcomes as this may be required to sustain future rounds of service funding.
Vedolizumab drug level testing is now available. The utility of testing drug and anti-drug antibodies for vedolizumab has yet to be fully ascertained. Target drug levels for vedolizumab have not been clearly established. The current evidence is covered in these articles:
Vedolizumab testing is not part of the nationally commissioned TDM service. The cost per sample is £20.
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Clyde Biochemistry Laboratories (those based at Royal Alexandra Hospital, Inverclyde Royal Hospital and Vale of Leven Hospital) has been accredited with UKAS to standard ISO 15189:2012 for much of our test repertoire. The certificate of accreditation is available online.
The scope of our accreditation includes the majority of the tests performed by our laboratories, with a small number of tests not falling within our accreditation status (for example, no fluid analyses (on fluids other than CSF, urine or blood / serum / plasma) are accredited) – see the link above for details of our accredited scope.
Specialist services including Protein Electrophoresis and less often requested endocrine assays are based at RAH.
All routine GP work within the Clyde Sector is also based at RAH.
Please accept our apologies for the behaviour of links on this webpage. This is due to a global setting which is outwith the Biochemistry Department’s control.
We are committed to providing a quality service to users. If you wish to provide feedback on the Clyde Glasgow Biochemistry service, please contact our Quality Manager by emailing Pamela.craig6@nhs.scot
Full details of the services provided by other Scottish Genomic Network Laboratories, including request forms, can be found on the Aberdeen, Dundee and Edinburgh laboratory websites.
A list of all genomic tests commissioned by NHS England for rare and inherited disorders, and cancer can be found in The National Genomic Test Directory.
Service Status
NPM1 MRD: Communication has been received from Lothian HMDS regarding ongoing issues with NPM1 MRD. Lothian are actively troubleshooting their assay and reviewing past results.
All patient samples referred to Laboratory Genetics in Glasgow are being directed to Synnovis/Guy’s Hospital Laboratory for NPM1 MRD analysis until further notice. We will provide further updates as available (05/02/26).
Sending a sample for Genetic testing
Each request accepted by the laboratory for testing is considered an agreement between the user and laboratory. Please see the Terms and Conditions of Service
Sample acceptance criteria / mandatory information
Either a completed request form or a detailed letter must be sent with each patient sample. Forms can also be requested by telephoning the department on 0141 354 9300 or downloaded from the list using ‘Request Forms (Germline and Somatic)’ tab below.
As a minimum, two pieces of patient identifying information must be provided on both the form and the sample container, e.g. name and CHI number. Specimens may be rejected if the form and the sample container do not have the same 2 patient identifiers.
Consent for testing
Discussions regarding testing and/or storage of genetic material is the responsibility of the referring clinician and a summary of clinical consent will be included in the patient’s health record. Consent is implied by submitting the sample for testing to the laboratory.
Further Analysis on Previously Stored Sample
For clinical users that wish to request further genetic testing for patients where we already have an appropriate specimen in the laboratory, the Further Analysis Request Form needs to be filled in. This will automatically send the request to the genetics laboratory. The request will be actioned by the laboratory or someone from the laboratory will contact the referring clinician if there are any issues or if further information is required.
Accreditation and Quality Management
The Laboratory Genetics department is accredited by the United Kingdom Accreditation Service (UKAS) to ISO 15189 standards. The scope of accredited services are listed within our UKAS schedule of accreditation.
As part of our quality management system and to ensure that we are meeting the needs of our users, we are always keen to receive any comments you may have regarding the quality of the service we provide and would welcome any suggestions on ways in which we might be able to improve the service. If you are not satisfied with any aspect of the service, please contact the Quality Manager.
Haemato-oncology send away tests – all referrals for specialist testing must be sent via Laboratory Genetics for processing and forwarding to appropriate test centre
Laboratory Genetics forms part of the West of Scotland Centre for Genomic Medicine and is co-located with the Clinical Genetics Service at the Queen Elizabeth University Hospital in Glasgow. The Laboratory provides a comprehensive diagnostic genetic service for the patients of the West of Scotland (population >2.7 million) and offers specialised testing to the whole of Scotland, the UK and overseas.
The laboratory is a member of the Scottish Strategic Network for Genomic Medicine, with laboratories also located in Aberdeen, Dundee and Edinburgh. The Laboratory Services are funded by National Services Division of NHS Scotland (NSD) and are commissioned to work together to provide a comprehensive genetics service to the patients of Scotland.
The Laboratory Genetics department is accredited by the United Kingdom Accreditation Service (UKAS) to ISO 15189 standards. For more information see Accreditation and Quality Management section under Information for Service Users.
More Information
Our Services
The department offers Germline and Somatic testing, full details of which can be found under the Information for Service Users link.
For Clinical Genetics please call 0141 354 9200 (internal 59200)
Opening Hours
Monday to Friday, from 8.30am – 5.00pm
The laboratory does not offer an out of hours service but it may be possible to arrange the analysis of urgent samples out with these times, by prior arrangement. The department is closed during public holidays.
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Palliative Care Definition
This framework sets out a vision for the next five years, outcomes and ten commitments to support improvements in the delivery of palliative and end of life care across Scotland. It will give an understanding of the definition of Palliative care and the link to preferred place of death.
Whilst Anticipatory Care Planning may be particularly useful for people receiving palliative care, it is a tool that can be used with anyone. Staff should encourage everyone to start to think about what matters to them and what their wishes and preferences may be. More information and resources to help guide conversations can be found on the ACP Resources Page.
As part of the GGC Unscheduled Care Anticipatory Care Programme, a standard operating procedure has now been published giving detailed guidance to staff regarding the process of having and recording anticipatory care planning conversations. This guidance is applicable across all areas of NHSGGC, including the 6 HSCPs, Primary Care, Acute settings and the independent care sector.
The SOP is very comprehensive with a quick guide to support navigation. These can be accessed via the ACP Resources Page or via the links below:
We hope existing and newly recruited staff, managers, GPs and Nursing/Care Homes will find the SOP helpfully provides guidance around ACP conversation initiation, use of the ACP Summary document, saving to Clinical Portal and KIS. Example ACP Summaries are also included providing extra support. All staff can also access ACP training via the emodule or attending a virtual communication skills workshop (dates available on the webpages).
We will be promoting this document over the next month via tweets, core briefs, e-bulletins etc. and would appreciate your help in spreading the word. You can follow us on twitter at @NHSGGC_ACP or forward any emails you receive to colleagues and networks you feel may be interested.
Any feedback or questions regarding the documents or the programme can be sent to ACPSupport@ggc.scot.nhs.uk.
You will need to be logged on to the NHSGGC network to access this content.
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Trainees are expected to build up a portfolio of evidence throughout their 2-year training. We currently use the Turas Professional Portfolio available from NHS Education for Scotland. These are free to nurses working within Scotland.
Trainees will begin to build this early in their training and continually contribute evidence to the Portfolio as they progress through training. For example, evidence of achieving competencies related to prescribing and therapeutics can be added whilst undertaking the prescribing component of your pathway.
Trainees are expected to record the following in their Portfolio:
Personal details including NMC PIN Number.
Learning Plan – the ‘Professional Journal Plan’ in the Portfolio can be used for this purpose.
Record of Learning – All learning activities (these can be grouped into themes e.g. modules completed, eLearning, supervised practice etc)
All supervision sessions
An anonymised list of patients seen (gender, approx age, presenting complaint, diagnosis, management/referral and any key learning points). Trainees may wish to keep this as a spreadsheet or word file and upload into their portfolio periodically. A blank template can be found on the trainee ANP moodle site.
Remember – no patient identifiable information should be kept in your portfolio.
Competencies
Trainees are expected to work through the appropriate competency document and upload a scanned copy to their Portfolio prior to any supervision meetings (relevant competency documents will be given to trainees during the training). The trainee should self-assess and then the Practice Assessor should go through with the trainee. Competencies should be signed as complete when the assessor has seen satisfactory evidence, within the Portfolio, that the competency has been met. Items listed below can contribute towards evidence of competence achievement and should be cross referenced within the Portfolio.
Reflection
Trainees are encouraged to regularly write up anonymised reflective accounts relating to patients they have seen or from appropriate learning situations.
Feedback
Supervisor in Practice Reports. Practice Supervisors are expected to feedback at various points throughout a trainees training using the Generic Feedback form in the Portfolio.
Trainees are expected to get feedback from a variety of different people for components 1-3 described below:
Mini-CEX – Trainees should include a number of mini Clinical Examination assessments in their portfolio. A mini-CEX should be used where a Practice Supervisor gives formal formative feedback to a trainee on a consultation. Forms can be found on the Portfolio and ‘a ticket’ can be raised so the supervisor can complete.
DOPS – Direct Observation of Procedural Skill. Once a trainee has learnt a new procedural skill, the Practice Supervisor should give formal formative feedback using the DOPS form. Forms can be found on the Portfolio and ‘a ticket’ can be raised so the supervisor can complete.
Case Based Discussion – Trainees will discuss numerous cases with their Practice Supervisors. Trainees are encouraged to keep notes on all their significant discussions and to write up formal case based discussions. The Case Based Discussion template within the Portfolio should be used for this.
Multisource feedback (MSF) – Trainees should request feedback from different clinicians (e.g. ANPs and medical staff) and non-clinicians. The generic feedback form in Portfolio can be used and a ‘ticket’ can be raised for the respondent to complete.
Ultimately, the Portfolio will become a central part of the final sign-off process and trainees should familiarise themselves with the requirements for this on the Final Sign-Off area on this web page.
Final Sign Off
Prior to being recorded as an ANP your line manager needs to confirm that you have completed all the required training for the role and have evidence that you meet all the required competencies. This process is termed ‘final sign-off’.
Final sign-off is required when an individual:
Completes initial training
Changes job (especially if it’s in a new speciality)
For final sign-off the ANP trainee should select out the ePortfolio evidence which best demonstrates their learning and competence. The trainee ANP will submit a ‘Share-Pack’ of this evidence to their line manager when they are ready for ‘final sign-off’.
The Final Sign-Off Process
Final Sign-off involves:
The individual’s line manager who will take the lead on the sign-off process
The Practice Supervisor or a nominated Practice Assessor
The Education Institution – this would usually be through evidence of completion of a programme of education (for example a copy of the Postgraduate Diploma in Advanced Practice and/or academic transcript)
STEP 1
The trainee ANP will develop a share pack of evidence within the ePortfolio which meets the requirements of final sign-off.
STEP 2
The tANPs manager sets a date for the tANP to submit the ‘Share Pack’ and shares this with the Practice Assessor. Both would be expected to review the portfolio and confirm it meets the criteria for final sign-off. As a minimum the following is expected:
Record of their learning including clinical experience as a trainee.
A minimum of 400 hours of supervised practice[1] over a minimum of 1 year
Evidence of learning[2] covering the following areas:
Clinical assessment
Clinical reasoning, judgement and diagnostic decision making
Anatomy and physiology
Non-medical prescribing
Leading, delivering and evaluating care
Worked based learning
Completion of all academic requirements (record of all modules undertake, including copies of transcripts to evidence results and a copy of their final exit award certificate).
Copy of a masters level qualification in advanced practice (or evidence of equivalence [this would normally be 120 credits with a minimum of 50% at masters level).
Evidence of being recorded with the NMC as a Nurse Independent Prescriber
Evidence of being recorded with Health Board as a Prescriber
Completed competencies – The competency framework should be completed and mapped to evidence within the ePortfolio.
A range of Work Based Practical Assessments[3] demonstrating competence is managing the broad range of patients seen within the role. This is likely to include:
Mini-CEX (min 6)
DOPS (min 2)
Case Based Discussions (min 10)
Reflective Accounts (min 10)
Evidence that a broad range of patients has been seen (e.g. an anonymised patient log)
Feedback from others (min 4 different people)
Satisfactory Practice Assessor reports which confirm the trainee has completed training and has been assessed as competent performing as an ANP
STEP 3
The Practice Assessor and Line Manager will together determine whether the trainee has:
Passed – Satisfactorily passed all academic requirements and evidence of competence to practice in ANP role contained within ePortfolio.
Provisional pass – satisfactorily passed all academic requirements, but some minor gaps in evidence of competence.
Fail – either has still to pass all academic requirements or has major gaps in evidence of competence or both.
STEP 4
If the trainee has passed, the line manager would complete the final sign off form. The trainee will upload and add this to the share pack and forward the completed share pack to advancedpractice@ggc.scot.nhs.uk for internal moderation.
If the internal moderator agrees that the portfolio meets all of the requirements then the trainee, employed as Band 7 Annex 21 or Band 6, would be expected to move to a Band 7 at this stage.
If a provisional pass by either line manager or internal moderator, the line manager would set a period of time (no less than 1 month and usually no-more than 6 months) for the individual to obtain the required evidence.
Trainees employed as Band 7 Annex 21 or band 6 would not normally move until competence has been achieved.
If a fail, the line manager, in consultation with others (which may include the clinical supervisor, education supervisor and Human Resources) the most appropriate course of action for the individual. This may include re-doing part of the training or termination of the traineeship.
If the Practice Assessor and Line Manager cannot agree on a grade the view of the internal moderator should be sought.
STEP 5
As part of quality assurance, it is current practice in NHSGGC for all share packs submitted for final sign-off to be internally moderated by an Advanced Practice Lecturer Practitioner.
STEP 6
A sample of portfolios will be externally moderated each year via the Advanced Practice Academy. This mechanism will involve a suitable expert from another Board reviewing ePortfolios and providing feedback to the line manager, the Board Advanced Practice Lead and the Board Nurse Director.
External Experts will be recorded within their employing Board as an ANP or NMAHP Consultant and either have teaching and assessing qualification or be recognised by the Academy as an ‘External Expert’.
The Academy’s recommendations will be advisory only. Ultimately it will be for the employer to determine whether an individual has met all the requirements to practice.
[1] Supervised practice may involve direct supervision where the supervisor is physically present with the trainee or indirect where supervision is provided at a distance or delegated to another clinician
[2] This may include formal academic modules/courses, clinical courses, eLearning, reflection
[3] Individual specialist areas may require higher numbers that specified here
Final Sign off documentation
Click here to see the ‘Final Sign-off’ documentation that the line manager and supervisor in practice will use to assess the ePortfolio.
Example of an ePortfolio share pack
Please click on the link below to see a dummy ePortfolio for a trainee ANP. In this portfolio you’ll see evidence being gathered to meet the requirements for final sign-off.
Please note the numbering system and ordering being used to make it easier for a reviewer to find the evidence.
Abbreviations used:
MCEX – mini-CEX
DOPS – Direct Observation of Procedural Skill (DOPS)
Please note this is ePortfolio is provided as a sample and do not scrutinise the evidence provided, it is indicative of whats required.
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