On this page you will find the latest news and up to date information from the N.D.D.H. Pathology Department.
Updated List of Unaccredited Tests – 22nd October 2019
Following our latest accreditation visit by the United Kingdom Accreditation Service in October 2019 we have updated our list of tests which are currently not accredited. To view this list click here.
29th September 2019
Improvements to How you Add On a Test
Following feedback, we have improved the way you can add on extra tests. To add on non-urgent tests to samples stored in the Biochemistry/Haematology/Microbiology laboratories, please use this form, or complete a request form and send it to the laboratory. If the additional test request is still within the time frame for the integrity of the specimen we will re-analyse the specimen.
If it is likely the result will rapidly change patient management, please contact the relevant laboratory directly by phone or bleep.
Changes to Some Biochemistry Test Reference Ranges
Changes to reference ranges for tests offered in the Biochemistry department of North Devon District Hospital were implemented on 23rd May 2019. This was to introduce paediatric specific ranges for tests offered in house. Adult reference ranges are largely unchanged, with two exceptions:
- ALT reference ranges were previously 0-36 (F) and 0-40 (M), they are now 0-33 (F) 0-41 (M)
- Total bilirubin range is presented as ‘<21’ rather than the 0-21 previously used. This is to comply with national guidance.
One change has not been completed yet. The universally applied fasting glucose reference range of 2.5 – 5.8mmol/L was a historical one with no evidence base available. The fasting range for glucose shall be edited on the 12th of June 2019 to the values indicated below
- Paediatric (<18 years): 3.3 – 5.6 mmol/L
- Adult (18+ years): 4.1 – 5.6 mmol/L
Attached is the updated list of reference ranges – those tests highlighted in green are unchanged, those in orange were amended on 23/05/19.
The pathology section on Bob is due to be updated and shall contain this information in the coming weeks.
Should anyone wish to discuss this process, or obtain copies of the references used for evidence, please contact me at email@example.com or at 01271-322419
Mary Stapleton FRCPath
Principal Clinical Biochemist
Northern Devon Healthcare NHS Trust
Raleigh Park, EX31 4JB
Copper, Zinc & Transferrin Saturation Levels during Acute Phase Infection or Inflammation
In the case of an acute phase reaction (infection, inflammation) the concentration of a number of proteins may change – some react by increasing, others by decreasing. A recent audit within the Biochemistry department has indicated that adding CRP to a sample when certain tests are requested may provide value in the interpretation of results.
We have started adding CRP to copper, zinc and transferrin saturation (TFER) requests from 27th March 2019.
Copper and zinc requests shall be forwarded to external laboratories for analysis, regardless of the CRP result. Minor inflammation (<20mg/L) is thought to affect these analytes by approximately 10%. Major inflammation (>100mg/L) may affect results by 30-40% in these analytes.
Transferrin saturation may decrease up to 30% in cases of acute phase reaction – for this reason we are withholding analysis of transferrin saturation in cases where CRP is greater than 50 mg/L. We will retain the sample for 2 months at -20°C. Please contact the laboratory if you wish to discuss analysis of any sample which has been withheld in this manner.
For GP practices, when these tests are ordered in tQuest, the following informative comments will be available prior to ordering
The measurement of iron status may be complicated by the presence of an acute phase response. Ferritin is increased and transferrin decreased in an acute phase response. CRP shall be added to this Transferrin Saturation request to assist in the interpretation of results.
The measurement of copper levels may be complicated by the presence of an acute phase response. CRP shall be added to this request to assist in the interpretation of results.
The measurement of zinc levels may be complicated by the presence of an acute phase response. Please add a CRP to this request to assist in the interpretation of results.
For further information or to discuss any aspect of this bulletin please contact:-
Mary Stapleton FRCPath
Principal Clinical Biochemist
Northern Devon Healthcare NHS Trust
Raleigh Park, EX31 4JB
Increase in Immunoglobulins and Parasite (Concentrate) Test Turnaround Times
Monitoring of test turnaround times (TATs) has identified two tests where the TAT is longer than the current quoted TAT target value. The tests affected are:
Biochemistry – Immunoglobulins. Quoted TAT Target = 4 hours from receipt in the lab. Actual average TAT is 7 to 30 hours. This is due to an intermittent ongoing technical issue that is currently being investigated.
Microbiology – Concentrate (Parasite Examination) Quoted TAT Target = 48 hours from receipt in the lab. Actual average TAT is 54 to 73 hours. This is due to additional staff training being undertaken in the department.
Apologies for any inconvenience this may cause.
Pathology Quality Manager
Northern Devon Healthcare NHS Trust
Biochemistry Dept: Parathyroid Hormone (PTH) Stability in GP Collected Blood Specimens
A review of the pre-analytical phase of the testing process is performed at intervals in the Biochemistry laboratory. This is in order to ensure that the samples we receive for analysis are appropriate and of suitable quality.
Most analytes are robust, with few requiring special treatment. However, analytes such as PTH have limited stability at room temperature.
The half-life of PTH is short (3-5 minutes), and it is advised that blood samples are to be spun in a centrifuge as soon as possible. Stability thereafter is 8 hours at 20-25°C and 2 days at 2-8°C. Stability of unspun serum samples is 4 hours.
Primary care facilities have access to centrifuges in order to separate serum from red blood cells and preserve the integrity of the samples being sent for analysis. Recommendation was made at the time of centrifuge install to store any separated samples at 2-8°C until collection by Sodexo.
Currently, it is not possible to review which samples being received for PTH analysis have been spun and stored appropriately prior to receipt. This practice is being addressed.
From the 10th December, we shall be noting whether samples for PTH have arrived spun/unspun on our laboratory information system. PTH results on samples received unspun from primary care may be blocked as a result, and the comment ‘Sample > 1 day old, result NOT available’ reported instead.
Should you have any queries relating to this matter, please do not hesitate to contact me at firstname.lastname@example.org
Mary Stapleton FRCPath
Principal Clinical Biochemist
Northern Devon Healthcare NHS Trust
Biochemistry Dept: Potential Test Interference with Bilirubin and/or Creatinine (13/08/18)
MHRA Notification of Possible Interference
A drug safety update regarding interference with some test results by Eltrombopag has been issued by MHRA [https://www.gov.uk/drug-safety-update/eltrombopag-revolade-reports-of-interference-with-bilirubin-and-creatinine-test-results]
Should bilirubin and/or creatinine laboratory results be inconsistent with clinical observations, you are advised to consider re-testing using another method to determine the validity of the work.
Eltrombopag is highly coloured (reddish-brown), and may cause interference with bilirubin (false low/normal) or creatinine (false high/normal) results. The interference with creatinine may result in a misleading clinical picture of apparent renal deterioration.
The degree of the effect is llikely to be related to the concentration of Eltrobopag, as it is thought the cause is related to the colouration of the serum caused by the medication.
(Eltrombopag is used to treat low platelet levels due to chronic immune thrombocytopenia.)
Biochemistry: Some Immunoassay Tests Results can be Affected by High Doses of Biotin
Principal Clinical Biochemist, Mary Stapleton, describes the implications of how: High doses of Biotin (vitamin B7) can affect some biochemistry assays (tests).
North Devon Pathology Service is Granted UKAS Accreditation (29/03/18)
The Pathology Service at the North Devon District Hospital has been granted accreditation by the United Kingdom Accreditation Service (UKAS) to ISO 15189, ‘Medical Laboratories – Requirements for Quality and Competence.’ This award replaces the previous CPA accreditation which expired at the end of March 2018.
The main difference is that individual laboratory tests are now accredited, rather than the overall laboratory service. As a result of this and due to continuing quality improvements in Pathology, where equipment and tests methods are changed, there are some tests that are waiting for assessment by UKAS. For a list of the tests that are currently not accredited and waiting for assessment by UKAS, click here.
Biochemistry Reference Ranges – Amendments
On 15th March 2018 the Biochemistry Dept. went live with some new analytical equipment. This has meant that reference ranges for some of the tests we report have changed slightly. For a list of the tests where reference ranges have changed please click here.
Note: the tests shown on a pink background indicate the reference range has changed. If you would like more information or have any queries regarding these changes, please contact Mary Stapleton, Principle Clinical Biochemist on 01271 322419 (or ext 2419 from within N.D.D.H.) email@example.com
In May 2017 we issued a satisfaction questionnaire to all Northern Devon Healthcare Trust medically qualified clinicians inviting them to answer various questions about how satisfied they were with the North Devon Pathology Service. The results of that survey have been compiled into a report documenting the responses.
Ascitic Fluid for Cell Count – Change of Specimen Container – 30/03/17
Previously, ascitic fluids for a cell count were collected in a purple top (EDTA) blood tube and sent to the Haematology Dept for testing.
From now on, ascitic fluid samples for cell count should be collected in a sterile 30ml universal container and sent to the Microbiology department with an appropriate (blue/white Microbiology) request form, along with a set of blood culture bottles for culture.
Details of Microbiology specimens and specimen containers can be found here.
Blood Coagulation Results – Change to Reference Ranges from 09/02/17
With effect from Thursday February 9th 2017 we are changing our blood coagulation analysers. This will affect reference ranges as detailed below.
The most clinically significant change is that for the DVT cut-off which will be a D Dimer level of 0.25 as opposed to 0.22 mg/L.
Coagulation results issued from approximately 09:30 on 09/02/17 will include the new reference ranges and a laboratory comment informing users that reference ranges have changed.
Reference ranges for haematology tests can be found in the Haematology A-Z List of Assays
Latest – New Edition of Pathology Newsletter Published – Posted 10th January 2017
Click here to view edition 13 of the newsletter and access past editions.
New blood culture bottles have been put into use today (19th May 2016). The old bottles should no longer be used as they are not compatable with our new blood culture analyser.
A representative from BD – the company that supplies the bottles – will be out and about in NDDH locations today training users in the use of the new bottles.
If you have any queries relating to this change, please don’t hesitate to contact the Microbiology Department in Pathology on ext. 2347 (322347 from outside the hospital).
For full information on how to collect blood cultures, the equipment required and a poster visually explaining the process, please click here.
The Histopathology and Non-Gynae pages of the Pathology Handbook have been completely re-written and updated. Non-Gynae Cytology now has it’s own separate section with much more detail on the correct methods od specimen collection and preservation.
The Pathology Blood Sample Collection Guide has been updated. Current version is 3.1. Hardcopy versions have been issued to Outpatients A & C areas. Refer to this document for a Pathology-wide list of blood tests with information on which blood tube to use, how many tubes are required and any other special instructions relevant to each test.
Please take a moment to answer our one-question survey on how satisfied you are with the Pathology Service. There really is only one question!
For the attention of all Clinicians who order blood tests – change in procedure
Please note that with effect from Monday 1 September, to comply with NICE guidance (clinical guidance 182 Chronic Kidney Disease), the calculation used for Estimated Glomerular Filtration Rate (eGFR) will be changing when reported in the renal profile.
For further guidance on comparing the ‘old’ result with the new, please use the online calculator on http://mdrd.com/.
Please note that eGFR should only be used for patients with a history of stable creatinine levels over the previous 90 days.
Andy Lansdell, Principal Clinical Biochemist (01271 322419)
Tim Watts, Laboratory Manager Blood Sciences (01271 370232)
24th June 2014
Glycated Hb A1c Assay at NDDH – Some changes
Following a recent procurement exercise, we are changing methodology for measuring glycated haemoglobin A1c with effect from Thursday June 26th.
The change will be transparent to you, but we will be changing the wording of the interpretive guidance (sent out as laboratory comments) with each result. This new guidance will read as follows:
“For the diagnosis of Diabetes in ASYMPTOMATIC patients,
a first HbA1c >=48 mmol/mol Hb should be confirmed with
a second sample collected within 2 weeks. If the second
result is lower than 48 use this value in preference,
categorise the patient as high risk and repeat the test
in 1 year. For monitoring, a minimum of 30 days for
repeat testing is recommended.”
This procurement has been Peninsula-wide so is a step towards one of the Commissioner goals of standardised testing across the whole area. It will also allow us to perform a burgeoning workload more efficiently.
The interpretation above is that used by the Royal Devon & Exeter Hospital and is appropriate for the new methodology. If you require any further information, please contact Tim Watts on 01271 370232 or firstname.lastname@example.org
***RESOLVED*** Delay in Reporting some Pathology Results
One of the analysers in the laboratory has suffered a breakdown and as a result there will be a delay in reporting certain test results to Pathology Service Users. Tests affected are as follows:-
TSH, fT4, fT3, anti-thyroid antibodies, B12, folate & ferritin, FSH, LH, prolactin, progesterone, oestradiol, PSA and CEA.
What we are doing to fix the problem:-
The analyser first failed on Friday 9th May. An engineer was called and we were informed it would be fixed on Monday 12th May. However, the fix was achieved on Tuesday and we then attempted to catch up with the back-log.
Unfortunately, the same fault reoccurred on Thursday 15th and the engineer is still working on the problem.
Estimated Time to Resumption of Normal Service:-
We are sorry for the delay in processing samples for the stated tests and are doing everything possible to get the matter resolved as soon as possible. Once a repair has been successful, it will take us 3 – 5 days to catch up and clear the backlog of outstanding tests.
We will inform you when the problem has been rectified, thank you for your patience.
Electronic Requesting of Pathology Tests Goes Live at Fremington Medical Centre
Pathology order communications system (Order Comms) for Primary care went live at Fremington medical centre yesterday. This computer system integrates the GP practice and Pathology clinical computer systems and allows staff in GP practices to electronically request most pathology tests from their computer screens without the requirement to handwrite a pathology request form. These electronic requests are transmitted to the pathology computer system and the request is linked up to the specimens when they arrive in the laboratory by the use of unique barcoded labels.This is a culmination of a significant amount of work and a very successful partnership with primary and secondary care (and our supplier) to establish a system that we expect will bring many benefits from a patient safety, quality, efficiency and cost saving perspective.This system now provides a valuable tool to help drive standardisation and patient pathway management and builds upon the very strong and effective clinical relationships that have been developed between primary and secondary care over the past few years.Particular mention/thanks should go to the core Pathology team of Tim Watts, Rob Stradling and John Soukal Neil Schofield and Sam Maurice (I.T.) who have been instrumental in its delivery and implementation.Three other pilot sites of Brannam, Northam and East Street will follow Fremington shortly. The go live dates for the remaining North Devon GP practices will then be scheduled.
Latest Pathology Newsletter (Testing Times) is Published
Click here to view edition 11 (October 2013) of the newsletter and access past editions.
Pathology Users Survey Results Published
Results of the latest Pathology Users Satisfaction Survey have been published. The report includes comments and responses to all issues raised by NDHT pathology users.
Microbiological Analysis of Urine Specimens
The way we analyse urine specimens is improving, this means there will be a few changes to the way we report these results:-
Summary of changes to urinalysis from 26th September 2013:-
1. Quality Improvement For Patients – To prevent over treatment of asymptomatic bacteriuria we are introducing a new rejection criteria for urine specimens.
- All urine request forms that do not include clinical details or only state the dip analysis results will be held back to give requesting clinicians the opportunity to provide relevant clinical details and confirm there is a need for examination.
- We will issue a report requesting clinical details and retain the specimens for 48 hours.
- Click here to view the user consultation document from Dr Tom Lewis, Consultant Medical Microbiologist.
2. Quality Improvement of the Urine Analysis Process – Automated flow cytometry will no longer be performed as we have found there is improved quality of analysis by using the traditional manual method.
- This means that negative urine results will no longer be reported on the day of collection; however, manual inverted microscopy will be used to quantify white blood cells in the same 4 bandings provided by the automated process.
- Epithelial cells and bacteria will no longer be reported and casts can be requested (if appropriate) as before.
3. Quality Improvement – in the Content of Reports – All urines will now be cultured so there will be a slight increase in the turnaround times of negative urines. However, improved direct sensitivity testing will allow more timely reporting of urines with positive cultures with a reduced amount of reported antibiotics made available.
If you have any further queries regarding these changes, please contact Dr Tom Lewis, Consultant medical Microbiologist on ext. 2384 (direct dial 01271 322384) or Colin Parkin, Microbiology Laboratory Manager on ext. 3278 (direct dial 01271 370278).
Lactate levels can now be determined using a blood gas sample on the ABL90 Flex blood gas analyser in Biochemistry. As with all blood gas samples, samples should be sent immediately (within 20 minutes) to Biochemistry with a request form detailing appropriate clinical information and where/whom to phone/bleep results.
The current method for lactate estimation – collection of blood sample in a grey topped fluoride tube sent immediately (within 20 minutes) to Biochemistry for analysis, will continue to be available at least until the end of August.
Take the latest Pathology Users’ Satisfaction Survey. Click here to be able to access a printable copy of the questionnaire.
15th January 2013
Two new Blood Transfusion pages have been added to the Pathology Handbook. Use the menu on the right hand side, or click here to access them.
24th December 2012
Latest pathology newsletter (Testing Times), edition 10, is published.
27th June 2012
Andrology Specimen Collection Guide – Updated
3rd January 2012
Microbiology Specimen Collection Guide – Update
3rd January 2012
Latest edition of the Pathology Newsletter – Testing Times published (edition 8). Click here to access the Testing Times page.
2nd December 2011
NEW! Interpretative & Clinical Advice Email Service
Many phone calls to Pathology clinicians from GPs or other health care professionals in the community are for non-urgent queries.
Although we are always available to take calls, there are often issues getting through switchboard and then tracking down the right person. If we are engaged doing something else then it may be hard to deal with the call in a timely fashion. There may also be difficulties in accessing the necessary information in order to give accurate advice if we away from the laboratory. If a message has been left for us to call back, then it can sometimes be difficult for us to get through at a convenient time.
In an attempt to improve the current situation, following feedback from our GP colleagues, we have created a generic Pathology e-mail to which all non-urgent clinical queries can be sent.
This can be used for all pathology related queries (biochemistry, haematology, microbiology, histopathology). This will be checked at least daily and you can expect a response within 24 hours. The address is ndht.Pathologynddh@nhs.net
We will, of course, remain available for telephone advice at all times, but hope that you will see this as a useful alternative means of contact.
Dr Tom Lewis, Consultant Medical Microbiologist
18th August 2011
Blood Culture Specimen Collection Guidance – UPDATED
Collection of blood culture specimens by the ‘winged’ blood collection method has been updated. Click here to see this information.
13th July 2011
New Pathology Specimen Reception & Office Area – Now Open!
The building work has now finished and the new Pathology Specimen Reception area is now being used. Specimens are delivered through the new hatch during office hours (09:00 – 17:30) Outside these times, specimens should be delivered through the new main Pathology doors (via I.D. swipe card access), and placed on the large square specimen tables.
If you feel you should have I.D. swipe card access to the main Pathology doors, please contact Tim Watts on ext. 3232 (or 01271 370232 from outside the NDDH), or email email@example.com
Redesigned Biochemistry & Haematology Request Form
Have your say! We would like to hear your opinions on the first draft of our new-look Biochemistry & Haematology request form.
Have a look and please feel able to make any constructive comments to the Pathology Quality Manager, firstname.lastname@example.org .
Each request form will be a single A5 sheet (not duplicate as at present) and come with an attached specimen bag for ease of use.
Click on the link to view the design of the form.
16th June 2011
Redevelopment of Pathology Specimen Reception & Office Area
The ‘front end’ of the Pathology Dept is currently in theprocess of being redeveloped and upgraded to provide a modern, efficient environment which will help us to improve efficiency and quality of service to Pathology Users.
Whilst the building work is in progress, please be careful on the approach to the laboratory, and follow any temporary signs which may be in place.
The blood bank has already been relocated to it’s new home – against the wall, on the right as you approach the laboratory.
All other deliveries – specimens and post – are currently being taken into the main lab for processing.
We hope that the work will be completed during the first week in July.
6th June 2011
Group Microbiology Contact E-Mail Address Now In Use
The NDDH Consultant Medical Microbiologists recognise that it can sometimes be difficult to find a consultant microbiologist to discuss some relatively simple issues. We have set up a group e-mail which can be used to make simple, non-urgent requests – e.g.. release of different antibiotic sensitivities or junior doctors could e-mail before lunch of the patients they would like us to see on an afternoon ward round, with some brief clinical details.
We will review these each day, and can re-issue amended reports or perform additional tests as necessary. The address is:
This service began on 16th May 2011.
NOTE: If printed, information on this page is only valid on day of printing.