Department of Cellular Pathology

Andrology

The laboratory's priority is to provide a comprehensive semen analysis service for Consultants, Urologists and General Practitioners from the Birmingham and Solihull area. This includes semen analysis (Diagnostic Semen Analysis), post-operative analysis of semen following a vasectomy operation (Post Vasectomy Semen Analysis) and Retrograde analysis of urine.

The laboratory operates on a clinic based service and has a maximum capacity of 2000 appointments available per annum. This covers the annual workload of routine diagnostic semen analysis, post-vasectomy samples and retrograde ejaculation analysis. Routinely patients will be given an appointment to attend the Andrology Department for on-site sample production in a designated private clinic room, however in exceptional circumstances samples may be produced off site if then able to be delivered to the laboratory within an appropriate time interval. 

The UHB Andrology Laboratory has fully trained scientists who are highly proficient in performing quality diagnostic semen analysis in line with World Health Organisation (2021) and the 2016 Laboratory Guidelines for post vasectomy semen analysis. The laboratory regularly performs internal quality control, participates in the UK National External Quality Assurance Reproductive scheme for Andrology (UKNEQAS) and liaises with other accredited laboratories for comparison of tests not covered within the UKNEQAS scope.

A laboratory referral can be made via:

• Paper copy referral forms sent to Appointment Centre via post/e-mail
• Electronic Referral Service (e-RS) with an attached referral form 

A copy of the referral form can be obtained by;

• Contacting the laboratory directly on 0121 424 9717 Or by accessing the word version at:
  Andrology referrals

Off-site production can be arranged by the patient by telephoning the laboratory on 0121 424 9717 or by e-mailing This email address is being protected from spambots. You need JavaScript enabled to view it. (if you e-mail you are accepting that the connection is not secure and potentially not confidential – laboratory staff will minimise data transmission but cannot guarantee security). Please note that retrograde urine production must be on-site at Good Hope Hospital.

Turnaround Time: 7-10 days (electronic reporting may be more rapid). Paper copies sent out following result authorisation.

Anti-sperm antibodies (ASAB) are not tested at this laboratory. Agglutination is described if noted.

Accreditation information can be found under Cellular Pathology (UKAS 10141):
https://www.ukas.com/download-schedule/10141/Medical/

Post-vasectomy Semen Analysis (PVSA)

The laboratory undertakes examination procedures in line with the following guidelines: 2016 PVSA Guidelines. This will give clinicians information regarding clearance criteria. 

Results are available to Hospital clinicians via PICS, Clinical Portal, and ICE.

GP’s can access patient results through their own electronic result systems.

Key details of the service:

• Operates Monday to Friday 08:00am to 16:00pm
• Undertakes Diagnostic semen analysis, Post vasectomy semen analysis and Retrograde examination (urine)
• Appointment based with on-site private room for sample production
• 7-10 day turnaround time (electronic and paper copy reporting)
• Patients are booked within 7 weeks from referral, unless clinically indicated or by patient choice

Please see user handbook for additional information including contact details:
Andrology User Handbook 

Andrology - Measurement Uncertainty

Following on from our recent UKAS assessment, we were advised that we need to demonstrate that the clinical impact of the Measurement of Uncertainty on clinical decision values has been assessed and considered in relation to patient outcome. This must include an explanation of any effects this could have to the decision limits and how they should be interpreted.

Diagnostic Semen Analysis

Application of the Coefficient of Variation (CV) to the Clinical Relevance of Diagnostic Semen Analysis (DSA)

The Coefficient of Variation (CV) was calculated for each Diagnostic Semen Analysis (DSA) parameter and used as a measure of the associated analytical uncertainty. The CV values were derived from internal quality control (IQC) data collected over the previous 12 months. The calculated CVs are summarised below:

Uncertainty is calculated by dividing the analysis result by 100 and multiplying by the associated CV. The measurement range is then expressed as the reported result ± the calculated uncertainty.

The potential clinical impact of measurement uncertainty is particularly relevant for results that fall close to clinical decision thresholds. The table below provides examples using the CV values above.

Understanding and communicating these uncertainties is essential when interpreting results near diagnostic cut-offs, as they may influence clinical decisions within the fertility pathway.

The clinical relevance of measurement uncertainty will be communicated to service users annually via website updates. Internal users (fertility and urology teams) will be informed directly by email.

 Post Vasectomy Semen Analysis

To ensure compliance with the clearance levels of the 2016 post vasectomy guidelines (<100, 000 sperm/ml) the laboratory have ensured that sperm can be detected in samples that contain 876.9 sperm/ml (as ascertained through multiple dilutions).

 Retrograde Analysis

Retrograde samples have multiple factors that can influence the uncertainty of the results. The laboratory has established a limit of detection for sperm of 175.4 sperm/ml.

Clinical Impact of Measurement Uncertainty

Measurement uncertainty, either for one reported parameter or as a combination of multiple reported parameters could have a clinical impact. For example, if a concentration of 15 x 10⁶/ml is reported (oligozoospermia), given a UoM of 1.4 x 10⁶/ml, this sample could have a concentration of 16 x 10⁶/ml (normozoospermia).

For some users, a diagnosis of oligozoospermia, even at the borderline level of 15 x 10⁶/ml, could lead to the recommendation of an assisted reproductive technology such as intracytoplasmic sperm injection (ICSI) to promote the chance of fertilisation, when conventional IVF, or even natural conception, might be possible. 

We inform our users of this uncertainty and emphasize that the reports can be used to guide clinicians to determine how to proceed with further investigation and management of a subfertile couple. We stress that all reported parameters should be considered holistically.

Furthermore, as per WHO 2021 guidance, we inform users that many known and unknown female factors hamper the value of using only semen examination parameters to predict the prognosis for the couple of spontaneous or assisted fertilization.

The decision limits that we provide on our reports are derived from WHO 2021 and are derived from data characterizing the semen characteristics of a reference population (men whose partners had a time to pregnancy of 12 months or less). The data uses a diverse international populations, noting that the percentiles used do not represent distinct limits between fertile and subfertile men.

We highlight that a semen analysis is never prognostic of fertility, as it is the fertility potential of the couple that defines them as fertile or subfertile.

Cytopathology

The Department provides the diagnostic cytopathology services for the Trust including fine needle aspirations, endoscopic brushings and washings, EUS-FNAs , serous fluids urines and CSF.  Routine specimens should reach the laboratory before 16:30 so that they can be processed within normal working hours. Specimens collected out of laboratory hours should be stored refrigerated until the next morning on which the laboratory is open.  Cytology sample that do not meet the minimum data requirements on request form or sample, are processed, to ensure that sample integrate is maintained. Details of missing data are added to the report.  Request for Consumables and Request Forms

Sample containers for use in cytology and request forms can be order by contacting the Cytology Department; they can be collected from the Cellular Pathology reception at Heatlands or QEHB sites.  Cytology samples which do not meet the MDS will not be returned.  They will be processed in order to preserve the diagnostic material while attempts are made to contact the sender.  These samples will not be reported until adequate labelling of specimen and request form has been undertaken.Minimal delay between collection and receipt by the laboratory is necessary in order to prevent degeneration of cellular components and consequent loss of diagnostic value. All cytological specimens are potentially biohazardous and must be transported in leak proof containers enclosed in sealed bags. Specimens sent to the laboratory via the SDS should be placed in specimen bags and lids on the all containers should be securely closed. 

Specimens from patients with known or suspected tuberculosis, HIV, viral hepatitis or other transmissible disease should be labelled clearly.  Cytology DO NOT except or handle any specimens that are ? prion disease or CJD.

Specimens should be received as either pre-prepared slides, fresh unfixed samples in white- topped universal containers, or suspended in CRR.  Equipment used to collect the specimen such as brushes or drains are inappropriate.

Sputum - A series of three early morning ‘deep cough’ specimens should be collected on three consecutive days for maximum sensitivity. Post physiotherapy and post bronchoscopy specimens are suitable but should be clearly identified as such.

Serous Fluids - 50mls or the whole volume if less is aspirated should be sent in sterile universal containers. Include any tissue fragments or clots. Do not add fixative of anticoagulant. Drain bags are not suitable for transporting specimens and should NOT be sent.

Cerebrospinal Fluid (CSF) - Rapid processing is essential to preserve cells in CSF. These specimens should be sent to the laboratory within one hour.  ALL CSF SPECIMENS SHOULD REACH THE LABORATORY BY 16:30 AT THE LATEST TO ALLOW PREPARATION.

Urine - A representative aliquot of a maximum of 25ml of urine is sufficient for cytology processing, Ensure that this is not the first sample of the day.  Catheter urine and bladder washings are also acceptable but please mention this on the request form. Mid-stream urine samples are not suitable for cytology because they contain few cells.

Endoscopic Brushing - Immediate fixation is important and all slides must be labelled with PENCIL with the patient’s name and hospital number before the smears are made.

Fine needle aspiration - Unless the clinician is experienced in this procedure, including making good quality smears, it is recommended that they contact the laboratory for advice before beginning the procedure. Smears should be made and the needle rinsed out in cytorich red fluid. For ENT specimens in particular it is important that smears are sent as well as needle washings. Only prepared smears and needle washings are accepted. The sending of needles sheathed or otherwise is strictly forbidden.

EUS-FNAs - Please send all the specimen in cytorich red fluid

Cervical Smears - Cervical smears are NOT accepted in nor prepared by cytopathology at QEHB. Please send any cervical smear specimens to the Cytopathology Laboratory at Wolverhampton's Black Country Partnership Laboratories.

Bronchoalveolar lavage sample for differential cell count (DCC)
Bronchoalveloar lavage samples must be collected into a sterile labelled universal container packed with ice packs and transported immediately to the laboratory for preparation to prevent cellular degeneration. Please ensure that the sample is received in the laboratory by 16:30 so a member of staff is available to process it. The labelled sample must be placed in the sealed compartment of a transparent specimen bag and the completed request form placed in the outer pocket. The sample should then be packed between ice packs and delivered to the Pathology department in an insulated transport box.

Sputum sample for differential cell count (DCC)
Sputum samples must be collected into a sterile labelled universal container packed with icepacks and transported immediately to the laboratory (Birmingham Heartlands hospital) for preparation, to prevent cellular degeneration. Please ensure that the laboratory has been informed prior to sending the sample to ensure trained BMS are available to process the sample immediately, on receipt. The labelled sample must be placed in the sealed compartment of a transparent specimen bag and the completed request form placed in the outer pocket. The sample should then be packed between ice packs and delivered to the Pathology department in an insulated Labcold transport box.

Electron Microscopy Service - specific requirements

The Electron Microscope Unit is used routinely at magnifications of between 1500 and 70,000 times to examine the ultrastructure of cells and their surroundings.  The EM unit receives approx. 800 samples a year, the majority of which are renal, but about 100 muscle and 30 nerve biopsies are also collected.  Other specimens include cardiac biopsies, occasional skin biopsies and tumour samples.

Specimens from outside the department requiring EM should be sent in a small sample container (e.g. bijou or Eppendorf tube) containing at least 2 mL of an EM fixative.  A glutaraldehyde based fixative such as 2.5% glutaraldehyde in phosphate buffer is ideal but 10% buffered formalin is also acceptable.  In larger tissue samples individual pieces should be no larger than 3 mm cubed and should be completely submersed in fixative.  The optimal size of diagnostic tissue requiring processing for electron microscopy is as follows: the largest dimension should be no greater than 5mm and the smallest dimension no less than 1mm. Any specimen with the smallest dimension less than 1mm may not survive tissue processing.

For QEHB service users - Renal biopsies are delivered to the Cellular Pathology Specimen Reception and EM samples are taken in the EM Lab. 

For External service users - package specimens for EM in firmly closed leak proof containers, together with sufficient absorbent material to contain any liquid, in sealed bags. The sealed bags are placed securely in a small padded envelope with the address label as given above under key information.  The EM unit makes use of the Histology request form for both internal and external users.   A copy of the light microscopy report is also required.  

Please note that we support the service by outsourcing when required to the specialist EM facility at Leicester Royal Infirmary.  It is fully accredited by United Kingdom Accreditation Services (UKAS) ISO 15189, reference number 8608.

Advice on the service or requirements can be obtained from the EM lead biomedical scientist This email address is being protected from spambots. You need JavaScript enabled to view it. or from the electron microscopy laboratory team on 0121 371 5720.

Muscle Biopsy Service - specific requirements

Muscle biopsies are performed as part of the investigation of a clinically suspected neuromuscular disorder when other less invasive tests have not provided a firm diagnosis.  The Muscle Biopsy Service receives muscle and nerve samples from the whole of the West Midlands region and occasionally from elsewhere in the UK.

This Department offers the following investigative techniques:

• Muscle Histochemistry methods on frozen sections
• Muscle immunocytochemistry on frozen sections.
• Electron Microscopy.
• Histology and Muscle immunocytochemistry on paraffin wax sections.
• Arrangements can be made to send tissue away for DNA analysis.

 If required samples can be referred to specialist centres for further investigation

• Metabolic tests.
• Mitochondrial Assays and MtDNA.
• Protein analysis for adult Limb Girdle Muscular Dystrophies.
• Rare paediatric dystrophies

If a member of the muscle biopsy team is required to collect a nerve or muscle biopsy from QEHB theatres there should be a delay of no longer than 30 minutes between the biopsy being taken and the sample are being placed into fixative for electron microscopy.

For QEHB service users - Please call the lab to request collection as soon as possible once the specimen is available.  Prior to collection muscle should be kept in a dry universal container on water ice (ice can be supplied by the Muscle Lab) and the nerve should be kept in a dry universal container at room temperature.  A copy of the Muscle Biopsy request form noting the time the biopsy was taken should be completed by the requesting clinician. 

For external service users - Medical or secretarial staff from the requesting centre liaises directly with the Muscle Lab to book a biopsy.   A Senior Biomedical Scientist will travel to the hospital to collect the biopsy which is received fresh.  Clinical details are preferably received in advance of the biopsy from the requesting medical staff but relevant information may be transcribed from the patient’s notes onto the Muscle Biopsy Request Form by the Scientist collecting the biopsy.  The Scientist decides which tests will be required on the basis of this information.  The biopsy is cut up and fixed for certain tests on site, the rest of the specimen is brought back to the lab on ice and some is frozen in liquid nitrogen and the remainder allocated for further tests. 

Muscle Biopsy Service :

Cases can be requested as urgent at the time of the biopsy or by email/telephone; the pathologist will relay results back to the clinician via email/telephone.  

• Muscle report  – 4 weeks from receipt to report authorisation.
• Nerve reports – 4 weeks from receipt to report authorisation.
• The current turnaround time for cases referred by the Department to specialist centres is 2-3 months depending on tests requested.

Cellular Pathology is based across UHB sites at QE Hospital Birmingham, at Birmingham Heartlands Hospital, Solihull Hospital and at Good Hope Hospital.

The majority but not all of Cellular Pathology tests that are performed and equipment in use are accredited to internationally recognised standards for medical laboratories ISO 15189.  This is important for the Department and for service users as it provides assurance on quality and competence.   There is increasingly an integrated approach across  the different UHB hospital sites where staff, equipment and testing may be shared to deliver the highest possible quality services to our service users. The full range and nature of accredited tests is detailed on the United Kingdom Accreditation Service website https://www.ukas.com 10141 Schedule of Accreditation .

The Department is currently supporting the Trust with significant increases in clinical activity.  For some specialties reporting times have fallen bellow targets and so the Department is working with service users to minimise the impact of this.  The Department is prioritising clinically urgent requests and patients on cancer pathways, recruiting and working additional sessions.  The Department is also outsourcing reporting of some requests to two external specialist UKAS Accredited suppliers that hold contracts with the Trust.

Specialist Services  within Cellular Pathology (by site), QE=Queen Elizabeth, BHH=Birmingham Heartlands, SH = Solihull, GH=Good Hope

• MOHS (QE, SH) -   microscopically controlled surgery used to treat common types of skin cancer. 
• Neuropathological Smears (QE) -  rapid diagnostic service for intra-operative brain tissue specimens
• Cytopathology (BHH,QE) - diagnostic cytopathology services for the Trust including fine needle aspirations, endoscopic brushings and washings, EUS-FNAs , serous fluids urines and CSF.  
• Muscle Biopsy Service (QE) -  part of the investigation of a clinically suspected neuromuscular disorder when other less invasive tests have not provided a firm diagnosis.
• Electron Microscopy (QE) - used routinely at magnifications of between 1500 and 70,000 times to examine the ultrastructure of cells and their surroundings.   
• Andrology (GHH) - Diagnostic, Post Vasectomy and Retrograde  Semen analysis .  The service operates from a single site located on the 1st Floor of the Sheldon Unit at Good Hope Hospital.
• Direct Immunofluorescence (BHH and QE) - Direct immunofluorescence is used for the detection of  tissue bound proteins such as antibodies and complement proteins. Two types of tissue, skin or renal, are processed, This method allows for the detection of tissue bound antibodies when there may be insufficient levels to detect in serum.  
• Mortuary (QE, BHH, SH, GH) - Body storage available on all sites with 10 freezer storage spaces available on the Solihull sites and 16 on the QE site.  Post Mortems can be carried out on the Heartlands and QE sites.    
• Immunohistochemistry (QE, BHH) - carried out using different platforms and antibodies across the sites.  See attached UKAS scope for those antibodies accredited.  At present there are a few antibodies that are not yet accredited but will be added to the scope in due course.      

Minimum Dataset required for Cellular Pathology Requests

In order to process specimens it is essential that request forms are fully completed in a clear and legible format. The use of patient ID stickers is permitted however please ensure you use the full patient sticker NOT the smaller blood tube sticker. All specimens received into Cellular Pathology must meet the agreed laboratory minimum dataset; any specimens not meeting the criteria will be returned to the requesting department.  Please ensure that any important information (e.g. clinical history, bleep number etc.) is clearly indicated on the form and ensure that any priority or urgent cases are marked as such.

• Trust users can make request via a theatre request book entry or by completing an internal UHB histopathology / cytopathology request form. 
• GP and dental practices should complete the external request form which can be supplied on request from the Department and for internal service users this link http://www.uhb.nhs.uk/gps/laboratory-information/ shows this request form together with specific request forms used within the Trust (QE site)  for liver and breast biopsy cases.  For Heartlands, Good Hope and Solihull users then request forms are available from the Department of via a request to This email address is being protected from spambots. You need JavaScript enabled to view it. 

TWO unique patient identifiers must be present on both the request form and specimen container i.e. a minimum of the PID, NHS number or the DOB together with the patient surname and forename/initial in order to be accepted by the department. Other missing data (e.g. full clinical details) may be clarified over the phone or by email as needed.

Sample pot requirements                                   

• Patients full name  (or as a minimum; surname with initial) 

• Hospital or clinic PID / NHS no. AND/OR Date of birth

Request form                                              

• Patient’s full name.                                 

• Date of birth.                                             

• Hospital or clinic PID / NHS no.

• Address

• Location

• Clinical details

• Request form must be signed

• Consultant / GP

If one or more than one specimen is taken from the same patient the specimen containers and request form must be clearly labelled with the sites of the spec and indicated as parts 1,2,3 etc.

Hazardous Specimens

Specimens arising from patients with known or suspected transmissible diseases (e.g. tuberculosis, viral hepatitis, HIV) must be clearly labelled as such to prevent unnecessary risk to laboratory staff.

Specimen Containers 

When requesting stock a member of staff from the Cellular Pathology department will inform the requestor when they will be ready for collection by the portering staff. Consumables provided by the lab should be transported via the porters so please allow time for preparation and transport.   External requests for sample pots and request forms are through contacting the Department.  For Heartlands site please e-mail This email address is being protected from spambots. You need JavaScript enabled to view it., for QE site use This email address is being protected from spambots. You need JavaScript enabled to view it..

Transportation of Specimens

Specimens are collected at regular intervals from theatres and all relevant departments via portering services. Urgent and unfixed (dry/not in formalin) specimens should NOT be left until the next routine collection – telephone portering services and arrange for a member of staff to bring the sample(s) to the laboratory without delay.

Please note specimens must be despatched to the Department within a secondary bag or secure transport box with sufficient absorbent material to absorb/contain any potential spillage.  Formalin is a hazardous reagent with any leakages put portering, transport and laboratory staff at significant risk.  Please ensure containers are closed or sealed with appropriate fitting lids.  If in doubt please seek advice from the Department.

Urgent Reporting

Occasionally it may be necessary for a requesting clinician to highlight a specimen as clinically urgent. If an urgent report is required it should be clearly identified or indicated on the request form. Urgent requests should be sent to Cellular Pathology via the porters without delay.

To ensure that cases are not delayed within the laboratory please make sure that the request form is correctly completed and all sections are filled in properly. Once received urgent cases will be highlighted by the specimen reception and prioritised appropriately in the departmental workload.  

In addition to clinically urgent cases there are UHB wide @FDS@ or Faster Diagnosis Specification stamps to fast track these patient cancer samples.  This is to support end to pathways and prevent patient breaches where possible through prioritisation.

Service Background

The Department of Cellular Pathology provides a diagnostic histopathology, cytopathology, andrology, muscle biopsy, electron microscopy, Mohs, post mortem and mortuary service to internal users (other Trust departments e.g. surgery) as well as external users (GPs, dental and private practices). The Department also incorporates the Tissue services for the Trust; this Department is responsible for managing and ensuring compliance of the licensable activities which falls under the HTA Human Application Sector, this includes procurement, testing, storage, traceability, disposal and distribution of human tissue and cells for therapeutic use.

Cellular Pathology Department operates within the Quality Management System for Pathology Services and is led by a Clinical Service Lead Dr Bruce Tanchel.   A technical Service Manager, Head Biomedical Scientist, Saeeda Kauser oversees the management of the Department. Cellular Pathology participates fully in UK NEQAS External Quality Assurance schemes where appropriate.  The Laboratory works to ISO 15189 requirements and is assessed by UKAS to evaluate compliance.  The vast majority of equipment, procedures and tests offered by the Department of Cellular Pathology are included in the UKAS scope of Accreditation seen here: https://www.ukas.com schedule 10141 .  Some non-accredited tests may also be used to support diagnostic tests and these are mainly reflected in stains, antibodies and associated platforms that are currently under assessment by UKAS for potential additions to the scope of laboratory testing. 

Some non-gynae cytology remains available at the QE Laboratory site but the majority of cytology samples across UHB are transferred to the Heartlands Hospital site for processing and staining.  The routine histopathology repertoire includes specialist renal, liver, muscle and nerve processing and reporting and a well established electron microscopy service.

The Department provides a comprehensive pathology service to the Trust, South Birmingham Community and Mental Health Trusts, Private Hospitals, General Practitioners and General Dental Practitioners.  The core laboratory sites are open Mon-Fri between 08:00 and 17:30 with QE Cell Path also open Sun 07:00-15:00 and Heartlands Cell Path Sat 09:00-12.45. A specialist/expert referral service is also provided to hospitals in the West Midlands, nationally and to international clients.

The Department operates within the Quality Management System of the Clinical Laboratory Services and is led by both a consultant medical Clinical Service Lead and a technical Service Manager. Cellular Pathology participates fully in UK NEQAS External Quality Assurance where appropriate.

Personnel 

Specimen requirements