Pathology User Guide

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 1 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

PATHOLOGY USER GUIDE

Version 2021.1

Document Number : MB 129 Approved By: David Whittington

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 2 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

CONTENTS

GENERAL INFORMATION...... 5 INTRODUCTION ...... 5 ADDRESS ...... 5 LOCATION ...... 5 GENERAL ENQUIRIES ...... 5 OPERATIONAL PATHOLOGY LABORATORY MANAGER ...... 6 SERVICE AVAILABILITY ...... 6 PHLEBOTOMY SERVICE ...... 6 TESTS AND SAMPLES ...... 7 PERSONS MAKING REQUESTS ...... 7 CONSENT ...... 8 REQUEST FORMS ...... 8 General ……………………………………………………………………………………………………..8 Completion of the Request Form ...... 8 SAMPLE LABELLING ...... 9 General ……………………………………………………………………………………………………9 Blood Transfusion ...... 10 SPECIMEN TRANSPORT TO THE LABORATORY ...... 10 Packaging and Sending Samples to the Laboratory ...... 10 Ward and Clinic Collection Times ...... 10 Pneumatic Air Tube System ...... 11 Urgent Requests during Routine Working Hours ...... 12 Unstable Analytes ...... 12 Out-of Hours Specimen Transport ...... 12 GP Transport ...... 12 RESULTS AVAILABILITY ...... 13 LABORATORY COMPUTER ...... 13 RESULTS INTERPRETATION ...... 13 REFERENCE RANGES ...... 14 MEASUREMENT UNCERTAINTY ...... 14 DOWNTIME ...... 14 COMPLAINTS ...... 14 Complaints by Requesters of Tests ...... 14 Complaints by Patients ...... 15 PATIENT CONFIDENTIALITY ...... 15 BLOOD SCIENCES ...... 16 BIOCHEMISTRY ...... 16 TELEPHONE NUMBERS ...... 16 ENQUIRIES and CLINICAL ADVICE ...... 16 URGENT REQUESTS ...... 16 REFERRED TESTS...... 16 ON-CALL SERVICE...... 17 RESULTS ...... 17 ALERT / CRITICAL ACTION LIMITS ...... 17 TOXICOLOGY ...... 18 THERAPEUTIC DRUGS ...... 19 CARDIAC MARKERS ...... 19 LIVER FUNCTION TESTS ...... 19

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 3 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

THYROID FUNCTION TESTS ...... 19 LIPIDS ……………………………………………………………………………………………………19 REJECTED REQUESTS ...... 19 BIOCHEMISTRY TIME LIMITS FOR REQUESTING ADDITIONAL TESTS ...... 20 ARTEFACTS ...... 22 FORMULAE ...... 23 BIOCHEMISTRY TEST GUIDE ...... 23 BIOCHEMISTRY DEPARTMENT REFERENCE LABORATORIES ...... 47 HAEMATOLOGY ...... 48 TELEPHONE NUMBERS ...... 48 URGENT REQUESTS ...... 48 ON-CALL SERVICE...... 48 RESULTS ...... 49 HAEMOGLOBINOPATHY SERVICE ...... 49 TOP TEN HAEMATOLOGICAL INVESTIGATIONS ...... 49 HAEMATOLOGY TIME LIMITS FOR REQUESTING ADD ON TESTS ...... 52 FACTORS THAT CAN AFFECT SAMPLE INTEGRITY...... 53 HAEMATOLOGY TEST GUIDE ...... 53 TEST REPERTOIRE ...... 54 REFERRAL TESTS ...... 61 BLOOD TRANSFUSION ...... 63 SPECIMEN REQUIREMENTS ...... 63 IMPROVING THE SAFETY OF BLOOD TRANSFUSION: ABO CONFIRMATORY TESTING ... 63 TEST REPERTOIRE ...... 64 TURNAROUND TIMES ...... 67 REFERRAL TESTS ...... 68 MICROBIOLOGY ...... 69 INTRODUCTION ...... 69 LABORATORY HOURS ...... 69 AVAILABILITY OF CLINICAL ADVICE ...... 69 ON-CALL SERVICE ...... 69 TELEPHONE NUMBERS ...... 70 USE OF THE LABORATORY ...... 70 Requesting ...... 70 Requesting Additional Tests ...... 71 Specimen Containers ...... 72 TURNAROUND TIMES ...... 73 BACTERIOLOGY ...... 73 GENERAL REPORTING GUIDELINES ...... 73 1. Urinary Tract Investigation ...... 74 2. Gastrointestinal Disease Investigation ...... 77 2.4 Specimen collection for Helicobacter Antigen testing ...... 79 2.5 Specimen collection for Norovirus Investigation ...... 80 3. Sterile Body Fluid Investigation ...... 80 4 Superficial/Non-Superficial Body Sites/Tissues/Abscess/Other Body fluids/Tips Investigation ...... 83 Abscess ...... 83 Ear ……………………………………………………………………………………………………83 Eye ……………………………………………………………………………………………………84 5 Throat swabs ...... 84 6 MRSA SCREENING INVESTIGATION ...... 84 7 Miscellaneous investigation ...... 85 8 Blood Culture Investigation ...... 86 9 Respiratory Sample Investigation ...... 89 10 Skin, Hair and Nails Investigation for Dermatophyte ...... 93

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 4 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

11 INVESTIGATION OF GENITAL INFECTIONS ...... 94 12 SEMEN ANALYSIS ...... 97 VIRAL ISOLATION ...... 99 SEROLOGY/IMMUNOLOGY ...... 100 TAKING THE SAMPLE ...... 129 THERAPEUTIC DRUG MONITORING ...... 139 HISTO/CYTOPATHOLOGY ...... 140 TELEPHONE NUMBERS ...... 140 GENERAL INFORMATION ...... 140 HISTOPATHOLOGY INVESTIGATIONS ...... 141 Sending the specimen ...... 141 Availability of formalin containers ...... 141 Request Forms ...... 141 When will the result be available? ...... 141 Urgent reports ...... 142 Frozen sections ...... 142 Factors known to affect the interpretation of histology specimens ...... 142 How do I get histology results? ...... 143 POST-MORTEM EXAMINATIONS ...... 143 CYTOLOGY INVESTIGATIONS ...... 143 DIAGNOSTIC (NON-GYNAE) CYTOLOGY ...... 144 MORTUARY SERVICES ...... 148 MEDICAL CERTIFICATES OF CAUSE OF DEATH (MCCD) ...... 148 CAUSE OF DEATH STATEMENT ...... 148 ISSUING A MEDICAL CERTIFICATE OF CAUSE OF DEATH (MCCD) ‘OUT OF HOURS’ ...... 149 REPORTING DEATHS TO H.M. CORONER ...... 150 CREMATION FORMS ...... 152 POST-MORTEMS ...... 153 POST-MORTEM REPORTS: ...... 153 REQUESTING HOSPITAL POST-MORTEMS ...... 153 MORTUARY APPENDIX I ...... 155 WHY ARE POST-MORTEM EXAMINATIONS (AUTOPSIES) PERFORMED? ...... 155 MORTUARY APPENDIX II ...... 156 ISSUING MEDICAL CERTIFICATES FOR CAUSE OF DEATH (MCCD) ‘OUT-OF HOURS’ ...... 156 ADULT BD BLOOD TUBE GUIDE ...... 157

PAEDIATRIC BLOOD SAMPLE COLLECTION GUIDE ...... 158 ADULT BD BLOOD SAMPLE COLLECTION GUIDE ...... 161 MINIMUM REPEAT INTERVALS FOR DIRECT ACCESS PATHOLOGY INVESTIGATIONS ...... 185

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 5 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

GENERAL INFORMATION

INTRODUCTION

The pathology department at Whittington Health is comprised of the following specialist laboratories: . Biochemistry / Haematology (Blood Sciences) . Blood Transfusion . Microbiology / Andrology / Immunology . Histology / Cytology / Mortuary We provide a wide range of analytical and advisory services, which are available for inpatients, outpatients and the community at large. Approximately 700,000 patient samples are handled per annum, 40% of which are from general practice. To ensure the highest standard of work we participate in extensive internal and external quality assurance schemes. The department (Lab number 8200) is UKAS accredited to ISO15189:2012. https://verify.ukas.com/b2a43801-e290-4569-8538-cf346257cc2c#gs.jh8xrt Our accreditation is limited to those activities described on our UKAS schedule of accreditation Whittington Health Schedule of Accreditation The information in this user guide is intended to allow Whittington Health staff and the General Practitioners to make optimum use of our services. All comments are welcome. The guide is available on the intranet, extranet or a hard copy can be obtained by contacting Tope Adebisi-Daniel on 020 7288 3130 or by e-mail at [email protected] stating the contact person and the destination to which the guide is to be sent.

ADDRESS Level 5, K Block (Outpatients Block) Magdala Avenue London, N19 5NF

LOCATION

Using the main hospital entrance in Magdala Avenue, take the escalators to Level 1 then bear right up the ramp into the diagnostic block. Take the lift to level 5: Pathology reception is to the right on leaving the lift. All visitors (including patients delivering samples or requiring blood tests) should report to reception which is located in the phlebotomy waiting area.

GENERAL ENQUIRIES

Specific contact details are included in the departmental sections which follow. The frontline telephone numbers for Pathology are: BLOOD SCIENCES: 020 7288 5775/5776 BLOOD TRANSFUSION: 020 7288 5766 HISTOCYTOPATHOLOGY: 020 7288 5076 MICROBIOLOGY: 020 7288 5088

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 6 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

DIRECTOR FOR CLINICAL SUPPORT 020 7288 3763 SERVICES: PATHOLOGY EMAIL: [email protected] OPERATIONAL PATHOLOGY LABORATORY MANAGER

Any queries that cannot be addressed by the general enquiries telephone lines or the Service Managers can be addressed to the Operational Laboratory Manager Nazia Hussain 0207 2885832 [email protected] SERVICE AVAILABILITY

Routine working hours for the laboratories are: Monday to Friday: 09:00 to 17:30 (Microbiology only provide emergency out of hours service after 17:00) Saturday: 09:00 to 13:00 (restricted service excluding Histopathology)

Biochemistry, Haematology and Microbiology provide an on-call service for urgent samples at all other times. General Practice patients may leave routine samples in the post box attached to the Pathology entrance door at any time that they have access to the floor. This is typically up until the early evening. The box is checked regularly until midnight and any samples will be stored and refrigerated at 2-8OC. They will be processed on the next working day.

PHLEBOTOMY SERVICE

A phlebotomy service on site is provided for General Practice patients between 09:00 and 16:30, Monday to Friday, excluding Bank Holidays. These patients can be seen without an appointment, but they must have a request form with 3 identifiers, signed by a Doctor. All mornings are very busy and there will be a delay before you can be seen. Afternoons are generally quiet with much shorter waiting times. Hospital outpatients should be bled in the clinic where they have been seen. Additional information . Fasting tests, i.e. Glucose tests – patients should not have anything to eat for 12 hours before coming, however they may drink water. These patients should be advised to attend for their blood test as early as possible for their own comfort and convenience. . Glucose tolerance tests (GTT) – these tests need to be booked via the Diabetic clinic. Please contact 0207 288 5511 . Fertility testing – progesterone samples need to be taken between day 21-24 of the cycle (28 day cycle) . LH/FSH – samples need to be taken between day 2-5 of the cycle. . 24 hour urine collection containers are supplied to GP surgeries. They can also be obtained from clinics or pathology specimen reception. Acidified containers can only be obtained from the laboratory

Adult Outreach Phlebotomy is provided at the following locations:

Dartmouth Park Surgery, 18 Dartmouth Park Hill, London NW5 1HL 0207 273 1337 Tuesday and Thursday only (9:30-13:00)

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 7 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Highbury Grange Medical Practice, 1-5 Highbury Grange, London N5 2QB 0207 226 2462 Monday and Thursday only (9-12:30)

Islington Centre Medical Practice 28 Laycock Street, London N1 15W Tele: 0207 359 0445 Monday - Friday (08:30-12:30), and (13:30-17:00)

The Mildmay Medical Practice, 2a Green Lanes, London N16 9NF 0207 923 1999 Wednesday & Thursday (8:30-13:00)

Northern Medical Centre, 580 Holloway Road, N7 6LB 0203 316 1800 Tuesday, Thursday & Friday only (8:30-12:30)

Queenswood Medical Practice, 151 Park Road, London N8 8JD Tele: 0203 074 2403/4 Mornings (8-13) only Monday to Friday

TESTS and SAMPLES

Available tests and their sample requirements are listed in the Blood Tube Guides at the end of this booklet. Most tests are available routinely but the laboratory may exercise discretion if they feel tests are being requested inappropriately. The service is under constant review and seeks to be responsive to the requirements of the users. Certain tests require specific sample containers: patients should be asked to collect such containers by reporting to Pathology reception as above. Guidance has been provided by NHS London for minimum repeat intervals for direct access pathology investigations. Please refer to table in the section: Minimum Repeat Intervals for Direct Access Pathology Investigations (see Contents) for details.

PERSONS MAKING REQUESTS

The responsibility for requesting a laboratory service or test lies with an authorised and trained practitioner (normally a clinician). It is the responsibility of the requester to ensure that samples are correctly labelled and request forms are completed to agreed standards. The requesting practitioner is responsible for the results and for any action taken as a result of the report. Only staff that have received specific training (including, where appropriate, the need for permission and/or counselling) may use the ordering system.

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 8 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

CONSENT The Pathology department follows the Trust ‘Policy on consent for examination or treatment’ (POL/CL/0239). This policy is based on Department of Health guidance and specifies how clinicians requesting examinations and investigations on patients should meet the requirements for patient consent. “Consent” is defined as a patient’s agreement for a health professional to provide care and the responsibilities of health professionals are clearly defined. It is the responsibility of the clinician to ensure the patient understands the reason for making the request for an examination or investigation and the range of tests that may be involved. Patients can give consent orally or in writing, or they may imply consent by complying with the proposed examination or treatment, for example, by rolling up their sleeve to have their blood sample taken. REQUEST FORMS General Inpatients Blood Sciences – Biochemistry & Diagnostic Haematology, Microbiology and some Histopathology inpatient requests are made via Sunquest ICE. Please refer to Sunquest ICE Pathology Tests Requesting for details. Note: If request is for ANC patient at booking a prompt to ensure Family Origin Questionnaire (FOQ) is completed will appear. The member of staff making the request must fill in all relevant details. Training and appropriate permissions are available from IM&T. Requests for logon codes are available on the intranet. In the event that Sunquest ICE is not available for an extended period of time Emergency Contingency Pathology Forms are available. Please contact the Laboratory for access to these. Please note that these forms will only be accepted during the period of Sunquest ICE downtime and inappropriate use will result in samples not being processed.

General Practitioners A common request form for Biochemistry, Haematology and Serology is in use. Separate forms are available for Microbiology and Histopathology / Cytology. The National form HMR 101/5 is supplied for cervical smears. Electronic requesting is available. Completion of the Request Form

All general practitioners are assigned a four digit computer code: quoting this code on request forms helps to ensure that we return reports to the correct address or secretary; doctors working at more than one practice will have a code assigned for each address. Sample and request form information must match. Professional guidance states that the following essential data is required on the request form:  NHS, CHI or Health and Care number  Patient’s full name or unique identifier  Date of birth and /or hospital number  Gender  Patient’s location and destination for report  Patient’s consultant, GP or name of requesting practitioner and contact details  Identity of person collecting the sample  Nature of the sample (e.g. blood, swab, fluid, sputum, etc.)

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 9 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

 Anatomic site of origin (where applicable)  Investigations required – use tick boxes, any additional tests should be clearly specified using only standard abbreviations where appropriate.  Clinical information including relevant medication - assist in the interpretation of results and scheduling other appropriate tests. Clinical information forms a key part of the quality process in that clinically inconsistent results will be double checked. See Duty of Care to Colleagues – below.  Date and time sample collected The addition of patient address and contact details on GP request forms is also required in order to provide urgent care during the out of hours period. Duty of Care to Colleagues • If the patient you are caring for has an infection, they and their body fluids/specimens may represent a health hazard to other staff members e.g. Pathology. • Remember, to ensure safe handling of samples and isolates from these patients, full clinical information must accompany all requests to diagnostic departments. • The Health and Safety Executive are aware of life threatening infections that have occurred in laboratory staff where, due to inadequate clinical information, unexpected dangerous pathogens have been grown from samples. • These incidents are preventable when requestors perform their duties appropriately and give the correct clinical information on every request.

SAMPLE LABELLING General

Sample and request form information must match. Professional guidance states that the following essential data is required on the sample:  NHS, CHI or Health and Care number  Patient’s full name or unique identifier  Date of birth and or hospital number

Please note:  Samples or request forms received without the minimum essential identification criteria may be rejected without analysis or referred back to the requesting clinician.  Un-labelled samples and those where labelling is illegible/incomplete will not be analysed. No unlabelled specimens will be accepted in Blood Transfusion, Haematology or Biochemistry. They may not be labelled retrospectively and must be repeated. Some departments may make exceptions if the sample is unrepeatable, e.g. CSF, provided that the sample is received enclosed with the request form. The report will be issued with a comment to the effect that the sample was unlabelled.  Further Histopathology/Cytopathology information is found on Page 128.There are additional and mandatory requirements for Blood Transfusion as follows:

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 10 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Blood Transfusion

Blood transfusion samples must be labelled by hand. The identity details must match those on the patient wristband (if in-patient). Full name, date of birth, hospital number and signature of the person who took the blood must be on sample plus date and time that the sample was taken. Samples should only be collected and labelled from one patient at a time. The sample must be labelled immediately after collection, checking these details against those on the wristband. Where possible ask the patient to tell you their name and date of birth. The laboratory will refuse to process any sample with incomplete, illegible or inaccurate details. In this instance a repeat sample will be required.

SPECIMEN TRANSPORT TO THE LABORATORY Packaging and Sending Samples to the Laboratory

Samples should be sent in pathology specimen bags which are available on the wards and in clinics. Specimen bags have two compartments; the sample should be placed in the sealable compartment. Samples and request forms must be packaged correctly to ensure that the staff handling them are safe and that the request is sent to the correct laboratory. The Pink bags are for Haematology & Biochemistry samples, and the Blue ones for Microbiology and Serology. Make sure that the correct bags are used for the samples, as the colour of the bag will be used to sort the specimens in pathology reception. When you have taken the sample and completed the request form: 1. Place the sample in the plastic bag and seal it. 2. Fold the form in two (if you fold it in four it may fall out of the bag) with the information on the outside and put it in the back section, between the plastic and the paper. Ensure that the top half of the request page is visible through the plastic (not the bottom of the page) because when we are looking for urgent samples or sorting samples to be sent to the correct laboratory we need to be able to read the patient’s details and the tests requested. It does not need to be sealed in, and must not be put in the same section as the specimen. Samples are collected from wards and clinics and delivered to pathology reception where they are sorted and distributed to the various laboratories. Ward and Clinic Collection Times

The Pathology Porters leave the Department to do rounds at the following times: Wards, ANC & Paediatrics: 09.15am 11.00am 14.00pm 15.30pm Outpatients: 09.30am 11.00am 13.00pm 16.00pm Please make sure that samples are placed in the box by these times to ensure they reach the Laboratory as quickly as possible. Samples generated or ready for despatch after the last scheduled collection must be stored under appropriate conditions within the clinical area until the next day or, where the test is urgent or the sample type cannot be left overnight, sent to pathology by requesting a porter, or by using the Air Tube system described below.

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 11 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Pneumatic Air Tube System Description The air-tube system uses plastic carriers into which items may be placed to move them to other locations in the Hospital. Samples must be sealed inside specimen bags before loading into the carrier. Do not put blood gas syringes, or other large containers into the airtube system. It is intended solely for standard blood tubes and universal containers.

Each station has a 3-digit location code:

System One 010 : Pathology 020 : Emergency Department (A/E) 030 : Clinic 3A 040 : Clinic 3B (Haematology/Diabetic Clinics) 050 : Paediatric (Casualty) 052 : Main Pharmacy 060 : Clinic 4A 070 : Clinic 1A and 1B 090 : Theatres

System Two 200 : Mary Seacole South (Medical Assessment) 210 : ITU & HDU (Critical Care) 220 : Mary Seacole North (Medical Assessment) 250 : Mercers (Thalassaemia Clinic/Oncology) 260 : Nightingale (Acute Ward)

On each station are an LCD display and 3 coloured lamps. Red Continuously on : System in use elsewhere Red Flashing : Error Yellow : Carrier incoming Green : Carrier outgoing The LCD display will also indicate the location of “Arrival from” or “Dispatch to” which the carrier is travelling, and some status messages.

To Send NB: DO NOT USE THE AIRTUBE FOR HEAVY ITEMS! BIOLOGICAL SPECIMENS MUST ALWAYS BE IN A SEALED BAG  Place Item in carrier by twisting the top open. Then close lid.

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 12 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

 If the yellow “Carrier incoming light is on, it is advisable to wait for its arrival. When the carrier arrives the mechanism behind the door will move driven by a powerful electric motor. NEVER OPEN THE DOOR DURING A CARRIER ARRIVAL.  Firmly place carrier into the slot between uprights. Before closing the door, use the keypad to enter the 3-digit destination code. Casualty has a predefined location. 010 so all samples are sent to Pathology.  Close door. The display should indicate “SELECTION OK”. The carrier will then be sent to the destination. A high-pitched alarm indicates there may be a problem. To Receive  Ensure door is closed. Incoming carriers will drop into the basket. When the carrier arrives the mechanism behind the door will move driven by a powerful electric motor. NEVER OPEN THE DOOR DURING A CARRIER ARRIVAL.  Return the empty carrier to the sending station indicated on the LCD display and written on the carrier.  Useful Hint. To return the carrier to the station indicated on the LCD just press * and the same number will appear in the Dispatch to section.  Report any faults to Blood Sciences. EXT 5775. Urgent Requests during Routine Working Hours

Please contact the laboratory to discuss the availability of urgent tests. Samples should be dispatched by airtube or porter as appropriate. Do not leave for routine collection. Advise porters to take samples directly to the department concerned. Unstable Analytes

A number of samples require direct transport to the appropriate laboratory immediately after collection (see test guides elsewhere in this handbook). In these circumstances call a porter before taking the sample – or bring it directly to the laboratory yourself. Out-of Hours Specimen Transport

For areas not on the air tube system, or samples that cannot be put in the air tube, please phone portering, for them to collect and deliver to the Laboratory. GP Transport

The Trust contracts a courier company to distribute consumables and collect samples from GP practices. For enquiries or issues regarding this service please contact the Operational Laboratory Manager on 0207 288 5832.

INTEGRITY OF SAMPLE AND SAFETY TO THE PUBLIC Problems with specimens occasionally occur that could have been avoided by some attention to detail and adherence to correct procedures. Common problems include:  Delayed samples stored under inappropriate conditions.  Rejected samples due to incorrect or insufficient labelling.  Rejected samples due to leakage from container or breakage.  Rejected samples due to contamination of outside of container or request form.  Specimen received in inappropriate/hazardous container (e.g. syringe with needle)

To avoid these problems please ensure the following:

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 13 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

 Samples that are not despatched immediately to the laboratory should be stored as specified (for the specimen type) in this document.  All specimen containers must be labelled with at least three full unique identifiers and accompanied by a fully completed request form/printout.  The container should be checked for cracks or other damage before use. Once filled the container should be closed so that no leakage will occur. Check that the lid is pressed home tightly or, in the case of a screw cap, hand tightened securely without cross threading.  If instructing the patient to take a specimen (such as a faeces sample) please additionally emphasise the need to keep the outside of the container clean and free from contamination.  The specimen container should be placed in a sealed plastic bag with a separate compartment for the request form. The compartment containing the specimen should also contain some absorbent material to mitigate in the event of a leaking sample.  Do not send samples that contain sharp or pointed objects unless very securely contained - glass slides must be in a rigid, sealed slide transport box, needles are a serious hazard and unacceptable.

RESULTS AVAILABILITY

Most common automated tests will be run within one working day, though less frequent tests may be run in batches. The vast majority of reports for in-patient results are available on the computer system the same day, Some tests are referred to specialist laboratories and in this instance it may be some time before results are available. Results are subject to validation by senior staff, at which stage interpretative comments may be added and additional tests scheduled. Once all results are available a printed report is generated. General practice reports are dispatched daily either by hospital transport or first class post. We feel that most reports are issued within an appropriate timescale. Where results are unexpected, require explanation or may require urgent intervention we will endeavour to contact the requesting doctor. Results on hospital samples marked “urgent” will be released onto the computer as soon as they become available. General practice samples marked “urgent” or “please phone” will have their results telephoned: however we will not generally schedule such work ahead of other samples unless we are contacted in advance. FAXing of results is not available. Electronic transmission of biochemistry, haematology and microbiology results is available.

LABORATORY COMPUTER

The Trust uses the Sunquest ICE requesting and reporting system. Passwords and training are available via the IM&T helpdesk on 020 7288 5351. All general practitioners are assigned a four digit computer code. Quoting this code on request forms helps to ensure that we return reports to the correct physical and LabLinks address. Doctors working at more than one practice will have a code assigned for each address. Codes for new doctors are issued by Lynne Ellis (020 7288 5023) [email protected]

RESULTS INTERPRETATION

The laboratory may perform additional tests and add interpretative comments to reports. However we can only work with the information we have available and reports should be interpreted in this light. As mentioned above we will often contact the requesting doctor in difficult cases. Since the laboratory is not usually aware of the overall clinical picture we are reluctant to discuss results directly with patients and will generally refer them back to the doctor making the request.

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 14 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

No quality system is fool-proof and random errors will always occur. We appreciate being informed of inconsistent findings since this allows results to be checked and may reveal procedural problems affecting other patient results.

REFERENCE RANGES

Reference ranges for numeric tests included in this user guide are for guidance only: clinical decisions should always be based on the range printed on the report or transmitted electronically with the result. New technologies often cause changes in reference limits. Any changes in reference ranges would trigger an immediate update of this manual to reflect the revised values. Reference ranges are determined by carrying out measurements on a carefully selected and precisely defined reference (normal) population. The reference range is calculated as the mean +/- 2SD of all measurements but by definition only includes 95% of the reference population, i.e. 1 in 20 of the reference (normal) population will have a result outside the reference range. When large batteries of tests are requested the problem is exacerbated, for example if 20 analytes are measured on a reference (normal) individual there will be a greater than 50% chance that one analyte will be outside the reference range. This emphasizes the point that not all results outside of reference ranges will be associated with disease. However, the further a result is away from the reference range then the more likely it is that it represents a pathological change. A number of the normal ranges are based on a largely Caucasian population and may differ for other racial groups. Examples are higher ranges for creatine kinase in Afro-caribbeans and amylase in Asians.

MEASUREMENT UNCERTAINTY No measurement or test is perfect and the imperfections may give rise to error of measurement in the result. Therefore a measurement or test only gives an approximation of the true value measured. The possible difference to the true value, or the measurement uncertainty (MU), is estimated and reported as part of any good laboratory practice.

It should be noted that the departments are implementing an ongoing programme to calculate uncertainty of measurement for test results, but recognises that that this is a developing field and implementation is proceeding at an appropriate pace. The laboratories will take into account data obtained from the internal quality control schemes and other relevant sources. It must be appreciated that because of the difficulties in estimating uncertainty in with non-numeric testing, routine testing is backed up by a comprehensive programme of External Quality Assessment (EQA) and Internal Quality Control (IQC). Please contact the relevant Service Manager for further information.

DOWNTIME

All laboratory equipment is prone to occasional breakdown and may also be temporarily unavailable for scheduled maintenance. The laboratory makes every effort to minimise the impact on service users but there may be delays in issuing results in such circumstances. Following serious downtime the laboratory attempts to prioritise the backlog of work appropriately.

COMPLAINTS Complaints by Requesters of Tests

The Pathology Department makes every effort to maintain a high standard of service at all times. However, mistakes do occur and we are happy to receive any comments and to try to resolve any complaints, normally within 15 days. If you have a complaint, please speak in the first instance to the Service Manager of the department concerned, whose contact numbers can be found in the individual sections. If this call fails to meet your requirements please state that you wish to proceed to a formal complaint. The manager will complete a quality improvement form and the complaint and any action taken as a result will stay on permanent record.

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 15 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Complaints by Patients

These should all be referred to the Patient Relations Department Complaints Service at the following points of contact: Telephone: 020 7288 5551 E-mail: [email protected]

PATIENT CONFIDENTIALITY Behaviour and practice in respect of confidential information is governed by the codes of conduct of most clinical professions, by Department of Health publications, such as Confidentiality - NHS Code of Practice and by laws such as the Data Protection Act 1998, Human Rights Act 1998, as well as the Caldicott Guidelines, common law and such obligations undertaken by the Trust in contracts with third parties.

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 16 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

BLOOD SCIENCES

BIOCHEMISTRY

The Biochemistry Department offers a wide range of investigations including general chemical pathology, endocrinology and therapeutic drug monitoring. More specialised investigations may be sent to reference laboratories.

TELEPHONE NUMBERS Consultant Clinical Scientist . Dr Michelle Young 02072885046

Principal Clinical Scientist: Vacant 020 7288 5041

Service Manager Andrea Barrows: 020 7288 5043 [email protected] Results and General Enquiries: 020 7288 5775/6 Clinical enquiries: 020 7288 5046 On Call Biomedical Scientist: 020 7272 3070: Bleep 2626

ENQUIRIES and CLINICAL ADVICE

General enquiries should be made on our office number 7288 5775/6. Many questions can be dealt with by office staff. A clinical scientist is available at all times for more complex and clinical enquiries. They will be happy to advise on result interpretation and the selection of investigations.

Please contact them via the Ext.5046 or by email to [email protected]

We recommend the following website for patients who want further details on laboratory tests: http://www.labtestsonline.org.uk/ URGENT REQUESTS

Most tests can be prioritised in exceptional circumstances: please contact the laboratory in advance of sending the sample or bring the sample to the lab by hand and inform the lab staff that the request is urgent.

REFERRED TESTS

Many low demand assays are referred to reference laboratories for analysis. Reports on these tests are slower since time must be allowed for transport of the sample and most laboratories will batch

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 17 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021 analyses. A list of reference laboratories used by the laboratory is included in this guide. The analysing laboratory is always displayed with results.

ON-CALL SERVICE

An on-call service operates at all times outside routine working hours. This is covered by a single member of staff and requests should be restricted to those tests affecting immediate patient management. After midnight urgent requests must be arranged in advance with the Duty Biomedical Scientist by bleeping 2626. Samples will otherwise be analysed with the next batch – usually within a couple of hours. It is not generally possible for telephone extensions within the department to be manned out of hours. The following tests can normally be arranged out of hours: U&E, Creat, Glucose, Blood Gases, Amylase, Osmolality, LFTs, Bone Profile, CRP, Ammonia, Lactate, Magnesium, Conjugated Bilirubin (neonates only), CSF Glucose and Protein, Troponin T. Urine Sodium/Potassium/Osmolality. Salicylate, Paracetamol, Alcohol, Carboxyhaemoglobin, Lithium, Iron. Other toxicology samples may be saved. Lithium and Iron are available only in cases of suspected overdose. CSF Xanthochromia requests are sent to a referral laboratory during routine hours only, Mon-Fri. Other tests may be available on discussion with the on-call Biomedical Scientist or senior member of staff on duty.

RESULTS

Results are available to enquiry on Sunquest ICE within about 5 minutes of authorisation by the laboratory. Reports are printed and distributed several times daily. Within the hospital results will not generally be issued by telephone: enquirers will be expected to access results via the Sunquest ICE system. This is more secure and reduces the risk of transcription errors. Enquirers from general practice will be asked to confirm their identity by quoting the requesting doctor’s computer pass code. Results for general practice are transmitted electronically periodically throughout the day. Printed reports are dispatched daily but an increasing number of practices are now paperless. This can be arranged by contacting the laboratory. FAX is considered an insecure method of communicating results. Individual results may be electronically transmitted (or re-transmitted) on request

Alert / Critical Action Limits Generally all results outside these limits or situations should be brought to the attention of the requesting clinician / nominated staff member as soon as possible and where clinically indicated, i.e. ALL significantly abnormal results seen for the first time OR where there has been a significant change in the results.

Clinical staff must be notified of all cases of unexplained discrepant results.

For urgent requests the requesting clinician should be notified of any clotted, unlabelled or under filled samples.

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 18 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Examination Result Phone Below Phone Above Sodium 120 150 Potassium 2.8 6.2 TC02 10 Urea 30.0 Creatinine 354 Corrected Calcium 1.80 3.2 Phosphate 0.40 Salicylate 300 Paracetamol 15 Glucose 2.5 25 CSF Glucose 2.5 CSF Protein 1.0 Amylase 500 Troponin-T 100 Bilirubin (<1month) 300 Cortisol 100 Magnesium 0.4 2.5 Lithium 1.5 Digoxin 2.5 CK 5000

TOXICOLOGY Full toxicology screening in patients suspected to have overdosed is a complex and expensive undertaking and is not routinely available for clinical management of patient care. A standard drugs of abuse screen can be referred to a specialist laboratory for analysis. This screen will identify the following drugs: Cocaine, Cannabis, Methadone, Amphetamines, Opioids, Buprenorphine, Benzodiazepines.

If results are required urgently or other drug tests are required please contact the laboratory to discuss. A limited panel of drugs is available for rapid screening in the laboratory, however this is only available with the approval of an ITU registrar or consultant.

Samples which are not dispatched for analysis are stored for 3 months in case they are required for retrospective analysis at a later date.

Urine samples for drugs of abuse screening may be submitted routinely. Note that this is a clinical service and is not suitable for testing for legal purposes (e.g. employment, child custody).

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 19 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

THERAPEUTIC DRUGS

Therapeutic drug requests must include the date and time of dose and sample. Routine assays available are: Sampling Carbamazepine Immediately before an oral dose Digoxin > 6 hours post dose Lithium > 12 hours post dose Phenobarbitone Immediately before an oral dose Phenytoin Immediately before an oral dose Theophylline Immediately before an oral dose If IV then >12 hours after initiation Valproate Immediately before an oral dose Other tests may be available by arrangement with the laboratory. CARDIAC MARKERS The laboratory’s current cardiac marker is Troponin T. Samples should be taken at least 6 hours post event. Please see NICE guidelines DG40. Values >100 ng/L are highly suggestive of AMI while values between 3 and 100 ng/L are consistent with ACS. Negative or equivocal results should be repeated at 12 hours. There is no benefit in repeating positive results.

LIVER FUNCTION TESTS The laboratory routinely offers total protein, albumin, total bilirubin, alkaline phosphatase and ALT as a routine liver profile. Additional tests may be scheduled if abnormal results are found.

THYROID FUNCTION TESTS Thyroid stimulating hormone (TSH) is the laboratory’s front-line test of thyroid function. Scheduling of further tests (free T4, free T3, TPO antibodies) depends on the TSH result, the clinical details supplied on the request form and, occasionally, on previous thyroid function results.

LIPIDS A front line fasting sample is no longer required. Changes will be made in the near future to requesting profiles available to reflect this. Where applicable LDL Cholesterol is estimated using the Friedewald formula (see FORMULAE section).

REJECTED REQUESTS The laboratory computer (Winpath) has been programmed with time limits (see below) within which certain analytes cannot be re-requested. An appropriate comment is added to inform users of the test being rejected, the re-testing period and a contact number to talk with a clinical scientist. If there are any exceptional circumstances the test can be re-instated if the laboratory is contacted within 5 days so that the sample is not discarded. The re-requesting time limits are:- C3 C4 – 30 days IgA- 7 days Fructosamine – 13 days PSA – 14 days TSH, FT4 and FT3 – 28 days Tumour Markers (CEA, CA125, CA15-3, CA19-9) – 28 days Protein Electrophoresis and Bence-Jones Protein – 28 days HbA1c – 42 days TPO-Antibodies – 180 days NT-Pro-BNP and Trab – 365 days

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 20 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

There are a number of exceptions to the duplication rules programmed into Winpath, these are:

TSH/ft4/ft3 – duplication rules do not apply to children under 1 year nor requests coming from the Endocrine consultants HbA1c – duplication rule does not apply in pregnancy (requests from ANC) Tumour Markers – duplication rules do not apply to samples coming from the Oncology team. Drs Davis or Leonard

BIOCHEMISTRY TIME LIMITS FOR REQUESTING ADDITIONAL TESTS

Add-on tests can be accepted within the time limits shown in the table below. These time limits assume that the sample was not initially haemolysed or lipaemic and that the sample was originally taken into the correct container as listed elsewhere in this handbook. The information is based on manufacturer’s information (when available) and on the document: “WHO Use of Anticoagulants in Diagnostic Laboratory Investigations and Stability of Blood, Plasma and Serum Samples (2002)” http://whqlibdoc.who.int/hq/2002/WHO_DIL_LAB_99.1_Rev.2.pdf To add a test or for further advice please contact the laboratory on 020 288 5775. Note that the laboratory only retains samples for about 7 days due to limited refrigerated storage.

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 21 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Add-on test Alk Phos 7 days AFP 7 days ALT 3 days Amylase 7 days Androgens 3 days AST 7 days Beta-HCG 3 days Bicarbonate 6 hours Bilirubin 7 days Bone Profile 5 days CRP 7 days CA12-5 3 days CA19-9 3 days Calcium 7 days Carbamazepine 5 days CEA 7 days Chloride 7 days Cholesterol 7 days CK 7 days Cortisol 7 days Creatinine 7 days Digoxin 7 days Free T3/T4 7 days FSH 7 days Gamma-GT 7 days HbA1c 3 days HDL-Chol 7 days Igs 7 days Iron 7 days LDH n/a LFT’s 7 days LH 7 days Lithium 7 days Magnesium 3 days Oestradiol 7 days Osmolality 7 days Paracetamol 7 days Phenytoin 5 days Phosphate 3 days

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 22 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Add-on test Potassium 3 days Progesterone 3 days Prolactin 7 days Protein 7 days Protein EPS 7 days PSA 5 days SACE 7 days Salicylate 7 days SHBG 3 days Sodium 7 days Testosterone 7 days Theophylline 5 days TIBC 7 days Total CO2 5 days Triglycerides 7 days Troponin-T 24hrs TSH 7 days Urate 5 days Urea 7 days Valproate 7 days

S = Serum F - Fluoride

ARTEFACTS

There can be many artefactual influences on Biochemistry results: a few of the commoner ones are as follows: Common Analytes Affected Delayed separation Many analytes are affected if there is a  Potassium delay in transporting samples to the  Phosphate laboratory. In general all samples should  Magnesium reach the laboratory within 6 hours of venesection. There are specific examples where samples must be processed immediately (e.g. certain hormone assays). Details are available in the test guide. Refrigeration is not recommended: it actually increases the rate at which potassium leaks from erythrocytes. Haemolysis Haemolysed samples may be unsuitable for  Potassium analysis either due to the high level of an  Phosphate analyte in the erythrocyte relative to plasma  Magnesium or for reasons of analytical interference.

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 23 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Common Analytes Affected

High platelets/white Potassium may be released from  Potassium cells platelets/white cells during clotting of serum samples. Samples with high platelets/white cells may give artefactually elevated potassium results Lipaemia Lipaemia causes analytical interference in a  Sodium number of methods. Prolonged venous Fist clenching can also influence potassium  Potassium stasis results.  Proteins  Calcium EDTA contamination Seen when blood from an FBC tube is  Potassium added to the biochemistry sample.  Calcium Samples are analytically assessed for haemolysis, lipaemia and icterus. Where such interferences are detected results will be automatically suppressed. FORMULAE Calcium Adjustment for Albumin Binding Adjusted Calcium = Measured Calcium + ((40-Albumin)  0.02) This should be considered an approximation and the patient’s acid-base status always taken into account when interpreting calcium levels. The formula is not valid if serum albumin is <16 g/L. This is the formula used in reporting adjusted calcium. Calculated Osmolality Calculated Osmolality = (2  Sodium) + Urea + Glucose This should correlate with the measured osmolality to within 10 mosmol/kg unless there are significant quantities of unmeasured osmotically active species present (e.g. alcohol) or the sample is grossly lipaemic or hyperproteinaemic. LDL Cholesterol LDL Cholesterol = Total Cholesterol - HDL Cholesterol - (Triglycerides  2.2) (Friedewald formula) Triglycerides must be less than 4.5 mmol/l and the formula applies to fasting samples only. Ideal values are < 4.1 mmol/l. Anion Gap Anion Gap = (Sodium + Potassium) - (TCO2 + Chloride) Ref range: 12 - 20 mmol/l

BIOCHEMISTRY TEST GUIDE

For further details please contact the laboratory on extension 5775. Key Tests Not all of the tests listed are available routinely. Tests highlighted in red may be vetted. The majority of immunology tests are dealt with by the serology department and require a separate (red top) sample.

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 24 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Container All samples should be sent to the laboratory as promptly as possible: most assays will show some deterioration with time. In some instances rapid processing of the sample is essential: in the table below such assays are marked in blue. These samples must be brought directly to the laboratory and not left for routine collection. The laboratory uses the BD Vacutainer system for blood samples – tube cap colours prefix the container entries below. Paediatric equivalents are: No anti-coagulant White Top 2ml Heparinised Orange Top 2ml Fluoride-Oxalate Yellow Top 1ml EDTA Red Top 2ml Lesser volumes are frequently adequate for paediatric testing: please contact the laboratory as required. 24 hour containers – with or without preservative – are available from blood sciences specimen reception. Patient information on how to collect a 24hr Urine collection is available at Whittington NHS Trust Intranet: Pathology patient leaflets For some tests there are dietary or drug restrictions if in doubt, check with your Dr, nurse or midwife before beginning the specimen collection. Please do not take any of the following for 3 - 4 days before starting the collection or during the collection period for 5HIAA - Bananas / Avocados / Red Plums / Egg Plant / Tomatoes / Pineapple Walnuts / Cough Medicines

Please note all patient medication must be recorded on Catecholamines request forms For further information on the preparation of the patient for all other tests please refer to Lab Tests Online-UK Volume All volumes are in mL except where stated. The preferred volume indicates the ideal sampling, which is directly from the primary tube, for single or multiple tests. Note that several tests are often analysed from the same sample and the preferred volume will include multiple tests, as indicated on the request form or via order communications.

Where sample volumes are difficult to achieve the laboratory will provide guidance on minimum volume required.

Condition This column mainly lists age brackets for reference ranges. Age bands are successive and include the end age in the band: this is best illustrated by an example; assume a test shows these bands: Up to 1 year reference range is from birth to 1 year and 364 days Up to 4 years reference range is from 2 years to 4 years and 364 days Up to 128 years reference range is from 5 years onwards (128 is an arbitrary figure showing no practical upper age limit).

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 25 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Reference Range Reference ranges for numeric tests are for guidance only: clinical decisions should always be based on the range printed on the report or transmitted electronically with the result. New technologies often cause changes in reference limits.

Units An entry of ‘n/a’ generally means a qualitative test which has no numeric reference range.

TAT (Turnaround Time) This is the time in which the laboratory would expect to have a result available – from receipt of sample to availability of results for electronic enquiry (printed reports may take longer since they are batched). Turnaround can vary widely – particularly for tests sent to reference laboratories. In the event of an unreasonable delay please speak to a senior member of laboratory staff. *TAT only applies to routine working days

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 26 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Volume Test Container Specimen Type Condition Reference Range Units TAT* (mL) May be vetted Bring straight to lab On Site Tests Referred to other Labs

BLOOD

6TGN Lavender EDTA Whole sample 4 21 days 17-OH Progesterone Gold - No anticoagulant Serum 5 see report nmol/L 21 days 6 months to 18 years 29 to 112 ACE Gold - No anticoagulant Serum 5 iu/L 7 days >18 years 20 to 70 ACTH Lavender - EDTA Plasma 4 All 1 to 50 ng/L 21 days Acyl Carnitine Blood Spot (Guthrie Card) Blood n/a see report n/a 21 days AFP Gold - No anticoagulant Serum 5 All 0 to 6 ku/L 8 hours

up to 4 days 28 to 44 up to 14 years 38 to 54 Albumin Gold - No anticoagulant Serum 5 g/L 4 hours up to 18 years 32 to 45 up to 128 years 35 to 50

Alcohol Grey - Fluoride Oxalate Plasma 2 All 0 to 10 mg/dL 4 hours Aldosterone Lavender - EDTA Plasma 4 see report pmol/L 21 days Alk Phos Isoenzymes Gold - No anticoagulant Serum 5 see individual fractions n/a 21 days

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 27 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Volume Test Container Specimen Type Condition Reference Range Units TAT* (mL)

up to 14 days 83 to 248 up to 1 year 122 to 469 up to 10 years 142 to 335 up to 13 years 129 to 417 up to 15 years Males 116 to 468 Alkaline Phosphatase Gold - No anticoagulant Serum 5 iu/L 4 hours up to 15 years Female 57 to 254 up to 17 years Male 82 to 331 up to 17 years Female 50 to 117 up to 128 years Male 40 to 129 up to 128 years Female 35 to 104

up to 6 months 0.9 to 2.2 up to 1 year 0.8 to 1.8 up to 5 years 1.1 to 2.0 Alpha-1-Antitrypsin Gold - No anticoagulant Serum 5 up to 10 years 1.1 to 2.2 g/L 21 days up to 15 years 1.4 to 2.3 up to 17 years 1.2 to 2.0 up to 128 years 1.1 to 2.1

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 28 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Volume Test Container Specimen Type Condition Reference Range Units TAT* (mL)

up to 1 year 0 to 41 up to 3 years 0 to 28 up to 6 years 0 to 29 ALT Gold - No anticoagulant Serum 5 iu/L 4 hours up to 12 years 0 to 36 up to 17 years 0 to 37 up to 128 years Female 0 to 33 up to 128 years Male 0 to 41

Aluminium Royal Blue Serum 5 see report ug/mL 21 days Amiodarone Gold - No anticoagulant Serum 5 see report n/a 21 days up to 1 month 0 to 100 up to 16 years 0 to 40 Ammonia Lavender - EDTA Plasma 5 umol/L 4 hours up to 128 years Female 11 to 51 up to 128 years Male 16 to 60 Amylase Gold - No anticoagulant Serum 5 All 28 to 100 u/L 4 hours

up to 10 years 0 to 3.6 Androstenedione Gold - No anticoagulant Serum 5 up to 128 years Female 1.0 to 12.2 nmol/L 14 days up to 128 years Male 2.4 to 12.6

Anion Gap Gold - No anticoagulant Serum 5 All 12 to 20 mmol/L 4 hours

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 29 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Volume Test Container Specimen Type Condition Reference Range Units TAT* (mL)

up to 1 year 0 to 58 up to 5 years 0 to 60 up to 6 years 0 to 49 up to 12 years 0 to 42 AST Gold - No anticoagulant Serum 5 iu/L 4 hours up to 17 years Female 0 to 38 up to 17 years Male 0 to 42 up to 128 years Female 0 to 31 up to 128 years Male 0 to 37

Beta 2 Microglobulin Gold - No anticoagulant Serum 5 All 0 to 2.3 mg/L 21 days

Male 0 to 2 Beta-HCG Gold - No anticoagulant Serum 5 up to 50 years Female 0 to 2 iu/L 8 hours up to 128 years Female 0 to 7 up to 16 years 0 – 19 Biliary ALP Gold - No anticoagulant Serum 5 u/L 21 days up to 128 years 0 – 8 Bile Acids Gold - No anticoagulant Serum 5 All 0 to 10 umol/L 3 days up to 1 day 0 to 103 up to 2 days 0 to 137 Bilirubin Gold - No anticoagulant Serum 5 up to 5 days 0 to 257 umol/L 4 hours up to 1 month 0 to 21 up to 128 years 0 to 21 All pH 7.35-7.45 All pCO2 4.5 – 6.2 kPa Blood Gases Blood Gas Syringe Arterial Blood 2 30 minutes NICU pO2 8 to 12 kPa All others pO2 11.1 to 14.4 kPa

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 30 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Volume Test Container Specimen Type Condition Reference Range Units TAT* (mL) Green - Lithium Heparin Blood Porphyrin Blood 5 n/a n/a 21 days (protect from light) up to 16 years 0 – 370 Bone ALP Gold - No anticoagulant Serum 5 up to 128 years –Female 0 – 44 u/L 21 days up to 128 years –Male 0 – 73 C3 Gold - No anticoagulant Serum 5 All 90 - 180 mg/dl 1 day C4 Gold - No anticoagulant Serum 5 All 10 - 40 mg/dl 1 day CA12-5 Gold - No anticoagulant Serum 5 All 0 to 35 u/mL 8 hours CA15-3 Gold - No anticoagulant Serum 5 All 0 to 25 u/mL 14 days CA19-9 Gold - No anticoagulant Serum 5 All 0 to 34 u/mL 7 Days Cadmium Lavender - EDTA Plasma 4 see report nmol/L 14 days Caeruloplasmin Trace element Serum 5 All 0.2 to 0.5 g/L 21 days Gold - No anticoagulant up to 128 years Female 0 to 5.5 Calcitonin Take on ICE spin & freeze Serum 4 ug/L 28 days up to 128 years Male 0 to 11.5 <30 mins up to 1 year 2.10 to 2.70 Calcium (adjusted) Gold - No anticoagulant Serum up to 4 years 2.10 to 2.60 mmol/L 4 hours up to 128 years 2.15 to 2.55 Carbamazepine Gold - No anticoagulant Serum 5 All 4 to 12 mg/L 8 hours Gold - No anticoagulant Carotenes Serum 5 All 1 to 4 umol/L 4 days (protect from light) CEA Gold - No anticoagulant Serum 5 All 0 to 4 ug/L 3 days Chloride Gold - No anticoagulant Serum 5 All 98 to 106 mmol/L 4 hours Cholesterol Gold - No anticoagulant Serum 5 see report mmol/L 8 hours Cholinesterase Gold - No anticoagulant Serum 5 see report n/a 21 days Royal Blue K2 EDTA Trace Chromium Serum 5 see report ug/L 21 days Metals (available from lab) All ages Female 26 – 192 CK Gold - No anticoagulant Serum 5 iu/L 4 hours All ages Male 39 – 308

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 31 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Volume Test Container Specimen Type Condition Reference Range Units TAT* (mL) Royal Blue K2 EDTA Trace Cobalt Serum 5 see report ug/L 21 days Metals (available from lab) Common Alpha Sub Unit Gold - No anticoagulant Serum 5 All 0 to 1 IU/L 28 days Conjugated Bilirubin Gold - No anticoagulant Serum 5 All 0 to 5 umol/L 4 hours Copper Royal Blue Serum 5 All 11 to 22 umol/L 21 days Cortisol Gold - No anticoagulant Serum 5 see report nmol/L 8 hours Red top – No anticoagulant, C-Peptide Serum 5 see report pmol/L 28 days no gel

up to 2 months 27 to 77 up to 1 year 14 to 34 up to 3 years 15 to 31 up to 5 years 23 to 37 up to 7 years 25 to 42 Creatinine Gold - No anticoagulant Serum 5 up to 9 years 30 to 47 umol/L 4 hours up to 11 years 29 to 56 up to 13 years 39 to 60 up to 15 years 40 to 68 up to 128 years Female 49 to 92 up to 128 years Male 66 to 112

CRP Gold - No anticoagulant Serum 5 All 0 to 5 mg/L 4 hours Please contact the Cryoglobulins Serum & Plasma 5 n/a n/a 7 days laboratory. Cyclosporin Lavender - EDTA Whole blood 4 All 100 to 300 ug/L 7 days

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 32 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Volume Test Container Specimen Type Condition Reference Range Units TAT* (mL)

up to 1 year Female 0.09 to 3.35 up to 1 year Male 0.09 to 3.35 up to 4 years Female 0.01 to 0.53 up to 4 years Male 0.01 to 0.53 up to 10 years Female 0.08 to 2.31 up to 10 years Male 0.08 to 2.31 up to 14 years Female 1.48 to 6.92 up to 14 years Male 1.34 to 6.65 up to 19 years Female 1.81 to 8.3 up to 19 years Male 3.61 to 15 up to 24 years Female 4.29 to 11.2 up to 24 years Male 5.7 to 13.5 DHEAS Gold - No anticoagulant Serum 5 umol/L 14 days up to 34 years Female 2.66 to 8.55 up to 34 years Male 4.42 to 11.5 up to 44 years Female 1.65 to 9.17 up to 44 years Male 2.99 to 11.5 up to 54 years Female 0.96 to 6.95 up to 54 years Male 1.2 to 8.71 up to 64 years Female 0.51 to 5.56 up to 64 years Male 1.4 to 8.28 up to 74 years Female 0.26 to 6.68 up to 74 years Male 0.91 to 3.8 up to 128 years Female 0.33 to 4.18 up to 128 years Male 0.44 to 4.04

Digoxin Gold - No anticoagulant Serum 5 All 0.9 to 2 ug/L 8 hours

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 33 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Volume Test Container Specimen Type Condition Reference Range Units TAT* (mL) eGFR / 1.73m2 Gold - No anticoagulant Serum 5 over 18 years >90 mL/min 4 hours Ethosuximide Gold - No anticoagulant Serum 5 All 40 to 99 ug/mL 21 days Extracted Testosterone Gold - No anticoagulant Serum 5 see report nmol/L 28 days up to 49 years Female 0.2 to 7.1 Free Androgen Index Gold - No anticoagulant Serum 5 % 8 hours up to 128 years Female 0.1 to 5

up to 6 days 2.7 to 9.7 up to 3 month 3 to 9.3 up to 1 year 3.3 to 9.0 Free T3 Gold - No anticoagulant Serum 5 up to 6 years 3 to 9.1 pmol/L 2 Days up to 11 years 4.1 to 7.9 up to 19 years 3.5 to 7.7 up to 128 years 3.1 to 6.8

up to 6 days 11 to 32 up to 3 month 12 to 28 up to 1 year 12 to 26 up to 6 years 11 to 23 Free T4 Gold - No anticoagulant Serum 5 pmol/L 8 hours up to 11 years 12 to 22 up to 19 years 12 to 21 up to 128 years 12 to 22 Pregnancy Contact Laboratory

Fructosamine Gold - No anticoagulant Serum 5 All 205 to 285 umol/L 4 days Female 3.5 to 12.5 FSH Gold - No anticoagulant Serum 5 iu/L 8 hours Male 1.5 to 12.4

Female 6 to 42 Gamma GT Gold - No anticoagulant Serum 5 iu/L 4 hours Male 10 to 71 Gastrin Lavender - EDTA Plasma 4 All 0 to 40 pmol/L 21 days

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 34 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Volume Test Container Specimen Type Condition Reference Range Units TAT* (mL) Glucagon Lavender - EDTA Plasma 4 All 0 to 50 pmol/L 21 days

Fasting 3 to 5.5 Glucose Grey - Fluoride Oxalate Plasma 2 mmol/L 4 hours Random 3 to 7.8

Growth Hormone Gold - No anticoagulant Serum 5 see report ug/L 14 days Haptoglobins Gold - No anticoagulant Serum 5 All 0.3 to 2.0 g/L 14 days HbA1c Lavender - EDTA Blood 4 All 20 to 41 mmol/mol 48 hours HDL Cholesterol Gold - No anticoagulant Serum 5 see report mmol/L 8 hours Homocysteine Lavender - EDTA Plasma 4 All 5.2 to 15.1 umol/L 14 days up to 1 year 0 to 0.83 up to 4 years 0.2 to 1.0 up to 7 years 0.27 to 1.95 up to 10 years 0.34 to 3.05 IgA Gold - No anticoagulant Serum 5 up to 12 years 0.53 to 2.04 g/L 12 hours up to 14 years 0.58 to 3.58 up to 16 years 0.47 to 2.49 up to 20 years 0.61 to 3.48 up to 128 years 0.7 to 4.0

IGF-1 Gold - No anticoagulant Serum 5 see report nmol/L 21 days

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 35 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Volume Test Container Specimen Type Condition Reference Range Units TAT* (mL) up to 1 year 2.3 to 14.1 up to 4 years 4.5 to 9.2 up to 7 years 5 to 14.6 up to 10 years 5.7 to 14.7 IgG Gold - No anticoagulant Serum 5 up to 12 years 7 to 15.6 g/L 12 hours up to 14 years 7.6 to 15.5 up to 16 years 7.2 to 17.1 up to 20 years 5.5 to 15.8 up to 128 years 7 to 16

IgG Subclasses Gold - No anticoagulant Serum 5 see report n/a 21 days

IgG/Transferrin Ratio Gold - No anticoagulant Serum 5 see report ratio 21 days up to 1 year 0 to 1.45 up to 4 years 0.19 to 1.46 up to 7 years 0.24 to 2.1 up to 10 years 0.31 to 2.08 IgM Gold - No anticoagulant Serum 5 up to 12 years 0.31 to 1.79 g/L 12 hours up to 14 years 0.35 to 2.39 up to 16 years 0.15 to 1.88 up to 20 years 0.23 to 2.59 up to 128 years 0.4 to 2.3

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 36 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Volume Test Container Specimen Type Condition Reference Range Units TAT* (mL)

Immunofixation Gold - No anticoagulant Serum 5 n/a n/a 14 days

Red top – No anticoagulant, Insulin Serum 5 All 3 to 17 mu/L 28 days no gel Female 6.6 to 26.0 Iron Gold - No anticoagulant Serum 5 umol/L 8 hours Male 8.1 to 28.3

Lactate Grey - Fluoride Oxalate Plasma 2 All 0.5 to 2.2 mmol/L 4 hours

Lamotrigine Gold - No anticoagulant Serum 5 All 1 to 15 mg/L 16 days LDH Gold - No anticoagulant Serum 5 All < 250 iu/L 8 hours LDL Cholesterol Gold - No anticoagulant Serum 5 see report mmol/L 4 hours Lavender – EDTA (Also requires an empty Lead Plasma 4 All 0 to 0.49 umol/L 14 days tube from the same batch to act as a blank) Levetiracetam Gold - No anticoagulant Serum 5 see report mg/l Female 2.4 to 12.6 LH Gold - No anticoagulant Serum 5 iu/L 8 hours Male 1.7 to 8.6

Lithium Gold - No anticoagulant Serum 5 All 0.4 to 1.0 mmol/L 24 hours

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 37 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Volume Test Container Specimen Type Condition Reference Range Units TAT* (mL) up to 16 years 0 – 51 Liver ALP Gold - No anticoagulant Serum 5 up to 128 years –Female 0 – 45 u/L 21 days up to 128 years –Male 0 - 64 Macroprolactin Gold - No anticoagulant Serum 5 n/a n/a 10 days Magnesium Gold - No anticoagulant Serum 5 All 0.65 to 1.05 mmol/L 4 hours Mercury Lavender - EDTA Whole blood 5 All 0 to 30 nmol/L 14 days Neurotensin Lavender - EDTA Plasma 4 All 0 to 100 pmol/L 21 days NT-proBNP Gold - No anticoagulant Serum 5 All 0 to 400 ng/L 4 days (available to GPs only) Female(Follicular) 45 to 854 Female(ovulation) 151 to 1461 Oestradiol Gold - No anticoagulant Serum 5 pmol/L 8 hours Female(Luteal) 82 to 1251 Male 41 to 159

Osmolality Gold - No anticoagulant Serum 5 All 275 to 295 mosmol/kg 12 hours

10-Hydroxycarbazepine Gold - No anticoagulant Serum 5 see report ng/l P. Polypeptide Lavender - EDTA Plasma 4 All 0 to 300 pmol/L 21 days Paracetamol Gold - No anticoagulant Serum 5 All 0 to 15 mg/L 4 hours Phenobarbitone Gold - No anticoagulant Serum 5 All 15 to 40 mg/L 8 hours Phenytoin Gold - No anticoagulant Serum 5 All 10 to 20 mg/L 8 hours

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 38 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Volume Test Container Specimen Type Condition Reference Range Units TAT* (mL) Male – Female – Age mmol/L mmol/L 1 – 30 days 1.25 – 2.25 1.40 – 2.50 1 – 12 months 1.15 – 2.15 1.20 – 2.10 1 – 3 years 1.00 – 1.95 1.10 – 1.95 Phosphate Gold - No anticoagulant Serum 5 4 – 6 years 1.05 – 1.80 1.05 – 1.80 mmol/L 4 hours 7 – 9 years 0.95 – 1.75 1.00 – 1.80 10 – 12 years 1.05 – 1.85 1.05 – 1.70 13 – 15 years 0.95 – 1.65 0.90 – 1.55 16 – 18 years 0.85 – 1.60 0.80 – 1.55 ≥ 19 years 0.81 – 1.45

Green - Lithium Heparin (adult) Plasma Amino Acids Plasma 5 see report n/a 21 days Orange – Lithium Heparin (Paediatric)

NICU 3.6 to 6.1 up to 1 year 3.6 to 5.5 Potassium Gold - No anticoagulant Serum 5 mmol/L 4 hours up to 18 years 3.1 to 5.1 up to 128 years 3.5 to 5.1

Primidone Gold - No anticoagulant Serum 5 All 0 to 13 mg/L 21 days

Procollagen III Gold - No anticoagulant Serum 5 All 1.2 to 4.2 ug/L 21 days

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 39 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Volume Test Container Specimen Type Condition Reference Range Units TAT* (mL) Progesterone Gold - No anticoagulant Serum 5 see report nmol/L 8 hours Pro-Insulin Green - Lithium Heparin Plasma 5 see report n/a 28 days Female 102 to 496 Prolactin Gold - No anticoagulant Serum 5 mu/L 8 hours Male 86 to 324

Protein Electrophoresis Gold - No anticoagulant Serum 5 n/a n/a 6 days

Female n/a up to 40 years Male 0 to 1.4 up to 50 years Male 0 to 2.0 PSA Gold - No anticoagulant Serum 5 ug/L 8 hours up to 60 years Male 0 to 3.9 up to 70 years Male 0 to 5.4 up to 128 years Male 0 to 6.2

PTH Gold - No anticoagulant Serum 5 All 1.6 to 6.9 pmol/L 24 hours

Renin Lavender - EDTA Plasma 4 see report nmol/h/L 21 days Salicylate Gold - No anticoagulant Serum 5 All 0 to 40 mg/L 4 hours up to 1 day 0.48 to 1.19 Royal Blue – Trace Metals up to 6 months 0.36 to 0.46 Selenium Serum 5 up to 2 year 0.32 to 0.63 umol/L 21 days (available from lab) up to 15 years 0.57 to 0.90 up to 128 years 0.89 to 1.65 up to 49 years Female 19.1 to 145 up to 49 years Male 15.4 to 63.8 SHBG Gold - No anticoagulant Serum 5 nmol/L 8 hours up to 128 years Female 14.4 to 136 up to 128 years Male 14.2 to 78

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 40 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Volume Test Container Specimen Type Condition Reference Range Units TAT* (mL) up to 1 month 132 to 147 up to 1 year 132 to 143 Sodium Gold - No anticoagulant Serum 5 mmol/L 4 hours up to 18 years 132 to 145 up to 128 years 135 to 145

Somatomedin C Gold - No anticoagulant Serum 5 see report nmol/L 28 days

Tacrolimus FK506 Lavender - EDTA Whole blood 4 All 5 to 15 ug/L 7 days up to 50 years Male 7.6 to 31.4 Testosterone Gold - No anticoagulant Serum 5 up to 128 years Female 0.1 to 1.8 nmol/L 8 hours up to 128 years Male 4.6 to 31.2

Theophylline Gold - No anticoagulant Serum 5 All 10 to 20 mg/L 8 hours

Thyroglobulin Gold - No anticoagulant Serum 5 All 0 to 40 ug/L 21 days Thyroid Binding Glob Gold - No anticoagulant Serum 5 All 7 to 17 mg/L 28 days Thyroid Receptor Antibodies Gold - No anticoagulant Serum 5 All 0 to 10 u/L 28 days TIBC Gold - No anticoagulant Serum 5 All 40.8 to 76.6 umol/L 8 hours Total CO2 Gold - No anticoagulant Serum 5 All 22 to 29 mmol/L 4 hours up to 1 day 34 to 50 up to 1 month 46 to 68 Total Protein Gold - No anticoagulant Serum 5 up to 1 year 48 to 76 g/L 4 hours up to 18 years 60 to 80 up to 128 years 66 to 87

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 41 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Volume Test Container Specimen Type Condition Reference Range Units TAT* (mL)

TPMT Lavender - EDTA Whole Blood 4 All 26 to 50 pmol/h/mgHb 21 days

TPO Antibodies Gold - No anticoagulant Serum 5 All 0 to 34 iu/mL 8 hours Transferrin Gold - No anticoagulant Serum 5 see report n/a 21 days Transferrin Saturation Gold - No anticoagulant Serum 5 see report % 8 hours Triglycerides Gold - No anticoagulant Serum 5 Fasting 0 to 2.2 mmol/L 8 hours Troponin-T Gold - No anticoagulant Serum 5 All 0 – 14 ng/L 4 hours Tryptase (Mast Cell) Gold - No anticoagulant Serum 5 All 2 to 14 ug/L 21 days up to 3 days 5.2 to 14.6 up to 1 year 0.6 to 8.1 up to 6 years 0.5 to 4.5 TSH Gold - No anticoagulant Serum 5 mu/L 8 hours up to 11 years 0.7 to 4.1 up to 19 years 0.5 to 3.6 up to 128 years 0.3 to 4.2

Female 0.14 to 0.34 Urate Gold - No anticoagulant Serum 5 mmol/L 4 hours Male 0.2 to 0.42

up to 1 year 1.4 to 6.8 up to 18 years 1.8 to 6.4 Urea Gold - No anticoagulant Serum 5 mmol/L 4 hours up to 60 years 2.1 to 7.1 up to 128 years 2.9 to 8.2

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 42 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Volume Test Container Specimen Type Condition Reference Range Units TAT* (mL)

V.I.P. Lavender - EDTA Plasma 4 All 0 to 30 pmol/L 21 days

Valproic Acid Gold - No anticoagulant Serum 5 All 50 to 100 mg/L 8 hours Very Long Chain Fatty Acids Gold - No anticoagulant Serum 5 see report see report 28 days Vigabatrin Gold - No anticoagulant Serum 5 see report umol/l Gold - No anticoagulant up to 1 years 0.5 to 1.5 Vitamin A Serum 5 up to 6 years 0.7 to 1.5 umol/L 21 days (protect from light) up to 128 years 0.8 to 3.6

Deficiency <25 Insufficiency 25-75 Vitamin D Gold - No anticoagulant Serum 5 nmol/L 21 days Sufficiency 76-250 Toxicity >250

up to 1 year 4.6 to 14 Vitamin E Gold - No anticoagulant Serum 5 up to 13 years 9.0 to 28 umol/L 28 days up to 128 years 11.6 to 35.5 Zinc Royal Blue Serum 5 All 11.5 to 17 umol/L 21 days

URINE

Timed 24 hour See above for dietary Urine 5-HIAA excretion 24 hour + Preservative n/a 0 to 50 umol/d 21 days collection restrictions Timed 24 hour See above for dietary Urine 5-HIAA/Creat Ratio 24 hour + Preservative n/a 0 to 4.9 umol/mmol 21 days collection restrictions Urine Albumin/Creat Ratio Female 0 to 3.5 Universal container Mid Stream 20 mg/mmol 24 hours (ACR) Male 0 to 2.5

Urine Amino Acids Universal container Mid Stream 20 see report n/a 21 days

Urine Amylase Universal container Mid Stream 20 see report u/L 4 days Urine Bence Jones Protein Universal container Early Morning 20 n/a n/a 6days

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 43 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Volume Test Container Specimen Type Condition Reference Range Units TAT* (mL) Urine Cadmium/Creat Universal container Mid Stream 20 see report nmol/mm 14 days Timed 24 hour Urine Calcium excretion 24 Hour n/a All 2.5 to 8 mmol/d 24 hours collection Timed 24 hour Urine Calcium/Creat 24 Hour collection n/a see report n/a 24 hours Clearance Ratio Gold - No anticoagulant Serum Urine Calcium/Creat Ratio Universal container Mid Stream 20 up to 18 years 0.1 to 0.7 mmol/mm 24 hours (paediatric only) Timed 24 hour Please note on request Urine Catecholamines 24 hour + Preservative n/a See report See report 21 days collection form Patients medication Timed 24 hour Urine Citrate excretion 24 Hour + Preservative n/a All 0.6 to 4.8 mmol/d 21 days collection Timed 24 hour Urine Copper excretion 24 Hour n/a All 0 to 1 umol/d 21 days collection Timed 24 hour Urine Cortisol excretion 24 Hour n/a All 100 to 379 nmol/d 8 days collection Timed 24 hour 24 Hour Urine Creatinine Clearance collection n/a All 90 to 130 mL/min 24 hours Gold - No anticoagulant Serum Timed 24 hour Female 7 to 14 Urine Creatinine excretion 24 Hour n/a mmol/d 24 hours collection Male 9 to 21

Urine Cystine Universal container Mid Stream 20 n/a n/a 12 days

Urine Drugs of Abuse Universal container Mid Stream 20 n/a n/a 14 days Urine Fixation Universal container Early Morning 20 n/a n/a 14 days Urine GAG/Creatinine ratio Universal container Mid Stream 20 see report see report 42 days Timed 24 hour Urine Glycollate excretion 24 Hour n/a All 140 to 620 mmol/d 21 days collection Urine Mercury/Creat Universal container Mid Stream 20 All 0 to 5 nmol/mmol 14 days Urine Mucopolysaccharides Universal container Mid Stream 20 n/a n/a 42 days

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 44 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Volume Test Container Specimen Type Condition Reference Range Units TAT* (mL) Urine Organic Acids Universal container Mid Stream 20 see report n/a 35 days Urine Osmolality Universal container Mid Stream 20 All 50 to 1400 mosmol/kg 12 hours Timed 24 hour Urine Oxalate excretion 24 hour + Preservative n/a All 100 to 460 umol/d 28 days collection Urine pH Universal container Mid Stream 20 All 4.5 to 8 6 hours Timed 24 hour Urine Phosphate excretion 24 Hour n/a All 13 to 42 mmol/d 24 hours collection Urine Phosphate/Creat Ratio Universal container Mid Stream 20 All 0.443 to 3.33 mmol/mmol 24 hours Universal container(protect Urine Porphobilinogen Mid Stream 20 n/a n/a 24 hours from light) Urine Porphyrins Mid Stream Universal container 20 n/a n/a 24 hours (screen) (during attack) Urine Potassium (spot) Universal container Mid Stream 20 see report mmol/L 24 hours Timed 24 hour Urine Potassium excretion 24 Hour n/a All 25 to 125 mmol/d 24 hours collection Timed 24 hour Urine Protein excretion 24 Hour n/a All 0 to 0.15 g/d 24 hours collection Urine Protein/Creat Ratio Universal container Mid Stream 20 All 0 to 30 mg/mmol 24 hours (PCR) Urine Sodium (spot) Universal container Mid Stream 20 All 0 to 300 mmol/L 24 hours Timed 24 hour Urine Sodium excretion 24 Hour n/a All 40 to 220 mmol/d 24 hours collection Timed 24 hour Urine Steroid Profile 24 Hour n/a see report n/a 21 days collection Timed 24 hour Urine Urate excretion 24 Hour n/a All 1.2 to 5.9 mmol/d 24 hours collection Timed 24 hour Urine Urea excretion 24 Hour n/a All 170 to 580 mmol/d 24 hours collection Urine VMA Spot Mid Stream n/a All 0 to 10 Umol/mmol 1 month

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 45 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Volume Test Container Specimen Type Condition Reference Range Units TAT* (mL)

CSF

CSF Glucose Grey - Fluoride Oxalate CSF 2 All 2.2 to 4.4 mmol/L 4 hours CSF Lactate Grey - Fluoride Oxalate CSF 2 All 1.1 to 2.4 mmol/L 4 hours CSF LDH Universal container CSF 2 All 0 to 26 iu/L 4 hours CSF Oligoclonal Bands Universal container / Gold CSF/Serum 2/6 n/a n/a 21 days CSF Protein Universal container CSF 2 All 0.15 to 0.45 g/L 4 hours CSF Xanthochromia Universal container-covered CSF 2 n/a n/a 24 hours

FLUIDS

Fluid Albumin Universal container Fluid 5 n/a 4 hours Fluid Amylase Universal container Fluid 5 n/a umol/L 4 hours Fluid Calcium Universal container Fluid 5 n/a mmol/L 4 hours Fluid Cholesterol Universal container Fluid 5 n/a mmol/L 4 hours Fluid Creatinine Universal container Fluid 5 n/a umol/L 4 hours Fluid Glucose Grey - Fluoride Oxalate Fluid 2 n/a mmol/L 4 hours Fluid LDH Universal container Fluid 5 n/a iu/L 4 hours Blood gas syringe Fluid pH Fluid 2 n/a 30 minutes (bring directly to lab) Fluid Potassium Universal container Fluid 5 n/a mmol/L 4 hours Fluid Protein Universal container Fluid 5 n/a g/L 4 hours Fluid Sodium Universal container Fluid 5 n/a mmol/L 4 hours Fluid Triglycerides Universal container Fluid 5 n/a mmol/L 4 hours Fluid Urate Universal container Fluid 5 n/a mmol/L 4 hours Fluid Urea Universal container Fluid 5 n/a mmol/L 4 hours

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 46 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Volume Test Container Specimen Type Condition Reference Range Units TAT* (mL)

FAECES

Faecal Elastase Faeces container Stool 10 g see report n/a 21 days Faecal Occult Blood Faeces container Stool 10 g see report n/a 6 days Faecal Calprotectin Faeces container Stool Pea size see report mg/kg 14 days Faeces container(protect Faecal Porphyrin Stool 10 g see report n/a 21 days from light)

OTHER

Stone Analysis 60 ml plastic Pot Stone see report 14 days As Sweat Chloride Plastic conical tube Sweat see report mmol/L 4 days collected As Sweat Sodium Plastic conical tube Sweat see report mmol/L 4 days collected Toxicology Discuss with laboratory Discuss with laboratory n/a see report n/a 28 days (samples will be saved)

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 47 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

BIOCHEMISTRY DEPARTMENT REFERENCE LABORATORIES

Hospital Location Laboratory Charing Cross Hospital Fulham Palace Road London Medical Oncology Great Ormond Street Hospital Lambs Conduit Street London Virology Camelia Botnar Laboratory Great Ormond Street Hospital Great Ormond St London Chemical Pathology Hospital for Sick Children Guy’s Hospital St Thomas Street London Purine Research Lab Hammersmith Hospital Du Cane Road London Clinical Chemistry Institute of Child Health Guildford St London Enzyme Laboratory King’s College Hospital Denmark Hill London Clinical Biochemistry National Hospital Queens Square London Neuroimmunology Rotherham Hospital Moorgate Road Rotherham Clinical Biochemistry Royal Brompton Hospital Sidney Street London Biochemistry Royal Free Hospital Pond Street Hampstead Clinical Biochemistry Royal Liverpool Hospital Prescot Street Liverpool Endocrinology Royal Newcastle Infirmary Queen Victoria Road Newcastle Upon Tyne SAS Laboratory SAS Steroid Hormone Centre Thoresby Place Leeds Clinical Chemistry Selly Oak Hospital Raddlebarn Road Birmingham Clinical Biochemistry Sheffield PRU PO Box 894 Sheffield Immunology St. Bartholomew’s Newark Street London Clinical Biochemistry St James' University Hospital Beckett Street Leeds Biochemistry St Thomas' Hospital Westminster Bridge Road London Chemical Pathology UCLH/Middx Hospital Whitfield Street London Chemical Pathology

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 48 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

HAEMATOLOGY

The Haematology department offers a wide range of investigations including cellular haematology, coagulation, and blood transfusion and haemoglobinopathy studies. Many low demand assays and more specialised investigations such as cell-markers and thrombophilia screens are referred to reference laboratories for analysis. Reports on these tests are slower since time must be allowed for transport of the sample and most laboratories will batch analyses. A list of reference laboratories used by the laboratory is included in this guide. The analysing laboratory is always displayed with results.

TELEPHONE NUMBERS

One of our haematology staff is available at all times to offer advice on appropriate investigations and interpretation of results. Consultants: Dr Bernard Davies: 0207 288 3730 Dr Farrukh Shah: 0203 602 2965 Dr Ali Rismani: 07881821762 Dr Emma Drasar: 0207 288 5034 Dr Zara Sayar : 0207 288 5791 Dr Ryan Mullally: 0207 288 5791 Dr Annie Mcmillan: 0207 288 5791

Registrars: 020 7288 5756 Service Manager: 020 7288 5043 Haematology Lab (technical queries ONLY): 020 7288 5037 Blood Transfusion Lab: 020 7288 5762 Results: 020 7288 5775 On Call Biomedical Scientist: Bleep 2686

URGENT REQUESTS

Most tests can be prioritised in exceptional circumstances: please contact the laboratory. Use of the priority flag on Sunquest ICE requests should ensure that samples are processed more rapidly. ON-CALL SERVICE

An on-call service operates at all times outside routine working hours. This is covered by a single member of staff who covers both Haematology and Blood Transfusion. Requests should be restricted to those tests affecting immediate patient management. After midnight urgent requests must be arranged in advance with the Duty Haematology Scientist by bleeping 2686. Samples will otherwise be analysed with the next batch – usually within a couple of hours. It is not possible for telephone extensions within the department to be manned out of hours. The following tests can normally be arranged out of hours: Full Blood Count, Reticulocytes, Coagulation Screen, INR, APTT, ESR , Malaria Parasites , Sickle Solubility test and blood films if indicated.

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 49 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Other tests may be available on discussion with the on-call Haematology Scientist or senior member of staff on duty. RESULTS

HAEMOGLOBINOPATHY SERVICE

The haematology department runs a comprehensive haemoglobinopathy service that includes diagnosis and management. This also includes the antenatal and new born (ANNB) Screening Programme for sickle cell and Thalasaemia. The SCT programme offers screening to pregnant women and couples to find out if they are at risk of having a baby with sickle cell disease or thalassaemia major, which are serious inherited blood conditions. Screening also aims to improve infant health through prompt identification and treatment of affected babies. For more information visit;https://www.gov.uk/government/collections/nhs-population- screening-programme-standards#sickle-cell-and-thalassaemia-(sct)-screening.

The technology employed in the identification of haemoglobin variants is HPLC. Reports on POSITIVE results include information leaflets for the patient and the doctor along with a Haemoglobinopathy Card for the patient to carry at all times. This card should be shown to any doctor, dentist or midwife that the patient consults. All the Haematology consultants manage patients with haemoglobinopathies through their outpatient clinics and as inpatients .A counselling service is available for patients with haemoglobin variants – 0203 316 8853/8854. TOP TEN HAEMATOLOGICAL INVESTIGATIONS

Iron Deficiency Anaemia This affects one in five hundred males and one in twenty females. Patients often cope extremely well with quite severe anaemia, especially when the problem has developed slowly. If the FBC and film results are clear cut there is really no need for further laboratory investigations but if in doubt check Iron / IBC. In children and adolescents iron deficiency is most often due to poor diets. Coeliac disease should also be considered. In young women, menorrhagia is the commonest cause of iron deficiency, judging the degree of menorrhagia can be extremely difficult. In men, post-menopausal women and younger women with no menorrhagia it is absolutely essential that the cause of the iron deficiency be investigated. There may be a relevant history e.g. abdominal pain, suggestive of duodenal ulcer or change in bowel habit, suggestive of underlying carcinoma. Symptoms should guide the choice of first investigation but the majority of patient will require a careful history, upper G.I. endoscopy, sigmoidoscopy and Barium Enema. They can be referred either direct to the gastroenterologist, to a G.I. surgeon or to the Haematology Department, all of whom can work

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 50 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021 together to ensure that we don’t miss potentially treatable causes of iron deficiency, e.g. carcinoma of the caecum. Sickle Cell Trait Sickle cell trait is mainly seen in people of African and Caribbean extraction. The gene is recognised in a range of other groups, in our local population the Cypriot community can be affected. We would encourage all ethnic minority groups of childbearing age to know their haemoglobinopathy status. You need to be aware that sickle cell can be seen as a stigmatising problem in the Afro-Caribbean community. Patients may “forget” their status or deny it. There is a lot of mythology around - including the possibility of sickle cell trait changing to sickle cell anaemia or that it can be caught. Patients with sickle cell trait should be haematologically normal. For further information patients can be referred to the Sickle / Thalassaemia Counsellors on 020 7530 2050. Beta Thalassaemia Trait Beta thalassaemia trait is most common in the Cypriot community but can affect virtually all other racial groups. It can be important in the African and Caribbean communities. Remember that one parent with sickle cell trait and one with beta thalassaemia trait can give birth to a child who has sickle beta thalassaemia that can be clinically indistinguishable from sickle cell anaemia. Beta thalassaemia trait is easy to diagnose, there will be a minimal anaemia or no anaemia but a hypochromic, microcytic blood picture, usually without anisocytosis. The Hb A2 level is characteristically raised above 3.5% of the total adult haemoglobin. Alpha Thalassaemia Trait This is extremely common in our local population and occurs in all racial groups. There is even a variant that is specific to people from northern Europe. The diagnosis initially is one of exclusion. There is no simple diagnostic test to prove the presence of  thalassaemia trait. There will be a minimal anaemia at worst. The MCH can vary from just below 27pg or lower depending on the type of  thalass-aemia trait. It is usual to do a ferritin or serum iron and total iron binding to exclude the possibility of iron deficiency. The haemoglobin A2 quantitation will be normal or slightly reduced.  thalassaemia trait causes no problems for the carrier but can be of extreme importance in couples, both of whom are missing two of the normal four genes for  chains (alpha zero trait). If the two genes are missing from both chromosome, then the child may have alpha thalassaemia major, this will cause hydrops foetalis and normally death in utero or shortly after birth. This is most common in people from Cyprus and South East Asia. It is normally best to refer these patients for further counselling to 020 7530 2050. In these extreme cases it may be necessary to do DNA studies to prove exactly what the genetic mutation is. The DNA sample is normally sent to Oxford for analysis. Neutropenia The reference ranges for neutrophil counts only apply to northern European populations. Many totally healthy African and Caribbean people have neutrophil counts between 1.0 and 2.0 x 109/l. which, while low against the reference range, is completely acceptable. Mild neutropenia is common with viral illnesses. Neutrophils below 1.0 x 109/l. should always be re- checked, preferably within a week or two. If the patient is sick with a low neutrophil count then they ought to be referred straight to A & E. The combination of neutropenia with other problems (e.g. mild anaemia or a low platelet count) ought also to result in urgent referral. Macrocytosis Slightly high mean cell volumes are a common finding in the normal population. It is always more worrying if it is associated with either anaemia or other disturbances in white cells or platelets. Before referral it is worthwhile checking the history for alcohol consumption. Check B12 and folate, abnormalities of liver function tests and thyroid disease can both present with macrocytosis.

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 51 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

If there is significant anaemia, thrombocytopenia or leucopenia the patient almost certainly needs a bone marrow. Of the disorders that can present with these multiple abnormalities, B12 and folate deficiency (SEE 8 BELOW) are the only ones with a really good prognosis. Thrombophilia Since the discovery of factor V leiden in 1994 there has been an increasing tendency to request screening on patients who have a strong family history of deep vein thrombosis. Factor V leiden affects about one in twenty of our population. These tests (including Lupus anticoagulant and Anti- cardiolipin) are expensive, costing about £250 a time, they are not yet available as open access tests. Their use should be restricted to patients with a strong history of thrombotic episodes or women with repeated miscarriages. NOTE: THE RESULTS ARE AFFECTED BY WARFARIN. Patients need to think carefully of the negative consequences of being tested. Many women who have been satisfactorily on the pill for several years have had that treatment stopped as a consequence of positive screens. That may not be sensible since pregnancy causes more thromboses than the pill. This is an issue that requires referral and further thought before any tests are done. Vitamin B12 We are often asked to do Vitamin B12 levels on people taking replacement therapy. That is an unnecessary investigation. People who have true pernicious anaemia should have quarterly injections of B12 and if they stick with that regime will not develop clinical B12 deficiency. They may be at increased risk of iron deficiency. They lack the ability to secrete acid and therefore can malabsorb iron. They are also at increased risk of carcinoma of the stomach so iron deficiency could be an indicator of a major problem. Other situations in which B12’s are often misused is in late pregnancy where at least twenty-five per cent of women will have a low B12 with no clinical problems. They can be misdiagnosed as pernicious anaemia if the B12 is measured at that time. Macrocytosis is “normal” in pregnancy. The majority of women will have a rise in the MCV during pregnancy and this can climb above the reference range. Beware of misdiagnosing pernicious anaemia at that stage. Remember that people with pernicious anaemia are more likely to develop thyroid problems, it is worthwhile watching out for that since it is such a common association. Vegetarians can also have slightly low B12’s, normally that is not associated with any problems. It does not necessarily mean that the patient either needs referral or further investigation but you may need to talk to them about the low B12 and watch that they don’t develop either neuropathy or macrocytosis. Easy Bruising Easy bruising is a common complaint. Some of these patients don’t have bruises but actually have erythema nodosum and it is worthwhile being on the lookout for painful bruise like lesions, especially over the shins. Purpura is always a worry, obviously in a sick patient one has to think of meningococcal septicaemia but from the haematologists viewpoint it most often indicates a low platelet count. Bigger bruises are usually the result of trauma. As people get older they bruise more easily because of changes in collagen around the blood vessels. Remember that Aspirin and some other non-steroidals can increase the risk of bruising. Routine clotting screen plus a platelet count will uncover virtually all truly significant bleeding disorders. A few cases of Von Willebrand’s will not be shown up by these tests and those would require referral for further investigation. A rarity that causes great excitement in haematology departments is scurvy which, regrettably, we still do see. It is quite remarkable how poorly some of our population eat. ESR The ESR is often over-requested. It is extremely useful as a tool for monitoring progress of treatments in people with chronic disorders such as rheumatoid, it is essential if you think the patient might have polymyalgia. It is not a good screening test for people where you think there might be a malignancy.

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 52 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

People can and do die of disseminated malignant disease while still having a normal ESR. If you have done an ESR and have a reasonably well patient with an ESR in the 20 – 50 range it can be a particular diagnostic problem. In general if the patient is well, it is probably best to leave them alone. In the over fifties one could do protein electrophoresis as the next test. Overall, if the history doesn’t give an indication of where the problem is, a moderately raised ESR can be a big nuisance. Need some advice from a member of the clinical staff? We will sometimes telephone you when we have discovered a very significant abnormality. Sometimes there will be relatively minor problems that you want us to explain in greater detail. If you need advice within the next twenty-four hours why not send us a quick e-mail ? Contact details: . Dr Davis - [email protected] . Dr Shah - [email protected] . Dr Rismani - [email protected] . Dr Drasar - [email protected] . Dr Zara Sayar - [email protected] . Dr Ryan Mullally- [email protected] . Dr Annie Mcmillan- [email protected]

HAEMATOLOGY TIME LIMITS FOR REQUESTING ADD ON TESTS

The following add-on tests can be accepted within the time limits. These time limits assume that the sample was not initially haemolysed, underfilled, clotted or lipaemic and that the sample was originally taken into the correct container as listed elsewhere in this handbook. The information is based on manufacturer’s information (when available) and on the document: To add a test or for further advice please contact the laboratory on 020 288 5775 or bleep 2686 out of hours. Non urgent add ons Note that the laboratory only retains FBC samples for about 10 days and coagulation samples for 24 hrs.

ADD ON TEST ESR 12 HRS BLOOD FILM 12 HRS MALARIA PARASITE 12 HRS D-DIMER FOR QUERY DVT/PE (WHOLE 4 HRS BLOOD) GLANDULAR FEVER TEST 3 DAYS HB ELECTROPHORESIS 7 DAYS SICKLE SOLUBILITY TEST 7 DAYS RETICULOCYTES 1 DAY

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 53 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

G6PD SCREEN 7 DAYS

FACTORS THAT CAN AFFECT SAMPLE INTEGRITY

EDTA Samples that are clotted or insufficient are not acceptable for Full Blood Count, Reticulocytes, ESR, HB Electrophoresis, G6PD Screen, Sickle Solubility Test, GF Test , Malaria Parasite or Manual Blood Films. CITRATE Samples that are clotted or under filled are not acceptable for Coagulation Test ( INR, APTT and Fibrinogen) and Special Coagulation studies Prolonged venous stasis can cause samples to be clotted and also cause activated samples for coagulation tests. Grossly Haemolysed Samples are not acceptable for Coagulation Tests.

HAEMATOLOGY TEST GUIDE

For further details please contact the laboratory on extension 5775. Key Tests Not all of the tests listed are available routinely. Container All samples should be sent to the laboratory as promptly as possible: most assays will show some deterioration with time. In some instances rapid processing of the sample is essential: in the table below such assays are marked in blue. These samples must be brought directly to the laboratory and not left for routine collection. The laboratory uses the BD Vacutainer system for blood samples Reference Range Reference ranges for numeric tests are for guidance only: clinical decisions should always be based on the range printed on the report or transmitted electronically with the result. Units An entry of ‘n/a’ generally means a qualitative test which has no numeric reference range. TAT (Turnaround Time) This is the time in which the laboratory would expect to have a result available – from receipt of sample to availability of results for electronic enquiry (printed reports may take longer since they are batched). Turnaround can vary widely – particularly for tests sent to reference laboratories. In the event of an unreasonable delay please speak to a senior member of laboratory staff.

*TAT only applies to routine working days

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 54 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

TEST REPERTOIRE

SAMPLE SAMPLE SPECIAL PRECAUTIONS TIME LIMITS FOR REFERENCE TEST UNITS TYPE VOLUME INTERFERING FACTORS ADDITIONAL TESTS RANGE ANTI-CARDIOLIPINS CLOTTED 6ml Haemolysis No add-on tests Referral Test Referral Test ESR EDTA 4.0ml Under-filled samples 12 hrs if EDTA sample Less than 60 mm/hour Clots in sample. available from previous FBC years: 1-20 request. Greater than 60 years: 1-30 FBC EDTA 4.0ml Under-filled samples No add-on tests See Table 1 See Table Clots in sample. below FBC 1 below Reference FBC Ranges and Reference Units of Measure Ranges and Units of Measure RETICULOCYTES EDTA 4.0ml Under-filled samples 24 HRS Percentage :0.2 % Clots in sample. – 2.0 % 9 Absolute: .30- x 10 /L 100 GLANDULAR FEVER TEST EDTA 4.0 ML Under-filled samples 3 DAYS N/A N/A Clots in sample. COAGULATION TEST CITRATE 4.0ml Under-filled samples No add-on tests See Table (INR/APTT/FIBRINOGEN) Clots in sample. See Table 2 2 below: below: Coagulation Coagulation tests tests Reference Reference Ranges and Ranges Units of Measure and Units of Measure

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 55 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

SAMPLE SAMPLE SPECIAL PRECAUTIONS TIME LIMITS FOR REFERENCE TEST UNITS TYPE VOLUME INTERFERING FACTORS ADDITIONAL TESTS RANGE D-DIMER FOR QUERY CITRATE 4.0ml Under-filled samples Using whole blood 4 hrs. Negative D-dimer ng/mL FEU DVT/PE Clots in sample. is less than or equal to 250 ng/mL FEU. SICKLING TEST EDTA 4.0ml Under-filled samples 1 week if EDTA sample N/A N/A Clots in sample. available from previous FBC request. HAEMOGLOBINOPATHY EDTA 4.0ml Under-filled samples 1 week if EDTA sample N/A N/A SCREEN Clots in sample. available from previous FBC request. G6PD SCREEN EDTA 4.0ml Under-filled samples 1 week if EDTA sample Clots in sample. available from previous FBC N/A N/A request.

G6PD ASSAY EDTA 4.0ml Under-filled samples 1 week if EDTA sample 4.6 – 13.5 IU/gHb Clots in sample. available from previous FBC Referral tests request. BLOOD FILM EXAMINATION EDTA 4.0ml Under-filled samples 12hrs N/A N/A Clots in sample. Samples > 6hrs. MALARIA PARASITES EDTA 4.0ml Under-filled samples 12hrs N/A N/A Clots in sample. Samples > 6hrs.

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 56 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

SAMPLE SAMPLE SPECIAL PRECAUTIONS TIME LIMITS FOR REFERENCE TEST UNITS TYPE VOLUME INTERFERING FACTORS ADDITIONAL TESTS RANGE HAEMATINIC ASSAY CLOTTED 6ml Under-filled samples 2 days if serum available in B12: 197-771 ng / L Haemolysis Lab. Folate: 3.0 – 26.8 ug/L Ferritin : Female :13-150 ug/L Male: 30-400 ug/L PLASMA VISCOSITY EDTA 4.0ml Discuss with Haem SPR for No add-on tests 1.5 – 1.72 pascal suitability of request. Sample stored at RT. SPECIAL HAEMOSTASIS CITRATE 2.7ml Discuss with Haem SPR for No add-on tests Referral tests Referral STUDIES suitability of request and tests sample type / quantity. Samples sent urgently to lab. CYTOGENETIC STUDIES EDTA 4.0ml Not a routine test. No add-on tests. Referral tests Referral Available through Haem tests clinic. Discuss with SPR for suitability of request. IMMUNOPHENOTYPING EDTA 4.0ml Not a routine test. No add-on tests. Referral tests Referral Available through Haem tests clinic. Discuss with SPR for suitability of request. Samples stored @RT. ERYTHROPOIETIN LEVEL CLOTTED 6ml Not a routine test. No add-on tests 5 - 25 Iu/L Available through Haem clinic. Discuss with SPR for suitability of request.

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 57 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

SAMPLE SAMPLE SPECIAL PRECAUTIONS TIME LIMITS FOR REFERENCE TEST UNITS TYPE VOLUME INTERFERING FACTORS ADDITIONAL TESTS RANGE HFe GENE MUTATION EDTA 7ml Not a routine test. No add-on tests Referral tests Referral STUDIES FOR Available through Haem tests HAEMOCHROMATOSIS clinic. Discuss with SPR for suitability of request. BONE MARROW BONE N/A Not a routine test. No add-on tests N/A N/A EXAMINATION MARROW Available through Haematology clinic. Discuss with Haematology Consultant or SPR for suitability of request.

Table 1: FBC Reference Ranges and Units of Measure : Parameter Units Age Range - Male Range - Female 9 WBC x 10 /L Birth – 6 days 10 - 26 10 - 26 (see below for 7 days to 6 months 5 - 21 5 - 21 Differential ranges) 6 months – 4 years 6 - 15 6 - 15 4 years – 16 years 5 - 12 5 - 12 16 years + 3.5 - 12 3.5 - 12 12 RBC x 10 /L Birth - 3 months 4 - 6 4 - 6 3 months – 12 Months 3.2 - 4.8 3.2 - 4.8 1 year – 3 years 3.6 - 5.2 3.6 - 5.2 3 years – 16 years 4.1 - 5.5 4.1 - 5.5 16 + 4.5 - 6.5 3.8 - 5.8 Hb g/L Birth - 6 days 145 - 220 145 - 220

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 58 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

7 days – 3 months 140 - 195 140 - 195 3 months – 12 months 95 - 125 95 - 125 1 year – 3 years 110 - 140 110 - 140 3 years – 12 years 110 - 140 110 - 140 12 years – 16 years 115 - 155 115 - 155 16 years + 130 - 180 115 - 165 Hct l/l Birth - 3 months 0.44 - 0.64 0.44 - 0.64 3 months – 3 years 0.32 - 0.44 0.32 - 0.44 3 years – 16 years 0.36 - 0.44 0.36 - 0.44 16 years + 0.40 - 0.54 0.37 - 0.50 MCV fl Birth - 3 months 100 - 130 100 - 130 3 months – 12 months 85 - 100 85 - 100 1 year – 3 years 70 - 86 70 - 86 3 years – 12 years 73 - 89 73 - 89 12 years – 16 years 77 - 91 77 - 91 16 years + 80 - 100 78 - 100 MCH pg Birth - 3 months 31-37 31 - 37 3 months – 12 years 27 - 33 27 - 33 12 years – 16 years 23 - 31 23 - 31 16 years + 27 - 32 27 - 32 MCHC g/L All ages 310 - 360 310 - 360 9 Platelets x 10 /L All ages 140 - 400 140 - 400 Rdw All ages 11.5-16 11.5-16

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 59 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

WBC Differential Count Parameter Units Age Range - Male Range - Female 9 Neutrophils x 10 /L Birth - 3 days 5.0 - 13.0 5.0 - 13.0 3 days - 6 years 1.5 - 10.0 1.5 - 10.0 6 years – 10 years 1.50 - 8.0 1.50 - 8.0 10 years – 16 years 2.0 – 6.0 2.0 – 6.0

16 years + 1.7 – 7.5 1.7 – 7.5 9 Lymphocytes x 10 /L Birth - 3 days 2.0 - 7.5 2.0 – 7.5 3 days – 12 months 3.0 - 9.0 3.0 – 9.0 1 year – 6 years 4.0 - 10.0 4.0 – 10.0 6 years – 10 years 1.5 - 9.5 1.5 - 9.5 10 years – 16 years 1.5 - 7.0 1.5 - 7.0 16 years + 1.0 - 4.0 1.0 - 4.0 9 Monocytes x 10 /L Birth - 4 days 0.5 - 1.5 0.5 - 1.5 4 days - 10 years 0.3 - 1.1 0.3 - 1.1 10 years – 16 years 0.2 - 1.2 0.2 - 1.2 16 years + 0.2 – 1.0 0.2 – 1.0 9 Eosinophils x 10 /L Birth-3 days 0.1 - 2.0 0.1 - 2.0 6 years 0.1 - 1.0 0.1 - 1.0 10years 0.1 - 0.8 0.1 - 0.8 16 + 0.04 - 0.4 0.04 - 0.4 Basophils x 109/l Any age 0.01 - 0.1 0.01 - 0.1

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 60 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Table 2: Coagulation tests Reference Ranges and Units of Measure : Normal Range Parameter Units Age Ratio (Seconds) Neonate – 12 INR Ratio 12.0 – 18.0 0.8 – 1.5 Months 1 Year – 16 years 12.0 - 16.0 0.8 - 1.4 16 + years 12 - 15.0 0.8 - 1.3

Neonate – 12 APTT Seconds 25.0 – 42.0 1.0 –1.5 Months 1 Year – 16 years 25.0 - 40.0 1.0 - 1.4 16 + years 25.0 - 38.0 0.8 - 1.3

Fibrinogen mg/dL Any age 180 - 400

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 61 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

TURNAROUND TIMES (*TAT only applies to routine working days)

TESTS: TARGET TIMES FBC (Urgent): 1 Hr FBC (Routine) - Wards: 4 Hr FBC (Routine) - OPD: 6 Hr FBC + ESR (Routine) - GP Hard copy: 24 hrs FBC + MP: 120 mins Blood Film: 1 working day INR (Anti-coag clinic): 60 mins Coagulation Screen (Routine): 3 hr D-Dimer for DVT/PE 3 Hr Glandular Fever Test: 3 working days Haemoglobinopathy Screen: 3 working days Haematinic assay: 3 working days Referral Tests: T-cell Subsets: 6 weeks Special Coagulation: 6 weeks Haemochromatosis: 6 weeks Others (EPO / DNA / tHcy): 6 weeks Cell Markers: 6 weeks Plasma Viscosity: 6 weeks ACL: 6 weeks Cytogenetics: 6 weeks Molecular gene sequencing: 3 - 6 Months

REFERRAL TESTS

Referral Tests are set at a suitable time for results to be available prior to patient’s next visit to the Haematology clinic. Delayed or urgent reports can be obtained from the referral laboratory by telephone. Haematology Referral Tests Repertoire

Test Referral Lab / Hospital Address Leukaemia Immunophenotyping Lab. Hampstead, London NW3 2PF. Immunophenotyping Royal Free Hospital T-cell Subsets SHIMDS Flow Cytometry The Halo Building,London,WC1H9AX immunophenotyping Level 2 Halo

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 62 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

HSL (Health Services Laboratories)

Cytogenetic studies SHIMDS Flow Cytometry The Halo Building,London,WC1H9AX Level 2 Halo HSL (Health Services Laboratories)

Haemochromatosis gene Blood Transfusion Reference Centre Colindale NW9 5BG mutation Erytrhopoietin Level Clinical Chemistry Dept. Denmark Hill, London SE5 9RS. Kings College Hospital Special Haemostasis Haemophilia Centre Hampstead, London NW3 2PF. investigations Royal Free Hospital Anti-cardiolipins Clinical Chemistry Dept. Hampstead, London NW3 2PF. Royal Free Hospital Homocysteine Level Clinical Chemistry Dept. Hampstead, London NW3 2PF. Royal Free Hospital Molecular studies for Molecular Lab. Hampstead, London NW3 2PF. Leukaemia Royal Free Hospital Molecular studies for Special Haematology Lab. Great Maze Pond, London SE1 9RT Haemoglobinopathies St Thomas’ Hospital. Plasma Viscosity Special Coagulation Lab. Whitney Street, London WC1 UCLH Blood Parasites Malaria reference Lab. Keppel St. London WC1E 1HT confirmation Hospital for Tropical Diseases. JAK2 status Leukaemia Science Laboratories Denmark Hill, London SE5 9RS Kings College Hospital G6PD Assay Special Lab Pond Street Royal Free Hospital London, NW3

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 63 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

BLOOD TRANSFUSION SPECIMEN REQUIREMENTS

Correct patient identification is of paramount importance in all aspects of Blood Transfusion. To ignore this fact could prove fatal to the patient being transfused. All specimens received, within the Blood Transfusion Laboratory, must meet the following criteria. 1. All specimens must be labelled with the full name, date of birth and hospital number (NHS number for requests from GP’s) and these must match the request form. 2. All specimens must be legible and not contain any amendments or crossings out. 3. The date and time the specimen was taken along with the signature of the phlebotomist is also required. 4. A clinical diagnosis or reason for the request must be on the request form. 5. For requests of blood components and products you MUST indicate any Special Transfusion Requirements (e.g. Irradiated, CMV negative etc.) on the request form. 6. Any specimen failing the above criteria will be rejected and the appropriate healthcare team informed as soon as possible especially if there are early requirements for blood components. 7. Any specimen that contains clots will be rejected and the appropriate healthcare team informed as soon as possible especially if there are early requirements for blood components. 8. All rejected specimens will be logged on to the LIMS and answered out with an appropriate comment. IMPROVING THE SAFETY OF BLOOD TRANSFUSION: ABO CONFIRMATORY TESTING

Wrong Blood In Tube (WBIT) incidents continue to occur at the Whittington owing to failures during phlebotomy of patients. To protect patients from a potentially fatal transfusion reaction the following protocol has been adopted for those patients where there is no historical blood group record (30%). 1. A sample on admission, or from a pre-clerking clinic, will be followed by a laboratory request for a confirmatory sample, but only from those patients that have no previous blood group record. In these cases the following will be added to the blood transfusion laboratory report:

“ABO confirmatory sample required ASAP or upon hospital admission” 2. Telephoned requests will be vetted against the laboratory record and a second independent sample will only be requested for those cases requiring ABO verification. 3. Cross-matched blood units will not be released, except in emergencies, until ABO verification against a second independent blood transfusion sample has been performed. A confirmatory ABO group should only take 10 minutes to perform after receipt of the second sample. 4. Two samples taken at the same time do not constitute a second confirmatory sample. This will not protect the patient if identified wrongly during phlebotomy. 5. Infants on the Neonatal Intensive Care Unit are exempted from this procedure because they receive group O Rh(D) Negative red cell transfusions.

Please see the following table for specimen containers and volumes required:

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 64 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

TEST REPERTOIRE

TEST SAMPLE TYPE SAMPLE SPECIAL PRECAUTIONS TIME LIMITS FOR REFERENCE UNITS VOLUME INTERFERING FACTORS ADDITIONAL RANGE TESTS Etc ABO/Rh blood group and Under-filled samples. 24 hours n/a n/a antibody screen Haemolysed samples. Adult & Infant (>6 months) EDTA pink top 6ml Clots in sample. Newborn (Cord) EDTA pink top 6ml Neonate (<6 months) EDTA red top 1ml NB 1 neonatal sample at birth will suffice for the first 4 months of life providing antibody screen and DAT negative. Direct Anti-globulin Test Under-filled samples. n/a n/a n/a (DAT) Haemolysed samples Adult & Infant (>6 months) EDTA pink top 6ml Clots in sample. Newborn (Cord) EDTA pink top 6ml Neonate (<6 months) EDTA red top 1ml Kleihauer test EDTA purple top 4ml Under-filled samples. n/a n/a n/a Haemolysed samples. Clots in sample. .

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 65 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

TEST SAMPLE TYPE SAMPLE SPECIAL PRECAUTIONS TIME LIMITS FOR REFERENCE UNITS VOLUME INTERFERING FACTORS ADDITIONAL RANGE TESTS Etc Cross-match red cells Under-filled samples. 72 hours if patient n/a n/a Haemolysed samples. transfused within the last 3 months Clots in sample.

7 days if patient not In an emergency, where no transfused in the last Adult & Infant (>6 months) EDTA pink top 6ml sample exists or has been 3 months tested, 2 units of uncross- matched O Rh D negative Neonate (<6 months) EDTA red top 0.75ml blood can be collected from the hospital blood transfusion

laboratory. NB 1 neonatal sample at birth will suffice for the first 4 months of life providing antibody screen and DAT negative Red Cell To be advised by To be advised Under-filled samples. Discuss with hospital n/a n/a Immunohaematology the hospital by the hospital Haemolysed samples. transfusion transfusion transfusion laboratory NHSBT Reference Centre Clots in sample Colindale NW9 5BG laboratory laboratory Histocompatibility & To be advised by To be advised Must discuss request with Discuss with hospital n/a n/a Immunogenetics the hospital by the hospital Consultant Haematologist transfusion NHSBT Reference Centre transfusion transfusion Under-filled samples. laboratory laboratory laboratory Colindale NW9 5BG Haemolysed samples. Clots in sample.

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 66 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

TEST SAMPLE TYPE SAMPLE SPECIAL PRECAUTIONS TIME LIMITS FOR REFERENCE UNITS VOLUME INTERFERING FACTORS ADDITIONAL RANGE TESTS Etc Haematopoetic Stem cell To be advised by To be advised Must discuss request with Discuss with hospital n/a n/a transplantation (patients the hospital by the hospital Consultant Haematologist transfusion and donors) transfusion transfusion Under-filled samples. laboratory laboratory laboratory NHSBT Reference Centre Haemolysed samples. Colindale NW9 5BG Clots in sample Platelet Immunology To be advised by To be advised Must discuss request with Discuss with hospital n/a n/a NHSBT Reference Centre the hospital by the hospital Consultant Haematologist transfusion Bristol BS34 7QH transfusion transfusion Under-filled samples. laboratory laboratory laboratory Haemolysed samples. Clots in sample Granulocyte Immunology To be advised by To be advised Must discuss request with Discuss with hospital n/a n/a NHSBT Reference Centre the hospital by the hospital Consultant Haematologist transfusion Bristol BS34 7QH transfusion transfusion Under-filled samples. laboratory laboratory laboratory Haemolysed samples. Clots in sample

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 67 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

TURNAROUND TIMES

REQUEST TARGET TIMES Emergency O Rh D negative red cells 0 minutes 2 units only – collect immediately from laboratory issues blood bank 2 units only – collect immediately from Labour ward satellite blood bank (obstetrics only) Emergency group specific uncross-matched red cells 15 minutes Emergency cross-matched red cells without antibody screen 45 minutes Urgent cross-matched red cells with antibody screen (full testing) 60 minutes

Kleihauer Test 72 hours

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 68 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

REFERRAL TESTS

All referrals go to the NHS Blood & Transplant laboratories. Referral Tests include: Red cell immuno-haematology Histocompatibility and Immunogenetics Leucocyte Immunology Platelet Immunology Granulocyte Immunology

Reports on these tests are slower since time must be allowed for transport of the sample. Details of reference laboratories are given on the hard copy reports. These are forwarded to the consultant responsible for the patient.

BLOOD TRANSFUSION REFERRAL TESTS REPERTOIRE Test Referral Lab / Hospital Address Red Cell NHSBT Reference Centre Colindale NW9 5BG Immunohaematology

*Histocompatibility & NHSBT Reference Centre Colindale NW9 5BG Immunogenetics

*Haematopoetic Stem cell NHSBT Reference Centre Colindale NW9 5BG transplantation (patients and donors)

*Platelet Immunology NHSBT Reference Centre Bristol BS34 7QH

*Granulocyte Immunology NHSBT Reference Centre Bristol BS34 7QH

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 69 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

MICROBIOLOGY

INTRODUCTION

The Department of Microbiology is committed to providing a diagnostic service to the Whittington Health and to doctors in general practice who use this laboratory. We aim to provide timely and accurate results for the samples sent to the laboratory for appropriate investigations. Advice is available on:  The management of microbial disease  Diagnostic tests  Anti-microbial chemotherapy  Anti-microbial assays  Control of infection  Immunology

LABORATORY HOURS

Monday to Friday (normal service) : 09.00 – 17.00 hrs Saturday (limited service) : 09.00 – 12.30 hrs AVAILABILITY OF CLINICAL ADVICE

Clinical advice for Microbiology is available at all times. During core hours (see above) phone: 020 7288 5085 or bleep: 3069. Out of hours contact can be made through the hospital switchboard on: 020 7272 3070. Clinical advice for Immunology is available during core hours only on: Mobile: 07745 946 772 Clinical advice for Andrology is available during core hours only on: 020 7288 3314

ON-CALL SERVICE

This is available for urgent requests only by phoning 07920 211488. It is covered by a single member of staff and requests should be restricted to those tests affecting immediate patient management. The following hours are covered by the out-of-hours service: Weekdays : 1700 - 0900 the following morning. Weekends : 1230 on Saturday – 0900 on Monday. Bank Holidays : 1230 – 0900 Good Friday & Christmas Day : 0900 – 0900

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 70 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

The following tests may be considered urgent provided that the result affects immediate patient management:  CSF microscopy and culture.  Ascitic fluid white cell count and culture.  Joint fluid gram and culture.  Any sample for osteomyelitis.  Urgent RSVs. (Only available week days and weekends 0900 – 1700 hours)  Urines only with the following indications: a) Pyelonephritis in pregnancy. b) Paediatric samples.

Other tests may be available on discussion with the on-call Biomedical Scientist but will be referred to the Microbiology Registrar on call for ratification. The on-call Biomedical Scientist should be notified about the sample. The sample should be hand delivered to the laboratory as soon as possible.

TELEPHONE NUMBERS

Consultant Microbiologist (Dr M.C. Kelsey) : 020 7288 5082 Dr. J. Andrews : 020 7288 3894 Dr. Magdalena Dziadzio – Consultant Immunologist: Mobile: 07745 946 772 Dr Gidon Lieberman - Lead Consultant for: Clinical: 020 7288 3314 Andrology Registrars : 020 7288 5085 (bleep 3069) Service Managers 020 7288 5086 Bacteriology (David Whittington) : Serology/Immunology (Christopher Buckingham): Molecular Diagnostics(Neil Jones): Infection Control Matron : 020 7288 3661 Infection Control Office : 020 7288 3261/3679 Enquiries/results – Bacteriology : 020 7288 5088 Enquiries/results – Serology : 020 7288 5087 Enquiries/results – Immunology : 020 7288 5087 Urgent requests out of hours : 07920 211488

General enquiries should be made on the Enquiries/results number listed above. The majority of questions can be handled by the office staff. For clinical advice, result interpretation and queries about the selection of investigations - one of our medical staff is available to discuss the subject matter. They can also be contacted by e-mail at: [email protected] USE OF THE LABORATORY Requesting

. Requests should be made using the ward-ordering module on Sunquest Ice.

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 71 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

. Clinical details are essential for an appropriate and targeted microbiological or serological investigation to be performed. It is recommended that request forms should include all relevant clinical findings as well as a working diagnosis. . Label each specimen with patient's name, hospital or NHS number, date of birth, type of sample and date and time of collection. . The printed request form from Sunquest Ice must accompany the sample. Place the specimen in the transparent transport bag and seal it. Put the form in the pocket between the plastic bag and the backing paper. The printed side must face outwards and be readable without removing the form from the bag. Do not put the form in the same compartment as the specimen. . Leaking or inadequately identified specimens will not be processed – although a report will be issued explaining why analysis was not performed. . Do not send patients to the laboratory for Microbiology samples to be taken without a prior appointment, we cannot guarantee that a member of the medical staff will be available.

N.B: The telephone symbol () denotes an appointment is necessary, please contact the department

Requesting Additional Tests

Additional tests maybe ordered on previous samples, dependent on the type of sample and its “shelf- life” in the laboratory. As a rule, Bacteriology samples such as urine, faeces, swabs, sputum and naso-pharyngeal aspirate are unsuitable for add-on tests after 1-2 days or are rendered unsuitable by the primary testing process.

The following samples are kept as follows: Sample Time Limit for Additional Tests

Serum from antenatal screening blood samples, 2 years save serum and long term saves

All other blood samples At least 2 weeks

CSF 3 months

Tissue 2 months Sterile fluids (e.g. Synovial fluid, Pleural fluid, 2 weeks Ascitic fluid)

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 72 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Specimen Containers Specimen containers used for Microbiological Investigation 20 ml sterile universal container Sterile stool universal container with spoon

250 ml sterile universal container 60 ml sterile universal container

Transport Swabs used for Microbiology/ Virology investigation

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 73 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

e-swab (Viral transport media) Bacterial swab Bordetella swab Chlamydia/GC swab

TURNAROUND TIMES

Turnaround times are given in each of the sub-sections below for the various specimens/investigations. They will be accurate for most requests but some isolates require more detailed investigation and may take longer. In these cases a preliminary report will be issued if significant organisms have been isolated. Samples sent to a reference laboratory usually take a minimum of 14 days and sometimes much longer. Note that the turnaround time is from the date of receipt of the sample and that the times refer to working days. Some, but not all, work is performed on weekend days. This department aims to issue at least 90% of reports within the specified time.

BACTERIOLOGY GENERAL REPORTING GUIDELINES

The policy of the laboratory is to report isolates reflecting the general nature of the flora at the sample site. Each site has a predominant regional flora and general comments such as ‘normal respiratory’ or ‘no significant growth’ may be made. Because it is not always possible to interpret the reports from the clinical data given, we will usually report antibiotic sensitivities from isolates we suspect to be significant. However, it is always necessary to take into account the clinical condition of the patient. The sensitivities reported are those that will generally be applicable to both hospital and primary care.

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 74 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

In the likelihood an isolate is resistant to several first line antibiotics, a second line group of antibiotics will be tested. Additional antibiotic sensitivity data is sometimes with-held, however enquiries can be made to the medical or laboratory staff should additional results be required.

1. Urinary Tract Investigation

Urinary tract infection results from the presence and multiplication of bacteria in one or more structures of the urinary tract with associated tissue invasion. The diagnosis of a urinary tract infection is based on the concept of significant bacteriuria. Laboratory investigation of UTI involves microscopy and quantitative culture. Microscopy is performed to establish the presence of WBC, RBC, cast, epithelial cells, crystals, organism and other cellular components present in a urine sample. Samples that are unrefrigerated for 6 hours will give a false positive culture results due to the multiplication of bacteria in vitro. Where there is any delay, specimens should be refrigerated at 4C. 1.1 MSUs (Midstream)/ ANCs (Antenatal)/ CCU(Clean catch urine) Urine microscopy is performed on all MSUs and SPAs excluding: ANC samples and samples from high risk patients e.g. Samples from HIV and TB patients – for health and safety reasons.

Significant isolates are considered to be a single colony type present in greater than 105 cfu (colony forming unit) per ml. The isolates are identified and antibiotic sensitivites performed. It is reported as >105/ml with the ID of the organism and its sensitivities. Pure growth of an organism that has a colony count of 104-105 cfu/ml is reported, but antibiotic sensitivities are not routinely released because the significance is equivocal. Mixed growths greater than 105cfu per ml are reported as “Mixed growth of 2 or 3 types of organism”. Mixed growths of less than 105 cfu per ml are reported as “No significant growth”. Cultures below our lower level of sensitivity (104 cfu per ml) are also reported as “No significant growth” For samples with clinical details indicating pregnancy or samples from the Antenatal clinic: particular attention is given to the presence of Group B streptococci, due to the significance to the unborn child - whether causing an infection or simply colonising the mother, and would always be reported.

Specimen Collection Female Midstream  Clean urethral area with soap and water.  Labia should be held apart and specimen collected after the initial flow of urine has been voided (1-2 seconds).  Label the container with patient’s name, date of birth, hospital or nhs number, date and time of collection  Wash hands thoroughly  Transport to laboratory promptly Male Midstream  Clean urethral area with soap and water.  Collect midstream urine with foreskin retracted  Label the container with patients name, date of birth, hospital or NHS number, date and time of collection  Wash hands thoroughly  Transport to laboratory promptly

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 75 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Bag urine for infants  Clean genital area thoroughly with soap and water and dry with sterile towel or let air dry.  Attach collection bag, do not replace nappy, once infant has voided transfer urine into collection container immediately. Dispose the collection bag in accordance with local ward protocol.  Label the container with patients name, date of birth, hospital or NHS number, date and time of collection  Wash hands thoroughly  Transport to laboratory promptly

Container/Minimum Volume Sterile universal container 1 – 25 ml

Turnaround time Microscopy - if performed on day of receipt 1-2 days for negative cultures 2-5 days for positives cultures

1.2 Catheter Urine (CSU) Samples should not be taken unless clinically indicated. Microscopy will not be performed as the presence of the catheter can induce an apparent pyuria that does not reflect the true condition of the patient.

Any growth from a CSU sample maybe significant however the mid-stream criterion of significant growth does not apply. If one or two types of organism are isolated, the isolates are identified and sensitivities are performed. The isolates are reported as “Growth of (organism)”. If three or more types of organism are present, it is reported as “Mixed growth of 3 types of organism”. As a routine no antibiotic sensitivities will be released though they remain within the system if it is required.

Specimen Collection Microbiology Clinical Guidelines – Insertion and Maintenance of indwelling catheter

Container/Minimum Volume Sterile universal container 1 – 25 ml

Turnaround time 1-2 days for negative cultures 2-5 days for positive cultures

1.3 Suprapubic aspirate (SPA) It is seen as the “gold standard” but is usually reserved for clarification of equivocal results from voided urine in infants and small children. Any growth from an SPA sample is regarded as significant. Isolates are identified and sensitivities are performed. Specimen collection  Performed by trained medical staff  Transfer into sterile universal container

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 76 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

 Label the container with patient’s name, date of birth, hospital or nhs number, date and time of collection  Wash hands thoroughly  Transport to laboratory promptly

Container/Minimum Volume Sterile universal container 1 – 25 ml

Turnaround time 1-2 days for negative cultures 2-5 days for positive cultures

1.4 Prostatic Massage Urine These samples are performed for the investigation of prostatitis. Two specific urine samples (VB1, VB2 – see below) are passed to establish a baseline for urinary tract infection following which prostatic massage is used to obtain a sample of expressed prostatic secretion (EPS). A further urine sample is then collected (VB3).

VB1 should be the initial 5-8 ml of voided urine. VB2 should be a mid-stream urine (MSU). VB3 should be the first 2-3 ml of voided urine following prostatic massage.

Microscopy is only performed on expressed prostatic secretion (EPS).ID and sensitivities are only performed if the same organism is isolated from EPS and VB3.

Specimen collection  Performed by trained medical staff  Transfer into sterile universal container  Label the container with Patient’s Name, Date of Birth, Hospital or NHS number, Date and Time of collection. The type of sample VB1,VB2,EPS &VB3  Wash hands thoroughly  Transport to laboratory promptly

Container/Minimum Volume Sterile universal container 1 – 25 ml

Turnaround time 1-2 days for negative cultures 2-5 days for positive cultures

1.5 Other Urine Samples for Investigation These specimens are obtained during or as a result of surgery and include ileal conduit, cystoscopy, nephrostomy and urostomy. These samples are treated as for CSU.

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 77 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

2. Gastrointestinal Disease Investigation

Investigations for faecal pathogens are highly reliant upon comprehensive clinical details (travel history, onset of symptoms and medication). Samples are only tested routinely for more common faecal pathogens (Campylobacter, Salmonella, Shigella and E.coli 0157). However, dependent upon clinical details, the sample may be investigated for additional pathogens such as Vibrio and Yersinia. If PCR/culture is negative, it is reported as such. If positive the organism is usually reported with the antibiotic sensitivities suppressed. In some instances isolates need referral to the reference laboratory for confirmation and typing. Reference laboratory reports normally take two-three weeks to come back. Clostridium difficile screening is performed using an Enzyme Immuno-Assay (EIA) method to detect the presence of the organism. Samples from in-patients with diarrhoeal infection as well as institutionalised patients (e.g. nursing home residents) or those recently discharged from hospital.GP and Outpatient ≥ 65 years old are screened. This toxin is labile and requires a refrigerated specimen no older than 48 hours. If the initial screening proves to be positive the sample will be tested for the presence Clostridium difficile toxin. Results from the screening are reported as Negative or Detected and the appropriate comment goes with the result. For further information please refer to Whittington Trust Intranet: Microbiology-Clinical Guidelines – Clostridium difficile infection, Guideline for treatment and management. Clostridium difficile culture is only performed in exceptional circumstances after discussion with microbiologist consultant/registrar. Investigation for Parasites requires appropriate clinical details that include: travel history, onset of symptoms consistent with enteric parasitic infection. A faeces sample should be sent in the same way as for culture. A negative sample does not exclude parasitic infection and further samples should be requested if clinically indicated. Parasites are detected using microscopic examination of concentrated faeces. It is examined for the presence of ova, cysts, and parasites. Not all investigation for parasites requires a stool sample for example, if investigating for Schistosoma species Terminal urine or a random midday sample should be sent to the laboratory. For Enterobius vermicularis (Thread worm) a sellotape impression slide preparation is the preferred sample. In cases of AIDS related diarrhoea - Cryptosporidia and other protozoan pathogens will be screened for. Helicobacter antigen testing of faeces provides a diagnostic tool that is non-invasive. Antigen detection is more diagnostically valuable than the serum antibody test. Results are release as Detected or Not Detected. Children under 5 years of age will be tested for Rotavirus. Rotavirus is a common cause of diarrhoea and gastroenteritis especially in children. It is present in the faeces 3-5 days after onset of symptoms with marked decline after 8-9 days. Rotavirus detection is performed using membrane bound antigen- capture method and reported as Negative or Detected. This test cannot be used for samples from babies less than 3 months old. Children under 5 years of age will be tested for Cryptosporidium infection. This is estimated to be responsible for 1% of cases of diarrhoea with a high proportion occurring in children. It is also a particular problem for HIV-infected patients and account for 3% of UK AIDS patients that suffer from cryptosporidiasis. Diagnosis is based on demonstrating oocyst in stools using auramine-phenol stain. It is reported as Oocysts of Cryptosporidium Not seen / Present. Norovirus is a contagious virus that causes acute diarrhoea and projectile vomiting. It is also known as winter vomiting bug. Samples are tested by PCR method after discussion with the Infection control team. Specimens should be collected as soon as possible after onset of symptoms. It should be passed into a clean, dry container uncontaminated by soap, detergent, or disinfectant. Specimen samples should be transported as soon as possible due to pH changes that adversely affect viability of some pathogens such as Shigella species. Refrigeration can help preserve the balance of faecal flora in samples. A separate sample for each investigation is required when requesting multiple analyses

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 78 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

2.1 Specimen collection for faecal PCR or culture

newspaper. Make sure the sample does not touch the inside of the toilet.  Using the spoon attached to the lid - place the sample in a sterile universal container and screw the lid shut  Label the container with the Patient’s Name, Date of Birth, Hospital or NSH number, Date and Time of collection.  Wash hands thoroughly  Transport to the laboratory promptly and if there is delay store the container in the fridge at 40C

Container/Minimum Volume Sterile universal container with spoon 1 – 25 ml (at least 1ml or a large pea sized piece – DO NOT fill container to brim)

Turnaround Time 1 – 2 working days for negative PCR or 2-4 working days for negative cultures If the PCR is positive a preliminary result will be issued and an indication will be given as to what additional tests are being conducted. If culture Positive a preliminary report will be issued within 3-6 days and it will be sent to the Reference Laboratory for Confirmation and Typing. A final report will be issued once the report from the Reference Laboratory has been received which takes about 2-3 weeks from the time it was sent.

2.2 Specimen collection for Clostridium difficile screening  Formed samples and cases that have tested positive within the past 28 days will not be processed.  Refer to Whittington Trust Intranet: Microbiology-Clinical Guidelines – Clostridium difficile infection, Guideline for treatment and management. Transport to the laboratory promptly and if there is delay store the container in the fridge at 40C as toxins are heat labile.

Container/Minimum Volume Sterile stool universal container 1 – 25 ml (at least 1ml or a large pea sized piece) – DO NOT fill container to brim

Turnaround Time 1-2 days

2.3 Specimen collection for Ova, Cyst & Parasite investigation  Ideally three stool specimens collected on three consecutive days (especially if Strongyloidiasis suspected)

newspaper. Make sure the sample does not touch the inside of the toilet.  Using the plastic spoon in the lid place the sample in a sterile universal container and screw the lid shut  Label the container with the Patient’s Name, Date of Birth, Hospital or NHS number, Date and Time of collection.  Wash hands thoroughly  Transport to the laboratory promptly and if there is delay store the container in the fridge at 40C

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 79 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Enterobius vermicularis

Materials for collection and transportation of these sample are generic and should be available to clinicians through their own supply chain – however should there be difficulty they can obtain advice and assistance by contacting the laboratory at the numbers provided..  Take the sample by impressing a 4-5 cm strip of the adhesive side of the transparent cellulose tape onto the peri-anal skin. Stick the adhesive side of the tape into the glass slide ensuring that the entire strip is flat. Place the slide in a slide carrier for transport to the laboratory.  Label the container with the Patient’s Name, Date of Birth, Hospital or NHS number, Date and Time of collection.  Wash hands thoroughly  Transport to the laboratory promptly

Schistosoma Haematobium

 Label the container with the Patient’s Name, Date of Birth, Hospital or NHS number, Date and Time of collection.  Wash hands thoroughly  Transport to the laboratory promptly

Amoebic dysentery (Entamoeba histolytica)  This investigation is only processed after discussing with the microbiologist registrar.  A “hot stool” is required for this investigation. The sample should be delivered to the laboratory within 30 minutes of production.  Label the container with the Patient’s Name, Date of Birth, Hospital or NHS number, Date and Time of collection.  Wash hands thoroughly  Phone the laboratory once the sample has been collected.  Transport to the laboratory promptly

Container/Minimum Volume Sterile stool universal container 1 – 25 ml (at least 1ml or a large pea sized piece – DO NOT fill container to brim)

Turnaround Time 3-5 days

2.4 Specimen collection for Helicobacter Antigen testing lean plastic container or a newspaper. Make sure the sample does not touch the inside of the toilet.  Using the plastic spoon in the lid place the sample in a sterile universal container and screw the lid shut  Label the container with the Patient’s Name, Date of Birth, Hospital or NHS number, Date and Time of collection.  Wash hands thoroughly  Transport to the laboratory promptly and if there is delay store the container in the fridge at 40C

Container/Minimum Volume

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 80 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Sterile universal container 1 – 25 ml (at least 1ml or a large pea sized piece – DO NOT fill container to brim)

Turnaround Time 3-5 days

Limitation of the procedure 1. Antimicrobials, proton pump inhibitors and bismuth preparations are known to suppress H. pylori and ingestion of these prior to testing may give a false negative result. If a negative result is obtained for patient ingesting these compounds within two weeks prior to testing, a new specimen should be submitted two weeks after discontinuing treatment. A positive result for a patient ingesting these compounds should be considered accurate. 2. Performance characteristics have not been established for watery and diarrhoeal stools nor in asymptomatic individuals. 3. H2 blockers do not interfere with positive results.

2.5 Specimen collection for Norovirus Investigation

 Not a routine investigation, sample will only be sent after discussion with Infection Control team.

Container/Minimum Volume Sterile universal container 1 – 25 ml (at least 1ml or a large pea sized piece – DO NOT fill container to brim)

Turnaround Time 1-2 days (unless sent to reference laboratory)

3. Sterile Body Fluid Investigation Cerebrospinal fluid investigation

Microorganisms cross the blood/brain barrier, either by haematogenous spread or from surface structures, such as the ears and nasal sinuses, and penetrate to the CSF, where they may multiply, and causing meningitis. The commonest organisms found are: Organism Population most frequently affected Streptococcus pneumoniae Children and the elderly Neisseria meningitidis Children and young adults Haemophilus influenzae Children from 2 months to 6 years old Escherichia coli Neonates Group B Streptococci Neonates

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 81 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Viruses and other organism such as TB can also be isolated from CSF samples. Investigations are performed after discussion with the microbiologist registrar. Samples are sent to the reference laboratory and tested by PCR method. If meningitis is suspected contact the laboratory immediately and deliver the specimen to the laboratory in person and without delay. The sample is normally taken as three aliquots of 2-3 mls or more in a universal sterile container(20ml). All the aliquots are forwarded to the laboratory. Generally the first and third (or last) sample aliquots are the most important for Microbiology. The second or middle samples are suitable for sending to other laboratories as required. Relevant clinical details are essential in guiding the Biomedical Scientist to take the appropriate precautions and further investigations necessary during processing of the sample. If Cytology testing is required a separate aliquot and form should also be sent to the Cytology Department. Cell count (white/red) and culture is performed on the third or last aliquot of sample as it will give the most representative count. Normal white cell count as follows: Neonate: <30 /mm3 1 to 4 years old: <20 /mm3 5 to 12 years old: <10 /mm3 >12 years old and above: <5 /mm3 If the white cell count is raised additional investigation is performed. These include gram stain and differential count. Additionally: India ink and Auramine (only with relevant clinical details and after discussion with microbiologist registrar). If a clotted sample is received the cell count is not performed only the gram stain.

For Subarachnoid Haemorrhage (SAH) investigation Microbiology needs the First and Third samples (the second sample should usually be sent to Biochemistry). The red cell count will be performed on both bottles. A similar red cell count on both bottles is indicative of subarachnoid haemorrhage rather than traumatic tap. On receipt of sample, the appearance, cell count and other investigation such as gram stain, differential count, Auramine, and India ink are reported on same day. Results are telephoned to the requesting clinician or microbiologist registrar. If culture is negative, it is reported as “No growth at 48 hours incubation” from the time it was received in the laboratory. Any growth from this sample maybe significant. The ID and sensitivities of the organism is reported. If the sample has been sent to the reference laboratory for further testing a preliminary report will be issued. Preliminary positive results will typically be available at 24 – 48 hours post receipt of sample (depending on the type of organism) with follow up results available after a further 24 hours.

Joint fluid investigation Septic arthritis is usually caused by Staphylococci aureus and Streptococci. Less common causes are gram negative bacilli, especially in young children, people with chronic illness or IVDUs. In children <2 it may be caused by Haemophilus influenzae, children with the condition often having a concomitant upper respiratory tract infection. Sexually active people may acquire infection from Neisseria gonorrhoeae. Anaerobic infections may occur in prosthetic joints. The laboratory acknowledges the difficulty involved in obtaining this kind of sample. A minimum volume of 1ml in a sterile universal container (20ml) is adequate for the investigation, however should further investigation be required a low volume may prevent us from undertaking a full diagnostic analysis. A sample volume >20ml will aid us in maximizing the recovery of the causative organism if present. Relevant clinical details are essential in guiding the Biomedical Scientist to take the appropriate precautions and further investigations necessary during processing of the sample. If Crystal investigation is required, a separate sample and form should be sent to Cytology department.

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 82 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

On receipt of sample a gram stain is performed and the result is available on same day. The Gram stain result is telephoned to the requesting clinician if the laboratory has been notified of its urgency. If culture is negative, it is reported as “No growth at 48 hours incubation” from the time it was received in the laboratory. Any growth from this sample maybe significant. The ID and sensitivities of the organism is reported. If further investigation is required a preliminary report is issued. Preliminary positive results will typically be available at 24 – 48 hours post receipt of sample (depending on the type of organism) with follow up results available after a further 24 hours.

Ascitic fluid investigation Primary bacterial peritonitis accounts for <1% of bacterial peritonitis and occurs spontaneously without evidence of intra-abdominal organ perforation. It is most frequently seen in normal infants and children, children with nephrotic syndrome, and patients of all ages with cirrhosis. The laboratory acknowledge sthe difficulty involved in obtaining this kind of sample. A minimum volume of 1ml in a sterile universal container (20ml) is adequate for the investigation, however should further investigation be required a low volume may prevent us from undertaking a full diagnostic analysis. A sample volume >20ml will aid us in maximizing the recovery of the causative organism if present. Relevant clinical details are essential in guiding the Biomedical Scientist to take the appropriate precautions and further investigations necessary during processing of the sample. If Cytology or Biochemistry investigation is required, a separate sample and form should be sent to the respective department. On receipt of sample a neutrophil count is performed. A negative count is <250. A differential count and gram stain will be performed if the count is raised. The result is available on the same day. Results are telephoned to the requesting clinician if the laboratory has been notified of its urgency. If culture is Negative, it is reported as “No growth at 48 hours incubation” from the time it was received in the laboratory. Any growth from this sample maybe significant. The ID and sensitivities of the organism is reported. If further investigation is required a preliminary report is issued. Preliminary positive results will typically be available at 24 – 48 hours post receipt of sample (depending on the type of organism) with follow up results available after a further 24 hours.

Pleural fluid investigation Accumulation of fluid between the inner and outer (visceral and parietal) layers of the pleura is known as pleural effusion. It may arise as the result of pneumonia or of chronic heart failure or uraemia (when cultures will be negative), or by direct spread of infection, such as a primary tuberculous focus rupturing into the pleural cavity. Carcinomatous involvement of the visceral pleura is one of the more common causes of sterile pleural effusions. The laboratory acknowledge s the difficulty involved in obtaining this kind of sample. A minimum volume of 1ml in a sterile universal container (20ml) is adequate for the investigation, however should further investigation be required a low volume may prevent us from undertaking a full diagnostic analysis. A sample volume >20ml will aid us in maximizing the recovery of the causative organism if present. Relevant clinical details are essential in guiding the Biomedical Scientist to take the appropriate precautions and further investigations necessary during processing of the sample. If Cytology or Biochemistry investigation is required, a separate sample and form should be sent to the respective department. On receipt of sample a gram stain is performed and the result is available on same day. The Gram stain result is telephoned to the requesting clinician if the laboratory has been notified of its urgency. Auramine microscopy results are usually available a day after. If culture is negative, it is reported as “No growth at 48 hours incubation” from the time it was received in the laboratory. Any growth from this sample maybe significant. The ID and sensitivities of the organism is reported. If further investigation is required a preliminary report is issued. Preliminary positive results will typically be available at 24 – 48 hours post receipt of sample (depending on the type of organism) with follow up results available after a further 24 hours.

For Mycobacterium investigation please refer to Investigation of Tuberculosis.

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 83 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

4 Superficial/Non-Superficial Body Sites/Tissues/Abscess/Other Body fluids/Tips Investigation Investigation for these samples, are reliant on the clinical information provided such as body site, signs and symptoms and underlying conditions. Due to the nature of the specimen not all isolated organisms are significant. The isolation of a particular organism is often typically associated with a specific clinical condition or a particular body site. Transport swabs contain a medium to preserve organisms and prevent overgrowth. They should be refrigerated at 4C if there is to be a delay in transporting them to the laboratory. Tissue samples/Abscess/Body fluids/IUCD should be sent to the laboratory, as soon as possible, in a sterile universal container without formalin Gram stain is usually performed on samples such as tissues, pus, certain body fluids, intra-uterine contraceptive device, eye swabs from infants less than 1 month old, urethral swabs (with relevant clinical details). The result is available on the same day and telephoned to the requesting clinician if the laboratory has been notified of its urgency. The culture is negative if no pathogens are isolated within 48 hours of receipt and processing. It may be reported as “No growth at 48 hours of incubation”. A “Mixed growth of doubtful significance” is reported if there are 2 or more organism present but not clinically significant. “No significant growth” is reported if the organism isolated is part of a normal flora. These negative results should be reported 2-3 working days after the sample is taken. If a significant pathogen is isolated, the organism is identified and antibiotic sensitivities reported. Significant pathogens isolated will be telephoned if they are likely to have an immediate effect on the patient outcome. If further investigation is required a preliminary report is released. Positive final results should be reported 3-4 working days after the sample is taken – unless an isolate is problematic or requires further investigation by a reference laboratory.

Container/ Specimen How to collect minimum vol. Abscess

Open Aspirate if possible or pass swab deep into lesion and Sterile universal firmly sample lesion’s edge. container Closed Aspirate abscess material with needle and syringe. or Aseptically transfer all material into sterile universal Swab placed in container. transport medium. Animal bite See abscess - if an animal bite is to become infected it will generally have signs of infection within 24 hours. Cultures taken before 12 hours do not usually yield a pathogen. Cellulitis Aspiration specimens from cellulitic areas only yield 25- 35% growth on culture. Organisms grown can only be regarded as possible pathogens. Ear

Middle Tympanocentesis is indicated for complicated, recurrent, Sterile universal or chronic persistent otitis media. container External 1. Use moistened swab to remove any debris or crust Or swab placed form ear canal. in transport medium. 2. Firmly rotate a fresh moistened swab in outer canal to obtain sample. Fungal cultures are performed routinely on external

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 84 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

ear samples

Eye

Conjunctiva Sample both eyes with separate swabs (pre-moistened Swab placed in with sterile saline) by rolling swab over each conjunctiva. transport Sample both conjunctivae to determine indigenous medium. microflora. Uninfected conjunctiva may serve as a control. Throat The sample should be collected by a trained clinician - Swab placed in firmly rotating a moistened swab against the back of the transport throat. medium.

5 Throat swabs Negative results should be reported 2-3 working days after the sample is taken. Only -haemolytic streptococci belonging to Lancefield Group A, C or G and Corynebacterium diphtheriae will be routinely reported. Significant β-haemolytic streptococci will be reported with sensitivities. If Corynebacterium diptheriae is isolated, it is sent to the reference laboratory for confirmation and typing. This is a notifiable organism. Positive final results should be reported 3-4 working days after the sample is taken – unless an isolate is problematic or requires further investigation by a reference laboratory.

Bordetella pertussis Investigation+

Bordetella pertussis is a highly contagious bacteria and causes whooping cough. It is spread by droplet infection. A pernasal swab is the correct choice of specimen. Cough plates do not give such good isolation rates. Throat swabs are not suitable because Bordetella sp. have a particular trophism for ciliated respiratory epithelium, which are not found in the nose or pharynx. Pernasal swabs should be brought to the laboratory within an hour from the time of collection any delay will invalidate the sample. Specimen collection during working hours is performed by the Microbiologist registrar. The registrar can be reach by contacting ext. 5085 or bleep 3069. If the medical staff has undergone sufficient training, they could perform the collection but are required to contact the laboratory to obtain the pernasal swab and Bordetella plate. A negative culture is reported after 7 days of incubation upon receipt in the laboratory. If Bordetella pertussis or Bordetella parapertussis is isolated it is reported as such. Bordetella PCR testing of the swab is only performed after discussion with the microbiologist registrar. This investigation is a send away test.

6 MRSA SCREENING INVESTIGATION MRSA strains are a continuing and increasing problem in many hospitals. Colonized and infected patients represent the most important reservoir of MRSA strains in hospitals. MRSA are mainly transmitted by direct person-to-person contact, usually via the hands of health care workers. Screening for MRSA provides a means of identifying patients and staff who may be involved in transmission of the organism. Patients admitted in A&E and other admitting wards are screened for MRSA colonization within 6 hours of admission. This investigation is also included in the Neonatal Admission Screen. Rapid PCR detection of MRSA is performed if the patient is to be sent for augmented care and/or emergency surgery in the next 48 hours. Clinicians will need to order the request on Anglia ICE and answer the questions when prompted.

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 85 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Sample of choice for this investigation are nose, groin, wound or indwelling devices. Use a separate swab for each area. Moisten the swab using the transport medium, sterile water or saline, swab the area. After sampling place the swab directly into the sterile transport medium. Label the swab and send to the laboratory promptly.

Negative cultures will usually be reported a day after receipt in the laboratory. Positive cultures will take 2-3 days longer. The ID and sensitivities will be reported. Clinician will be informed by telephone results once confirmed by the laboratory.

Requests meeting the criteria for PCR testing will have a turnaround time of 4-24 hours upon receipt in the laboratory. Negative PCR will be reported as Negative. Samples that are Positive for PCR will be reported as “Positive complimentary culture to follow” if the organism is successfully isolated the sensitivities will be reported. If the laboratory fails to isolate the organism a report “ Positive PCR report stands” will be issued. For further information please refer to the Whittington Trust Intranet- Clinical Guidelines – Microbiology – MRSA Screening Policy

Limitation of the procedure for MRSA PCR 1. Screening determines the colonisation status at a given time. Colonisation may vary depending upon patient treatment, patient status or exposure to high-risk environments. 2. A Positive result does not necessarily indicate eradication treatment failure since DNA presence may persist. A Negative result following a previously positive test result may indicate eradication treatment success or intermittent colonisation. 3. A Positive test result does not necessarily indicate the presence of a viable organisms. A positive result is indicative of the presence of MRSA DNA. 4. Tobramycin at high concentration may cause slight inhibition in the Assay. 5. False negative results may occur due to loss of nucleic acid from inadequate collection, transport or storage of specimens.

7 Miscellaneous investigation Endoscopy water Testing Endoscopes used in diagnostic procedures require safe and effective methods of decontamination between patients. The laboratory monitors the rinse water after use to ensure that the bacterial load is within acceptable limits. The trust has three endoscope washers. The laboratory receives a sample of the rinse water on a weekly basis. Samples are from rinse water taken after a complete rinse cycle. A sample of rinse water is put in a sampling bottle that has 10mg sodium thiosulphate. The sampling bottle can be ordered in EPROC, if product code is required phone the department ext.4829/5084. An interim 48 hour result of the colony count is released from the time the rinse water is received from the laboratory. A further report for the presence/absence of Acid Fast Bacilli will be issued after 5 days from the time the rinse water is received from the laboratory.

Colony Count – Interpretation/Action <1 - Satisfactory 1-9 - Acceptable, under reasonable level of control

10-100 - Unsatisfactory, investigate and disinfect as per protocol

>100 - Unacceptable, take out of service until water quality has improved

*** This testing process does not fall within the scope of CPA or UKAS accreditation ***

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 86 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Urinary Pregnancy Testing This investigation detects the presence of HCG (Human Chorionic Gonadotropin). HCG is a glycoprotein hormone produced by the blastocyst and normally begins to be detected in the urine from 7 days after conception. The test kit can detect ≥25mIU/mL concentration in a urine sample. Results are reported as Positive or Negative on the day of receipt in the laboratory. Sample Collection The recommended sample is a first morning urine sample but a urine sample collected any time of the day is also suitable. Urine sample must be collected in a clean, dry 20 ml sterile universal container. A minimum volume of 1 ml must be submitted to the laboratory for testing.

Limitations of Test 1. Positive results from very early pregnancy may later prove negative as natural termination is estimated to occur in 31% of all conceptions. It is therefore recommended that weak positive results are re-tested 48-72 hours later with a first morning urine sample.

2. A negative result may be obtained if a urine sample is too dilute. If pregnancy is still suspected, it is recommended the patient should be retested 48-72 hours later with a first morning urine sample.

3. Concentrations of HCG are generally lower in ectopic pregnancy than expected normal values for a given gestational age. Abnormal pregnancy cannot be distinguished from normal pregnancy by HCG levels alone

4. HCG remains elevated for a time after pregnancy. Pregnancy test carried out less than 3 weeks after giving birth or 9 weeks after natural loss or termination may need further evaluation.

5. A number of conditions other than pregnancy can cause elevated levels of urinary HCG e.g. menopause, trophoblastic disease and certain non-trophoblastic neoplasms.

6. Occasionally samples containing <25mIU/mL HCG may test positive but samples containing <5mIU/mL should be negative.

7. Drugs containing HCG may interfere and produce misleading results.

8. False positive and false negative results may be observed in patients with abnormal bladder or kidney function e.g. enterocystoplasties and renal failure. 9. Inconsistent results may be obtained if the urine sample contains excessive amounts of bacteria. 8 Blood Culture Investigation Blood cultures should be taken from any patient who is systemically ill wherein an infective diagnosis is being considered. It should be taken before commencement of antibiotic treatment. It is essential that all relevant clinical details including foreign travel, underlying disease, signs, and symptoms should be written on the request form. Yields are higher during episodes of pyrexia. Blood culture bottles are not normally available at GPs’ surgeries as they are used only infrequently and have a short shelf life. Contact the medical staff in Microbiology ext 5085 before sending the patient at the Whittington for a venepuncture. Negative cultures are released after the maximum incubation period. A 48 hr interim report is issued on all paediatric bottles. If a culture has a significant isolate the result will be telephoned by the medical staff to the requesting clinician and an interim report is issued. The final report will only be issued after all investigations on the culture vials are completed. Please refer to Whittington NHS Trust Intranet: Clinical Guidelines: Blood Culture Collection Policy The following blood culture vials are available for routine testing in the department:

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 87 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Aerobic/F (grey cap) & Anaerobic/F (yellow cap) Culture Vials A set of two bottles collected for adult bacterial infection. It has 5 days incubation from the time of receipt in the laboratory.

Paeds/F (pink cap) Culture Vials A single bottle collected for children bacterial infection. It has 5 days incubation period from the time of receipt in the laboratory.

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 88 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Mycosis-IC/F (green cap) Culture Vials A single bottle collected for the recovery of fungi and yeast in all patients suspected of fungaemia. It is available in the laboratory on request. It has 14 days incubation period from the time of receipt in the laboratory.

Myco/F (white cap) Lytic Culture Vials A single bottle collected for the recovery of mycobacteria from blood specimens in patients having mycobacterial infection. It is available in the laboratory on request. It has 6 weeks of incubation period from the time of receipt in the laboratory.

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 89 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Warning and Precautions Prior to use, each vial should be examined for evidence of contamination such as cloudiness, bulging or depressed septum or leakage. DO NOT USE any vial showing evidence of contamination. A contaminated vial may contain positive pressure. If a contaminated vial is used for direct draw, gas or contaminated culture media could be refluxed into the patient’s vein. Vial contamination may not be readily apparent. If a direct draw procedure is used, monitor the process closely to avoid refluxing the materials into the patient. Prior to use the user should examine the vial for evidence of damage or deterioration. Vials displaying turbidity, contamination, or discolouration (darkening) should not be used. On rare occasions, the glass bottleneck may be cracked and the neck may break during removal of the flip-off cap or in handling, or the vial may not be sealed sufficiently. In these cases, the contents of the vials may leak or spill especially if the vial is inverted. If the vial has been inoculated, treat the spill or leak according to the local ward protocol. Storage Instructions The Culture vials are ready to use as received. Store in a cool, dry place (2-250C), Out of direct light.

Specimen collection The specimen must be collected using sterile techniques to reduce the chance of contamination. The recommended specimen volume is 5-10 ml per bottle for adults and 1-2 ml per bottle for paediatric patients. The rationale behind using a paediatric vial is to mitigate the low volume available from small children and babies. Where an adequate volume can be obtained from an older child the use of the adult set is preferable. Remove the flip-off cap from the vial top and inspect the vial for cracks, contamination, and excessive cloudiness, bulging or indented septa. DO NOT USE if any defect is noted. Disinfect the rubber with 70% alcohol wipe and let it dry for 1 minute. Disinfect the venepuncture site with 70% alcohol wipes concentrically for at least 30 seconds. Do not palpate the vein at this point. Draw the blood and inoculate the culture vial. Dispose the used sharps according to local ward disposal procedure. Label the blood culture bottle. Transport the inoculated culture vial as quickly as possible to the laboratory.

9 Respiratory Sample Investigation Sputum for culture and sensitivity

The potential for contamination with upper respiratory tract flora is considerable and semi-quantitative cultures applied to assist interpretation. Moderate to Heavy growths of the major pathogens: Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis are reported. Routine culture negative is reported as “No growth at 48 hours of incubation”. Positive cultures are reported after 2-4 days with ID of the organism and sensitivity. “A mixed growth of doubtful significance” is reported when a mix of extraneous non-pathogens are isolated. ‘Normal respiratory flora’ is reported when there is growth of normal respiratory tract flora. Severe pneumonias should have blood cultures sent to the laboratory.

Isolation of coliforms and pseudomonads in patients with chronic obstructive airways disease usually reflect prior antibiotic therapy and are not often pathogens. In most cases, Staphylococcus aureus isolation will usually reflect throat carriage. In cystic fibrosis patients, Pseudomonads and Staphylococcus aureus are also considered as potential pathogens.

For this investigation send an expectorated sputum. Ideally this sample should be collected under the supervision of nurse or physiotherapist to ensure a good quality sample. Collect the sample in a sterile wide necked 60 ml container. At least 2ml of sample is needed. A single sample may reveal significant pathogens. More than one sample (of standard sputum) from the same patient taken on the same day is likely to be regarded as duplication and not processed. If three samples taken on consecutive days are negative, and you still suspect infection, then you are advised to discuss the case with the Microbiology doctors.

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 90 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Investigations for tuberculosis The first specimen of sputum expectorated in the morning is usually the most suitable. The initial result of the investigation will be a phenol auramine stain, which will be reported and telephoned by the medical staff if AFB is present before culture is available. The ideal investigation would include three early morning sputum samples taken on consecutive days.

On all isolates of Mycobacterium tuberculosis antibiotic sensitivities will be performed on the first isolate and all other subsequent isolates which follow more than three months after the initial isolate. Where sputum is not available, three early morning gastric washings maybe investigated. The whole of an early morning urine sample collected in a 250ml sterile container may be useful in disseminated disease. For non-pulmonary disease, the results of tissue biopsy e.g. liver or lymph node may be the most appropriate investigation.

Turnaround times are the same irrespective of the type of specimen. Samples are inoculated in a liquid broth medium that is known to yield better recovery and faster growth of mycobacteria. The medium is incubated in an automated continuous monitoring system. Positive cultures are immediately flagged and investigated. A preliminary report is issued if an Acid Fast Bacilli is seen from the culture. The ward or GP will be notified through telephone by the medical staff. The isolate is then sent to the reference laboratory for confirmation and sensitivity testing. Samples are incubated for 6 weeks, after which those still negative are reported as such. The turnaround time for these is approximately 49 days from receipt of the specimen. If a culture becomes contaminated during its incubation period it is reprocessed and the stage of incubation are reset to zero.

A sample for fast-track TB investigation is available in the laboratory upon discussion with the medical staff. Results are available on the day of receipt. It detects the presence or absence of MTB (Mycobacterium tuberculosis) and the resistance on Rifampicin. This test has only been validated for sputum samples. A minimum sample volume of 1 ml is required for this test alone. Samples of less than 1 ml will be rejected. In order to perform TB culture in addition to this - a sample volume of >3 ml is required.

Investigation of atypical pneumonia In most instances the investigation of atypical pneumonias will involve only examination for Mycoplasma pneumoniae and Legionella pneumophila. Other possible aetiologies e.g. Chlamydia pneumoniae, Chlamydia psittaci and Coxiella burnetii (Q fever) will only be pursued after discussion with the medical staff. For this investigation a clotted blood sample (2-10 ml) should be taken during the acute and convalescent stage. This is a test referred to the reference laboratory.

If infection with Legionella pneumophila is suspected, it is important that sputum for culture is sent as this is often the most rapid way of confirming the diagnosis. A test for the detection of legionella or pneumococcal antigens in the urine is of value early on in the disease. The urinary antigen detects the soluble antigen for Pneumococcus and Legionella Pneumophila serogroup 1. The urine sample is collected in a sterile universal container (20ml). The specimens can be stored at room temperature (15-300C) if assayed within 24 hours of collection. Results are reported as Detected or Not Detected, on the day received in the laboratory. All Positive results are telephoned.

Limitation of the procedure:  The test will not detect infections caused by other L.pneumophila serogroups and by other Legionella species.  Excretion of Legionella antigen in urine may vary depending on the individual patient. Antigen excretion may begin as early as 3 days after onset of symptoms and persist for up to 1 year afterwards.  A positive Legionella result can occur due to current or past infection and therefore is not definitive for infection without other supporting evidence.

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 91 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

 Streptococcus penumoniae vaccine may cause false positive results in urine in the 48 hours following vaccination. It is recommended not to perform any pneumococcal antigen investigation within 5 days of receiving the S.pneumoniae vaccine.

The investigation for the Mycoplasma pneumoniae involves a serum sample (2-10 ml clotted blood) taken during acute stage. It is performed by EIA method. A positive or negative result is released within 2-3 days from the time the sample is received in the laboratory. All Positive results are telephoned. This investigation needs to be discussed with the medical staff.

Limitation of the procedure:  Samples obtained too early during infection may not contain detectable levels of IgM antibody. If M.pneumoniae infection is suspected, a second sample should be obtained in 7- 14 days and tested.  Significance of test results of immunosuppressed patients may be difficult to interpret.  Positive test results may not be valid in patients who have received blood transfusions or other blood products within the past several months  Specific IgM antibodies to M.pneumoniae are usually detected in patients with recent primary infection. However, they may be found in patients with reactivated or secondary infections and are sometimes found in patients with no other detectable evidence of recent infection. In addition, IgM to M.pneumoniae has been shown to persist for extended periods(2-12 months) in some patients.

Bronchiolitis in neonates Epidemics of respiratory syncytial virus occur each year in the autumn and winter. It has also been implicated in apnea in infants, otitis media, heart disease and acute exacerbation of chronic bronchitis. Disease is more severe in infants and young children than in older people. Samples are identical to those taken for Flu A & B (see below) and the PCR test incorporates Flu A, B as well as RSV. Under certain circumstances (such as limited availability of the PCR or urgency of the diagnosis) you may be advised by the Microbiology doctors to take a Nasopharyngeal aspirate (NPA) instead of a swab. These samples can be stored at room temperature for up to 4 hours, or at 2-80C for up to 24 hours. Test are performed using an immunochromatography assay. Reports are released within 1-2 days from the day it was received in the laboratory. Results are reported as Detected or Not Detected. All Positive results are telephoned.

Limitation of the procedure:  Test performance depends on the antigen load in the specimen.  Inadequate specimen collection or low levels of virus shedding may yield false negative results.  Palivizumab causes interference in detecting the RSV antigen.  Monoclonal antibodies may not detect all antigenic variants or new strains of RSV.

Rapid tests for para-influenzae is not currently performed as a routine. This will change in line with national policy during epidemic or pandemic periods. In this event, please send nose and throat samples using the viral e-swab.

Covid-19 Coronaviruses are a large family of RNA viruses which may cause illness in animals or humans. In humans, several coronaviruses are known to cause respiratory infections ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS). The recently discovered coronavirus SARS-CoV-2 causes coronavirus disease COVID-19 and was first observed in Wuhan, China.

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 92 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

 SARS-CoV-2 PCR testing A combined nose and throat e-swab is the recommended sample type; however, the procedure has also been validated by PHE for UTM and VTM media. Deep aspirates have not yet been validated for use; contact a member of the microbiology medical team if testing on deep aspirates is required. Samples are tested using a SARS-CoV-2, Influenza and RSV 8-well multiplex-tandem polymerase chain reaction (MT-PCR) for the enrichment of targets and then amplification of targeted DNA and/or RNA. Limitation of the procedure: • Test performance depends on the antigen load in the specimen. • Inadequate specimen collection or low levels of virus shedding may yield false negative results. • Other substances such as ethanol, ethanol-based products or mucin might be inhibitory. The nucleic acid controls included in the test will detect interference caused by the sample. Turnaround times: 15 hours from sample receipt in the laboratory or 24 h from the sample being taken. Results are reported as Detected (alongside Ct values), Negative or Invalid. A sample is considered positive when at least one of the targets is present. For low positive samples (Ct>30), or samples where only one of the SARS-CoV-2 targets is present (a or b), a repeat test is performed.

 Fast Track Covid-19 testing (SAMBA): A rapid RT-LAMP (reverse transcription Loop mediated Isothermal Amplification) covid-19 test is available but limited to certain users in order to manage capacity. The agreed pathways are as follows: 1 – Emergency surgery under GA. 1 – Mother of baby for admission to NICU. 1 – ITU admission: low-suspicion COVID. 2 – AAU ONLY: Consultant Request (enter details into ICE). 2 – Bed blockage on labour ward to aid transfer of patient to Cellier Ward. 2 – Mission Critical request by Microbiology Team (enter details into ICE). 3 – Staff swab: agreed by Silver on-call. A combined nose and throat swab using the designated SAMBA buffer is required. No other sample types will be accepted. Swabs will be delivered to and stored in two areas for stock control: Mary Seacole South Ward Manager office and Labour Ward. Please ensure an e-swab for PCR is sent alongside the SAMBA test. Fast Track Sample Request (C-19 red sample bag) must be walked and delivered to the Microbiology Dept., Pathology Lab., 5th Floor, Outpatients Block, WH, for timely processing on the SAMBA II analysers. Processing times are 7:30 to 18:00. Limitation of the procedure: • Test performance depends on the antigen load in the specimen. • Inadequate specimen collection or low levels of virus shedding may yield false negative results. Turnaround times: 4 hours once the sample is received in the laboratory. Samples must always be handed in to a member of the microbiology team. Results are reported as Detected, Negative or Invalid. A sample is considered positive when at least one of the targets is present. Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of active infection. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with PCR results, clinical observations, patient history, and epidemiological information.

Influenza A & B Investigation for Flu A & B is seasonal, with its highest incidence during the Flu season (November till March). The test used also incorporates RSV and it is the standard first line test for this virus. Influenza most commonly affects infants and young children. Adults may also be affected with the highest risk for disease severity and mortality among the elderly. A combined nose and throat swab collected using the e-swab is sent to the laboratory. This procedure is performed after discussion with

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 93 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

the medical staff. Results are available within 1-3 days of receipt in the laboratory. It is reported as Detected or Not Detected and all Positive results are telephoned.

Limitation of the procedure:  The strain H7N9 is not detected with the current assay available in the laboratory.  The detection of the viral nucleic acid is dependent upon proper specimen collection(standard procedure for internal nose swab, using only the e-swab), handling, transportation, storage (transported to the lab as soon as possible or stored at 2-8 oC for up to 72 hour prior to testing) and preparation in the laboratory.

10 Skin, Hair and Nails Investigation for Dermatophyte The dermatophytes are specialised parasites of keratin and belong to the genera Epidermophyton, Microsporum and Trichophyton. The table below shows the most common dermatophytes isolated.

Species Usual site of infection Epidermophyton floccosum Groin, Feet Microsporum audouinii Scalp Trichophyton interdigitale Feet, Nails Trichophyton rubrum Feet, Groin, Nails, Trunk Trichophyton schoenleinii Scalp Trichophyton soudanense Scalp, Face, Trunk, Limbs Trichophyton tonsurans Scalp, Face, Trunk, Limbs Trichophyton violaceum Scalp, Face, Trunk, Limbs

Skin, hair and nails for mycology are examined microscopically for fungal elements using a fluorescent brightener with an affinity for fungal elements. The samples are then cultured on Sabouraud’s medium with chloramphenicol and also on media selective for dermatophytes. The plates are incubated for 4 weeks, being examined at weekly intervals. Any colonies grown are examined macroscopically and microscopically to identify the species. A preliminary report for fungal microscopy is made available within one week from the time the sample is received in the laboratory. If the culture is negative after 4 weeks of incubation it is reported as “No pathogenic fungi isolated”. If the culture is positive, it will be reported as “Growth of …… (Named dermatophyte)”. If the culture media is contaminated “Culture is overgrown with contaminants”

Specimen collection Samples should be collected into folded dark paper squares (e.g. Dermapak). It should be kept at room temperatures. Refrigeration of the sample is not advisable as low temperature inhibits dermatophytes and humidity facilitates the growth of contaminants. Swab samples for dermatophyte investigations are of little value.

Skin scrapings  Scrape skin from the active margin of lesion using a blunt scalpel or similar. At least 5 mm of skin flakes are needed for microscopy and culture

Nail samples  It is better for clinicians to take the samples than the patients

 Most viable fungi are usually found in most proximal part of diseased nail. Use a chiropody scissors for sampling. Include full thickness clippings of the diseased nail. Also sample debris from under the diseased part of nail.

 In superficial infections scrape surface of diseased nail plate with scalpel.

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 94 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Hair Samples  Take scalp scrapings- this often pulls out infected hair stumps which are critical for successful culture & microscopy. Hair plucking does not produce the best samples.

 A soft toothbrush can be used if scrapings are not possible.

11 INVESTIGATION OF GENITAL INFECTIONS Vaginal infections Microbial associated vaginal symptoms can be subdivided into vaginitis and Bacterial Vaginosis (BV). The organisms most commonly responsible for vaginitis are candida and Trichomonas vaginalis. A high vaginal swab is sent to the laboratory for diagnosis of vaginal symptoms. In pregnant women, Group B streptococci are always screened for and reported. This organism is not a recognised cause of vaginitis but is reported to help prevent neonatal invasive disease. Women in labour who are known to be carriers of group B streptococci at onset of labour should be given parenteral amoxicillin as prophylaxis against group B streptococcal disease in the neonate. Gram’s stain for Hay’s criteria (for BV) and Trichomonas culture are only performed on samples with relevant clinical details. A negative culture is reported as “Candida sp. Not isolated”. If a clinically significant organism is isolated, the organism is quantified and sensitivities will be performed if applicable. Sexually Transmitted Infection (STI) STI is most commonly caused by Chlamydia trachomatis, Neisseria gonorrhoea (both diagnosed by NAAT testing – see below) and Trichomonas vaginalis. Bacterial Vaginosis Non-specific Bacterial vaginosis (which is, strictly speaking, not an infection) is generally accepted as being not sexually transmitted and is usually a clinical diagnosis. The patient will have a grey frothy, malodorous discharge with pH greater than 5.5. The amine test is usually positive. Laboratory indicators of non-specific vaginosis are (usually the absence of pus cells): reduced numbers of lactobacilli, the presence of raised numbers of curved gram negative rods, Gram variable rods and/or other bacterial morphotypes; this is reported as Hay’s criteria I, II, or III. There is some evidence that non-specific vaginosis is associated with premature rupture of membranes in pregnant women.

Swabs for Culture and Sensitivity  High Vaginal swab (HVS) is taken by a trained clinician

 Label the swab with patient name, NHS or hospital number, date of birth, date and time of collection.

 Sample should be stored at 2-300C and should be sent to the as soon as possible.

The turnaround time (TAT) for these culture tests is 3 working days from time of receipt in the laboratory.

For NAAT (Nucleic Acid Amplification Test) testing – a low vaginal swab, or a first catch urine sample may be used to test for Chlamydia and Gonorrhoeal infections. The swab must be the purple BD swabs supplied for this purpose; they may be self-taken. In the male (as also sometimes in the female), urethral, rectal and throat swabs, as well as serum, may be required for the investigation of sexually transmitted diseases; these sample must be taken by a trained clinician.

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 95 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Specimen collection Urine specimen collection for NAAT testing  The patient should not have urinated for at least 1 hour prior to specimen collection.

 Collect the first 20-60 ml of voided urine (the first part of the stream) into a sterile universal container.

 Screw the lid tight. Label with patient name, NHS or hospital number, date of birth, date and time of collection.

 Sample should be sent to the laboratory as soon as possible. If there is delay, refrigerate the sample.

Self taken vulvo-vaginal swabs for NAAT testing The self-taken vulvo-vaginal swab is now considered the “Gold Standard” and should be used for all women at risk of Chlamydia or Gonorrhoea. Use of this test in patients not at risk increases the risk of false positive results.

 Remove the swab from the tube. Make sure that nothing touches the soft tip of the swab. Hold the swab about three-quarters of the way down the stick.

 Find a comfortable position to the insert the swab into the vagina. If you are using tampons, you may want to use the same position when inserting the tampon.

 Gently slide the swab no more than 2 inches into the vagina. If the swab does not slide easily, gently rotate the swab as you push. If it is difficult, do not attempt to continue. Make sure the swab touches the walls of the vagina so that moisture is absorbed by the swab.

 Rotate the swab for 10-15s

 Withdraw the swab without touching the skin. Place the swab in the tube and cap securely.

 After collection wash your hands. Label the swab with the patient name, NHS or hospital number, date of birth, date and time of collection.

 Sample should be stored at 2-300C and should be sent to the laboratory as soon as possible.

The turnaround time (TAT) for these NAAT tests is 10 working days from time of receipt in the laboratory.

Limitation of the procedure for CT/GC NAAT 1. The effects of other potential variables such as vaginal discharge, use of tampons, douching, and specimen collection variables have not been determined. Additionally certain sub- populations have not been evaluated as part of the efficacy data, these include pregnant women and patents under the age of 17. 2. A Negative test result does not exclude the possibility of infection because test results may be affected by improper specimen collection, concurrent antibiotic therapy, or the number of organisms in the specimen which may be below the sensitivity of the test. 3. The assay cannot be used to assess the therapeutic success or failure since nucleic acids from N.gonorrhoeae/C.trachomatis may persist following antimicrobial therapy. 4. No interference was observed from blood, gynaecological lubricants, spermicides and commonly over-the-counter pain relievers 5. The patient collected vaginal swab specimen application is limited to healthcare facilities where support and counselling is available to explain procedures and precautions.

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 96 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

6. The assay has not been validated for vaginal specimens collected by patients at home. 7. The assay does not detect plasmid-free variants of C. trachomatis

IUCD The device should be placed into a sterile, 25 ml plastic universal container. In the case of Intra- uterine contraceptive devices, where the presence of Actinomyces is suspected or shown in the endocervical smear, separate prolonged culture techniques are required and the clinical information must be clearly stated on the request form. The culture is negative if no pathogens are isolated within 48 hours of receipt and processing. It may be reported as “No growth at 48 hours of incubation”. A “Mixed growth of doubtful significance” is reported if there are 2 or more organism present but not clinically significant. “No significant growth” is reported if the organism isolated is part of a normal flora. These negative results should be reported 2-3 working days after the sample is taken. If a significant pathogen is isolated, the organism is identified and antibiotic sensitivities reported. Significant pathogens isolated will be telephoned if they are likely to have an immediate effect on the patient outcome. If further investigation is required a preliminary report is released. Positive final results should be reported 3-4 working days after the sample is taken – unless an isolate is problematic or requires further investigation by a reference laboratory. Samples requiring prolonged culture for Actinomyces should be reported within 10-11 days of collection if negative and positive results reported within 16-17 days.

Vulval swabs Vulval swabs from children are checked for the presence of Neisseria gonorrhoeae and Group A haemolytic Streptococci. In the case of suspected sexual abuse, documented procedures and chain of custody documentation is mandatory and should be carried out after consultation with the Consultant Paediatricians. The laboratory should be notified. The culture is negative if no pathogens are isolated within 48 hours of receipt and processing. It may be reported as “No growth at 48 hours of incubation”. A “Mixed growth of doubtful significance” is reported if there are 2 or more organism present but not clinically significant. “No significant growth” is reported if the organism isolated is part of a normal flora. These negative results should be reported 2-3 working days after the sample is taken. If a significant pathogen is isolated, the organism is identified and antibiotic sensitivities reported. Significant pathogens isolated will be telephoned if they are likely to have an immediate effect on the patient outcome. If further investigation is required a preliminary report is released. Positive final results should be reported 3-4 working days after the sample is taken – unless an isolate is problematic or requires further investigation by a reference laboratory. . Herpes Investigation Herpes simplex virus type 1(HSV-1) and type 2 (HSV-2) are enveloped double-stranded neurotrophic DNA viruses that belong to the Herpesviridae family. The two serotypes, HSV-1 and HSV-2 produce infections that differ clinically. HSV-2 is transmitted sexually causing infection of genital mucosal surfaces. HSV-1 is mainly associated with transmission via oral secretions causing infection of orofacial mucosal surfaces. HSV-1 however can also cause genital herpes and has seen an increase in incident rate due to the increase of oral-genital contact. There are different laboratory techniques available in identifying HSV infection. The method available in this laboratory is PCR. The external anogenital lesion specimen for the HSV Amplified DNA assays are collected with either the BD Probe Tec™ Qx Collection Kit, for Endocervical or Lesion Specimens, or the e-swab. Samples can be stored at 2-300C and should be sent to the laboratory as soon as possible. Results are available within 5 working days from the time it was received in the laboratory. It is reported as Positive or Negative. For samples taken from other body sites such as: throat, rectal, etc., a comment that reads as “This sample type has not yet been fully validated for this test – Please interpret with caution.” is added on the report.

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 97 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Limitations of the Procedure: 1. It does not detect or differentiate any other Herpes virus types. 2. There is a risk of false negative results due to presence of sequence variants in the targets of the assay. 3. HSV viability and/or infectivity cannot be inferred from a positive test result because target DNA may persist in the absence of infectious virus. 4. A negative test does not exclude the possibility of infection because test results may be affected by improper specimen collection/transport/handling, presence of inhibitors, concurrent antiviral therapy, or the presence of insufficient DNA for detection. 5. The effects of other potential variables such as vaginal discharge, use of tampons, douching, and specimen collection variables have not been determined. Additionally certain sub- populations have not been evaluated as part of the efficacy data, these include pregnant women and patents under the age of 17.

Container/ Specimen How to collect minimum vol. Bartholin's abscess 1. Disinfect skin. Sterile universal 2. Aspirate fluid from ducts. container.

12 SEMEN ANALYSIS The laboratory provides an appointment service for both post-vasectomy samples and for investigation of infertility. This technical service is complimented by clinical interpretation and advice, provided by Dr Gidon Lieberman - Lead Consultant for Clinical Andrology (Women’s health Department) on 020 7288 3314. Patients must be given clear verbal and written instructions on how to produce and deliver these samples (a comprehensive set of instructions is available by e-mail on request). The specimen must be kept at body temperature and delivered to the laboratory within 1 hour of its production (or 4 hours for first time post vasectomy samples). The laboratory is able to receive these samples by appointment from 9.00am to 2.00pm, Monday, Wednesday, Thursday & Friday only. For GP patients the Choose and Book system is used for making appointments; the process is as follows:  Logon to either the 'EMIS' or 'Vision' system and go to 'eReferral'  Enter 'Gynaecology' as the speciality and 'Infertility' as the clinic  'Search all'  Select 'Andrology semen testing service'  **Please add a note indicating whether an infertility or post vasectomy request** For internal hospital appointments a clinic referral should be made through the Medway system to the ‘Fertility clinic – GL1SA’ under Mr Lieberman. **As above, please add a note indicating whether an infertility or post vasectomy request** Please note appointments cannot be made for TUESDAYS, WEEKENDS or BANK HOLIDAYS.

Once an appointment has been made a pre-weighed and toxicity tested pot will be sent (or handed) to the patient along with a comprehensive set of instructions (available by e-mail on request). It is essential that only these special pots are used for any semen analysis test.

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 98 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Infertility Investigation Semen Analysis is conducted as part of an initial assessment for infertility. Infertility is defined by NICE guidelines as the period of time people have been trying to conceive without success. The normal values for this investigation are taken from: Cooper et al (2009). Human Reproductive Update Advance Access December 2009. World Health Organisation reference values for human semen characteristics are Volume: 1.5 ml or more

Sperm 15x106 spermatozoa/ml or more Concentration: Total Sperm Count: 39x106 or more per ejaculate

Motility: 40% or more motile (or 32% or more with progressive motility) within 60 minutes of ejaculation

Normal forms: 4%

PH: 7.2 or more

Vitality: 50% or more live, i.e., excluding dye

The volume, degree of motility, Count, liquefaction, pH, and vitality is measured in Microbiology and a preliminary report issued on receipt of sample. The sample is then passed to Cytology for assessment of abnormal forms and a final report issued, usually about 2 weeks after first receipt of the specimen.

Factors that may affect adversely affect the results of the Investigation  Abstinence period not being adhered to can result to in lower counts.  Incomplete sample collection can result in a lower sample volume being recorded.  Spermicidal agents coming into contact with the sample can reduced the motility/vitality results.  Inaccurate time written on the form/sample for the time produced can result in the wrong interpretation of the motility/vitality results.  Improper storage of sample in transit to the laboratory (i.e. chilling) can reduce the vitality and motility results.  Delay in transporting the sample to laboratory.  Screw lid not secured properly resulting in sample leakage.

Post Vasectomy Please ensure that the patient has a request form to present with the sample – clearly stating that the request is for post vasectomy analysis (forms and comprehensive instructions are available by e- mail on request). The British Andrology Society guidelines for the assessment of post vasectomy semen samples recommend that initial assessment is undertaken 12 weeks post vasectomy and after the patient has produced at least 20 ejaculates. The seminal fluid is examined for the presence and absence of spermatozoa by direct microscopy within 4 hours of production, or within one hour in the case repeat samples to detect motility - should spermatozoa be present in the first sample. The whole ejaculate should be submitted to the laboratory and collected in a sterile universal container. The sample should be handed to the

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 99 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

laboratory staff within four hours from the time it was produced - if it is the first sample, or within one hour for repeat samples. Results are released on the day of receipt of the sample. It may be reported as: No spermatozoa seen, Motile spermatozoa seen, or Non-motile spermatozoa seen Effective sterilisation can be achieved even when the greatly reduced count remains above zero (<100,000/ml) provided the sperm are non-motile. In these ‘special clearance’ circumstances it is dependent upon the judgement of the suitably qualified clinical specialist dealing with the case to grant clearance or ‘special clearance’ and advise the patient that the sterilisation was successful; this should only be given after assessment of two samples (or more at the discretion of the clinician), the second of which must be examined within 1 hour. It is important that the patient continues to use alternative means of contraception after the operation until they are advised otherwise by the clinician.

VIRAL ISOLATION

Samples for most Viral PCR requests are forwarded to Reference Laboratories. Where possible these samples should reach the laboratory before 10.00 hrs. We have transport that delivers these specimens to the reference laboratories at 10.30hrs Monday to Friday. As with all requests it is important to give full clinical details. Prior discussion with the medical staff will ensure that the most appropriate samples are sent. Test Sample Type Referred to Comments Results

Cryptococcal CSF Clinical This test has to be antigen Microbiology authorised by microbiology and Virology registrar/consultant UCLH NHS Foundation Trust 60 Whitfield Street London W1T 4EU

Norovirus PCR Faeces Clinical This test has to be Not Detected Microbiology authorised by microbiology Positive and Virology registrar/consultant/infection UCLH NHS control. Foundation Where applicable this may Trust be performed locally. 60 Whitfield Street London W1T 4EU

Respiratory PCR Swabs (Nose Clinical This test has to be Not Detected and Throat) Microbiology authorised by microbiology Influenza A RNA Positive and Virology registrar/consultant.

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 100 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Influenza B RNA NPA UCLH NHS Where applicable Influenza Foundation A RNA & Influenza B RNA RSV RNA Trust may be performed locally. ParaInfluenza 60 Whitfield RNA Street London Metapneumovirus W1T 4EU RNA Adenovirus DNA Viral PCR Swabs Clinical This test has to be Not Detected Microbiology authorised by microbiology Herpes simplex CSF Positive and Virology registrar/consultant type 1 Faeces UCLH NHS Herpes simplex Foundation *Urine type 2 Trust Varicella Zoster 60 Whitfield DNA Street London *Cytomegalovirus W1T 4EU DNA Treponema Pallidum Epstein-Barr virus DNA Enterovirus RNA

16s rDNA PCR CSF Department of This test has to be Negative/ Not Microbiology authorised by microbiology Detected Streptococcus Body fluids registrar/consultant agalactiae Camelia Botnar Positive/ Pus Laboratories Detected Streptococcus Tissues pneumoniae Great Ormond Street Hospital Neisseria NHS Trust meningitidis London WC1N 3JH

SEROLOGY/IMMUNOLOGY

A Serology test is requested to measure the antibody level in a plasma or serum sample as a result of exposure to a particular bacterium or virus. Immunology tests are requested to investigate autoimmune and allergic diseases. The most frequently requested investigations are performed in our own laboratory, daily in some cases. Tests are sent to a reference laboratory when the numbers to be tested are too small to allow economic testing with adequate quality control or the techniques are not applicable to routine use. Tests sent away usually take two-three weeks to be reported. Except where otherwise stated, most tests require 5-10 ml of clotted blood. Please complete a Pathology request form. It is important to give full clinical details with such requests including any contact or immunisation dates.

100

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 101 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Tests not performed in-house and positive results requiring confirmation are sent to national reference centres as follows: (The length of time before the result is returned varies from test to test depending on the time taken for the Royal Mail to deliver the sample and return the result and the frequency with which the reference laboratory performs the test. As a general rule - two weeks should be allowed before a result can be expected, although in practice results are often returned considerably sooner). Unless otherwise stated – all samples are retained for a minimum of three weeks – additional tests can be requested during this period.

101

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 102 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Test Name Clinical Indication/Risk Factors Sample Results/ Reference Laboratory Type Normal Range

Acetylcholine Receptor Useful in the diagnosis of myasthenia gravis. Clotted 0- 0.45 nmol/L OxfordNHS Trust Antibodies blood Negative in ocular myasthenia, Eaton-Lambert Immunopathology syndrome and in generalised myasthenia gravis if 2 – 10 ml Department treated or inactive. Turn-around time: 1 – 2 weeks Adenovirus Upper respiratory tract infection, childhood pneumonia, Clotted UCLH diarrhoea blood Department of Virology 2 – 10 ml Turn-around time: 2-3 weeks Adenovirus Viral Load Discuss with Microbiologist registrar ext.5085 EDTA Not Detected Clinical Microbiology 2-10 ml And Virology UCLH NHS Foundation Trust

Turn-around time: 1 – 2 weeks Adrenal cortex antibody High antibody titres are characteristic of autoimmune Clotted Negative Barts and London NHS hypoadrenalism in about three fourth of cases but they blood Positive Trust are not found in tuberculous Addison’s disease. 2 – 10 ml Immunopathology When positive other steroidal cell antibodies (Testes or Department Ovary) should be checked. Turn-around time: 1 – 2 weeks

102

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 103 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Amikacin Level Please refer to therapeutic drug monitoring Clotted Please refer to therapeutic drug Antibiotic Assay blood monitoring Laboratory 2 – 10 ml Bristol Turn-around time: 1 – 3 days * Interim report from the reference laboratory is received through telephone

Amoebic Antibody Always check in-patients with a liver abscess, Clotted The Department of Screen dysentery or a relevant history. blood Clinical Parasitology Must be checked on newly diagnosed inflammatory 2 – 10 ml The Hospital of Tropical bowel disease before treatment with steroids. Disease Turn-around time: 1 - Stool examination should also be performed. 2 weeks Antenatal Screen All pregnant women at booking are screened for Clotted In house Test Total Syphilis Syphilis antibodies, Hepatitis B surface antigen and blood Turn-around time: 1 – Detected HIV (unless they have elected to opt out) as part of the 2 – 10 ml 2 working days IDPS screening programme. Not Detected * The laboratory has to For more information visit: Hepatitis BsAG be notified for Urgent https://www.gov.uk/government/publications/infectious- Not detected samples. Results are diseases-in-pregnancy-screening-programme- Hepatitis B markers to follow telephoned to the handbook requesting team. HIV * This assay is run daily

103

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 104 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Negative * Positive results are Positive notified by microbiologist registrar If screening is positive for Infectious diseases, a further and consultant serology test is done to confirm results.

Samples are kept for 2 years; additional tests can be requested during this period.

At present, testing for Toxoplasma antibodies is performed only at patient’s request. It is not a current recommendation to test all pregnant women for toxoplasmosis in United Kingdom.

Anti-Amphiphysin Stiff person Syndrome or paraneoplastic neurologic Clotted Negative Immunology syndrome (when some patients will also be Hu Ab blood Department positive 2 – 10 ml Churchill Hospital Oxford Turn-around time: 2 – 3 weeks Anti-basal ganglia Post-streptococcal movement and psychiatric disorder Clotted Negative Barts and London NHS antibody blood Trust 2 – 10 ml Immunopathology Department

Turn-around time: 2 – 3 weeks

104

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 105 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Anti-CCP Highly specific for rheumatoid arthritis and can be Clotted 0–10 U/ml In house Test detected in very early stages of the disease. blood Turn-around time: 1 – Should only be tested by rheumatology with clinical 2 – 10 ml 3 working days suspicion or diagnosis of RA * This assay is run 4x a week

Anti-cholinesterase Musk and AchR negative myasthenia gravis. Note Clotted Negative Immunology Antibody high false positive rate in healthy individuals blood Department 2 – 10 ml Churchill Hospital Oxford Turn-around time: 2 – 3 weeks

Anti-double stranded This test is confirmatory for SLE. Elevated levels occur Clotted 0-10 U/ml In house Test DNA predominantly in SLE, but also in “lupoid” chronic active blood Turn-around time: 1 – 3 hepatitis. 2 – 10 ml Immunofluorescence results working days

These antibodies are not found in other connective tissue * This assay is run daily diseases, nor in all patients with SLE. Negative Positive Because the antibodies have a circulating half-life of three weeks, serial measurement is not useful in Barts Health NHS Trust monitoring the activity of SLE. for confirmatory Immunofluorescence Positive results need confirmation by Immunoflouresence. Turn-around time: 1 – 2 weeks In known SLE levels are useful in monitoring, reflecting disease activity

Anti-glangioside antibody Immunologically mediated peripheral neuropathy e.g. Clotted Negative (0-200) Immunology

105

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 106 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

(GM-1/ GQ1B) Guillan Barre, Multifocal Motor Neuropathy, Miller blood Department Fisher syndrome 2 – 10 ml Bart’s London hospital Turn-around time: 2 – 3 weeks

Anti-Glomerular Goodpasture’s disease or anti-GBM nephritis. The test Clotted 0-7 U/ml In house Test Basement Membrane is useful for monitoring anti-GBM nephritis. blood Barts Health NHS Trust Negative results, however, do not rule out 2 – 10 ml * Raised anti-GBM Goodpasture’s disease values are notified to the Immunologist consultant and/or requesting clinician.

Anti-Glutamate Receptor Limbic Encephalitis. Clotted Negative Immunology Antibodies blood Positive Department Note other antibodies LGI1, CASPR2, contactin-2 (anti-AMPA1/anti-AMPA2) (VGKC-complex antibodies), NMDA and GABAB 2 – 10 ml Churchill Hospital antibodies may also be appropriate in this context. Oxford

Turn-around time: 2 – 3 weeks Anti-mitochondrial Primary biliary cirrhosis (PBC) Clotted * Confirmatory M2 is antibody blood Anti-M2 performed on sample Only M2 subtypes, confirmed by solid phase assay are Not detected associated with PBC, other antibodies may arise non- 2 – 10 ml that are positive on Detected Immunofluorescence. specifically in infection and other forms of hepatic injury e.g obstruction. Samples for Anti-M2 are sent to the reference laboratory for

106

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 107 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

confirmation. Barts and London NHS Trust Immunopathology Department

Turn-around time: 1 – 2 weeks

Anti-MUSK Antibody AchR Ab negative Myasthenia Clotted Negative Immunology blood Department 2 – 10 ml Churchill Hospital Oxford Turn-around time: 2 – 3 weeks

Anti-myeloperoxidase Positive in ANCA Associated Small Vessel Vasculitis Clotted 0.2 – 3.5 U/ml In house test (MPO) (SVV) blood * The laboratory has to performed as part of the primary ANCA screen 2 – 10 ml be notified for Urgent samples.

107

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 108 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

* Raised level of Anti- MPO is telephoned to the Immunologist Consultant/ Requesting Clinician * This assay is run daily Anti-Nuclear Antibody Diagnostic of a variety of connective tissue disorders Clotted Negative In house Test IF slide confirmation Negative (ANA) e.g SLE, MCTD, Sjogren’s, but low positives blood Turn-around time: 1 – Positive 1/100 +/++/+++ commonly seen in infection and with increasing age 2 – 10 ml 3 working days (Diffuse,Speckled, Nucleolar, (Screening) Screening is done by EIA method. If sample tested Centromere) Positive, a confirmatory test by Immunofluorescence * Screening is will be performed. Samples are diluted at 1/100 and Positive 1/1000 (Diffuse, Speckled, performed 4x a week 1/1000. Nucleolar, Centromere) Turn-around time: 1 – If sample proves to be positive on confirmatory test 2 weeks (Confirmation ENA will also be tested. ds-DNA will also be measured by immunofluorescence) * Immunofluorescence is performed twice a week

Anti-Neuronal Antibodies Paraneoplastic Neurologic Syndromes Clotted Barts and London NHS (anti-yo (purkinje) /hu/ ri) blood Trust 2 – 10 ml Immunopathology Department Turn-around time: 2 – 3 weeks

108

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 109 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Anti-Neutrophil ANCA Associated Small Vessel Vasculitis, including Clotted ANCA IF Negative In house Test c ANCA IF Positive Cytoplasmic Antibody Granulomatosis with Polyangitis and Allergic blood Turn-around time: 2 – p ANCA IF Positive (ANCA) Granulomatosis. 2 – 10 ml 7 Days Atypical ANCA If positive for anti-MPO and anti-PR3.Then this * This test is done twice Immunofluorescence test with be carried out to confirm a week MPO/PR3 findings All patients with known or suspected vasculitis should have renal function and urine dip and any abnormalities discussed with the renal team

Anti-NMDA receptor Limbic Encephalitis, but note that other antibodies Clotted Negative Immunology antibodies including AMPA, VGKC and GABAb may also be blood Department indicated 2 – 10 ml Churchill Hospital Oxford Turn-around time: 2 – 3 weeks Anti-NMO Neuromyelitis Optica Clotted Negative Immunology This is an NSCAG funded test offered at Oxford. blood Department 2 – 10 ml Churchill Hospital Clinical details are required including MRI findings and clinical features Oxford Turn-around time: 2 – 3 weeks

Anti-proteinase 3 (PR3) done for primary ANCA Screening. Clotted 0.2 - 2 U/ml In house Test blood. Seen in c-ANCA, Wegener’s Polyangitis with * The laboratory has to 2 – 10 ml be notified for Urgent

109

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 110 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

granulomatosis. samples. Titres fall with treatment and may predict flares, * Raised level of Anti- therefore useful in monitoring. MPO is telephoned to the Immunologist Consultant/ Requesting Clinician. * This assay is run daily Anti-smooth muscle Chronic active hepatitis, Viral hepatitis, Biliary cirrhosis Clotted Negative In house Test Weakly Positive antibody blood Turn-around time: 1 – Moderately Positive, 2 – 10 ml 3 working days Strongly Positive * This assay is run twice a week Anti-Staphylolysin O The anti-staphylolysin test has mainly been used for Clotted 2 units/ml PHE Laboratory of antibodies the diagnosis of chronic osteomyelitis, endocarditis blood Healthcare Associated where about 65% of cases give raised titres. Elevated 2 – 10 ml Infection and Antibiotic titres are also evident in joint infections. Resistance Monitoring and Reference Laboratory Turn-around time: 2 – 3 weeks

Anti-Strep DNAse ADB titres peak later than ASO levels, and remain Clotted 200 units/ml PHE Laboratory of elevated for several months. The ADB can therefore blood Healthcare Associated be of value if there is a delay in diagnosis, or if there is 2 – 10 ml Infection and Antibiotic a long latent period between infection and post- Resistance infective complications (as may be the case in Monitoring and Sydenham's chorea). Reference Laboratory Turn-around time: 2 – 3 weeks

110

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 111 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Anti-Streptolysin-O To determine recent streptococcal infection and post Clotted 0-200 iu/ml In house Test (ASO) streptococcal complications including rheumatic fever blood Turn-around time: 1 – and glomerulonephritis. 2-10 ml 3 working days Tonsillitis, endocarditis, and osteomyelitis * This assay is run daily Aspergillus precipitins For the diagnosis of allergic bronchopulmonary Clotted Adults In house Test 0-50 mgA/l aspergillosis, aspergilloma, paranasal sinus blood Turn-around time: 1 –

aspergillosis, other forms of aspergillosis in 2-10 ml 3 weeks immunocompetent patients Under 16 0-25 mgA/l * This assay is run once a week Aquaporin-4 antibodies Neuromyelitis Optica Clotted Immunology This is an NSCAG funded test offered at Oxford. blood. Department Clinical details are required including MRI findings and 2 – 10 ml Churchill Hospital Oxford clinical features. Turn-around time: 2 – 3 weeks Autoantibodies Composite of gastric parietal, smooth muscle, liver Clotted Negative In house Test Weakly Positive kidney microsomal, mitochondrial antibodies. Please blood Turn-around time: 1 – Moderately Positive specify if liver disease or pernicious anaemia 2-10 ml 3 working days suspected Strongly Positive * This assay is performed twice a week Avian Precipitins Detection of IgG precipitating antibodies to budgerigar, Clotted Immunology parrot and pigeon antigens; blood Department For investigation of respiratory symptoms in bird 2 – 10 ml Royal Brompton

111

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 112 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

keepers Hospital Extrinsic Allergic Alveolitis, Hypersensitiivty Turn-around time: 2 – Pneumonitis 3 weeks

Β-2-glycoprotein IgG/IgM For the diagnosis of antiphospholipid syndrome if ACL Clotted Negative Barts and London NHS ab negative blood Trust Immunopathology 2 – 10 ml Department Turn-around time: 2 – 3 weeks Beta Glucan Test Cut off 80 pg/ml Bartonella (cat scratch) *Not currently available – please contact *Clotted PHE Respiratory and Antibodies Microbiology Specialist registrar for advice. blood Systemic Infection Laboratory Under certain circumstances tissue samples can be 2 – 10 ml tested with 16s rRNA gene sequencing.

Bordetella pertussis Blood samples should be taken >2 weeks after onset Clotted >70 IU/mL consistent with recent PHE Respiratory and antibodies for any individuals with a history of prolonged cough. blood infection Systemic Infection Laboratory Detection of anti-pertussis toxin (PT) IgG antibody 2 – 10 ml Turn-around time: 2 – 3 weeks Brucella Antibody Also known as Undulant fever or Mediterranean fever. Clotted PHE Laboratory Human infections arise from direct contact with blood Brucella Reference Unit infected animals and their milk or milk products. 2 – 10 ml Liverpool Pyrexia of Unknown Origin Turn-around time: 2 – 3 weeks C1 Esterase Inhibitor Hereditary or Acquired Angiodema (without urticaria). Clotted Inh level Barts and London NHS

112

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 113 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

If during an attack of angioedema, the C4 is reduced, blood 150-350 Trust the C1 esterase inhibitor should be measured. 80% of 2 – 10 ml Immunopathology patients with hereditary angioedema lack the inhibitor; Inh Function Department the remaining 20% have normal or high levels of a >84 functionally inactive inhibitor Turn-around time: 1 – 2 weeks Campylobacter Not available antibodies

Candida albicans antigen Only helpful for follow-up patients with candida Clotted Negative Regional Mycology test endocarditis blood Positive Laboratory Equivocal The diagnosis of candida infection is based on 2 – 10 ml Department of isolation from infected sites. Microbiology Leeds Turn-around time: 2 – 3 weeks Chagas Foreign travel, Insect bites Clotted The Department of blood Clinical Parasitology 2 – 10 ml The Hospital of Tropical Disease Turn-around time: 2 – 3 weeks Chikungunya The disease share some clinical signs with Dengue Clotted Negative Rare and Imported and can be misdiagnosed in areas where dengue is blood Positive Pathogens Laboratory common. 2 – 10 ml Porton Down The disease occurs in Africa, Asia and the Indian Turn-around time: 2 – subcontinent. 3 weeks

Chlamydia psittaci No Longer tested for in the UK Not Available

113

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 114 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Coccidia antibodies Foreign travel, HIV, Immunosuppressed Clotted blood Bristol Mycology 2 – 10 ml Turn-around time: 2 – 3 weeks

Colistin level Please refer to therapeutic drug monitoring Clotted Please refer to therapeutic drug Antibiotic Assay blood monitoring Laboratory 2 – 10 ml Bristol Turn-around time: 3-5 working days * Interim report from the reference laboratory is received through telephone Coxiella Antibody screen Atypical pneumonia, Endocarditis in Negative blood Clotted Rare and Imported culture blood Pathogens Laboratory 2 – 10 ml Porton Down Turn-around time: 2 – 3 weeks Cryptococcal Serology HIV, Immunosuppression Clotted Negative In-house Positive blood Turn-around time: 1 – 2 – 10 ml 3 working days CSF * This test is run daily Cytomegalovirus Performed after discussion with the medical staff in Clotted Negative In house Test Positive unexplained cases of jaundice and certain neonatal blood Turn-around time: 1 –

114

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 115 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

and paediatric disease as well as AIDS and transplant 2 – 10 ml Equivocal 3 working days recipients. Deranged LFTs, Glandular fever like illness * This test is run daily Viral isolation and early antigen detection may be more * Positive IgM results appropriate. are notified by microbiologist registrar/consultant CMV PCR Confirmation of IgM Positive EDTA Not Detected Clinical Microbiology 2-10 ml and Virology UCLH Transplant patient, Severe Immunosuppression NHS Foundation Trust Turn-around time: 1 – 2 weeks

Cysticercosis Serology Clotted Negative The Department of blood Clinical Parasitology 2 – 10 ml The Hospital of Tropical Disease Turn-around time: 2 – 3 weeks Dengue fever Dengue fever or 'break bone fever' is a viral illness that Clotted Negative Rare and Imported is transmitted by the day-biting, Aedes mosquitoes. blood Positive Pathogens Laboratory Porton Down The chance of contracting DF is determined by several 2 – 10 ml factors including travel destination, length of exposure Turn-around time: 2 -3 in endemic areas, the intensity of dengue weeks transmission, and the season of travel. Risk is thought to be higher during periods of intense mosquito feeding activity two to three hours after dawn and during the early evening)

115

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 116 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Diphtheria antibodies To help confirm a clinical diagnosis. For assessment of Clotted PHE Respiratory and individual or population immunity and for investigation blood Systemic Infection of responses to immunization in selected individuals. 2 – 10 ml Laboratory Turn-around time: 2 – 3 weeks

Enterovirus antibodies Myocarditis, Pericarditis, Neurological history, Acute Clotted Epsom/Surrey (includes Coxsackie A&B, Disseminated Encephalitis blood Echovirus) 2 – 10 ml Epstein-Barr Virus LFTs deranged, Paediatrics Patient, Clotted Negative In house Test Positive blood Turn-around time: 1 – Monospot Negative result, Comparable history Equivocal 2 – 10 ml 3 working days * This assay is run daily

EBV PCR Transplant Patients, Severe Immunosuppression Referred Not Detected Clinical Microbiology Test and Virology EDTA UCLH NHS Foundation 2-10 ml Trust Turn-around time: 1 – 2 weeks

Extractable Nuclear Routinely typed are SSA/Ro, SSB/La, Sm, RNP, Jo-1 Clotted Negative In house Test Antigen (ENA) and SCL-70. These are associated with SLE, blood Positive SSA,SSB,Sm,RNP,Jo-1 or Turn-around time: 1 – 2 Sjogren’s, Mixed connective tissue disease, Systemic 2 – 10 ml SCL-70 weeks Sclerosis and Myositis syndromes. Other ENA are available by discussion with Immunology * This assay is run once a week

Barts Health NHS Trust

116

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 117 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

for Referred ENA Turn-around time: 1 – 2 weeks Filariasis For diagnosis of Tropical Pulmonary Eosionophilia Citrate The Department of blood Clinical Parasitology

4 ml The Hospital of Tropical Day blood Disease local time (12-2pm) for Turn-around time: 2 – Loa Loa 3 weeks

Night blood local time

(24-2am) for W.bancrofti

Flucytosine level Please refer to therapeutic drug monitoring Clotted Please refer to therapeutic drug Antibiotic Assay blood monitoring Laboratory 2 – 10 ml Bristol Turn-around time: 3 - 5 working days * Interim report from the reference laboratory is received through telephone

117

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 118 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

GAD 64 (islet cell abs) Elevated in Stiff Person Syndrome and patients with or 0-5 kU/L Barts Health NHS Trust at risk of Type 1 diabetes Clotted Immunology Laboratory blood. Markers 1A2 & ZN18 2 – 10 ml Turn-around time: 1 – 2 weeks Galactomannan Invasive Pulmonary Aspergillosis, Immunosuppressed, Clotted In house ITU patients blood Turn-around time: 2 -3 2 – 10 ml days Gastric parietal cells Gastric parietal cell antibodies are found in-patients with Clotted Negative In house Test Weakly Positive Antibody pernicious anaemia and also occur in-patients with blood Turn-around time: 1 – Moderately Positive thyroid autoantibodies who may not be B12 deficient. 2 – 10 ml 3 working days Their presence should lead to a check for intrinsic factor Strongly Positive antibodies. * This assay is run twice a week Diabetes, Addison’s disease, Graves disease, Thyrotoxicosis, Hashimoto’s thyroiditis, Iron deficiency anaemia.

Gentamicin Level Please refer to therapeutic drug monitoring Clotted Please refer to therapeutic drug In house Test monitoring blood Turn-around time: 1 – 2 – 10 ml 2 days * This assay is run daily.

118

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 119 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Glycine receptor antibody Paraneoplastic Neurological Syndrome Clotted Immunology blood Department 2 – 10 ml Churchill Hospital Oxford Turn-around time: 2 – 3 weeks Haemophilus influenza Functional Antibody assessment is useful in the Clotted Barts Health NHS Trust type B antibody assessment of immunodeficiency. In vaccines this blood Turn-around time: 2 – represents a T-dependent B-cell response, not innate 2 – 10 ml 3 weeks polysaccharide

Hantavirus Antibody Travel history, Severe Respiratory Infection, Clotted Rare and Imported Haemorrhagic fever, Renal Failure blood Pathogens Laboratory 2 – 10 ml Porton Down Turn-around time: 2 – 3 weeks Hepatitis A IgM Acute Hepatitis, Deranged LFT’s, Travel history Clotted Negative In house Test Positive blood Turn-around time: 1 – 2 – 10 ml 3 working days * This assay is run daily * Positive results is notified by microbiologist registrar and consultant Hepatitis A Total This assay currently available for Sexual Health Clotted Negative In house Test Positive Patients (SASH), Discuss with Micro blood Turn-around time: 1 – Equivocal 2 – 10 ml 3 working days * This assay is run daily Hepatitis B core Total Screening Test Clotted Negative In house Test blood Positive

119

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 120 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

2 – 10 ml Equivocal Turn-around time: 1 – 3 working days * This assay is run daily

Hepatitis B surface History of IVDU, sexual contact, receipt of blood and Clotted Detected In house Test Not Detected antigen blood products, dialysis, abnormal liver function test, blood Turn-around time: 1 – jaundice, needle-stick injury 2 – 10 ml 3 working days * This assay is run daily * The laboratory has to be notified for Urgent samples. Results are telephoned to the requesting team. * Confirmed positive results are notified by microbiologist registrar/consultant

Hepatitis B surface To check for immunity post vaccination. Clotted Not Immune to Hepatitis B In house Test May require booster antibodies blood Turn-around time: 1 – Test will not be performed after 2-4 months after Immune to Hepatitis B booster or completion of the primary course of 2 – 10 ml 3 working days vaccination. * This assay is run daily At present, boosting is performed approximately every 5 years.

Hepatitis B markers Hepatitis B markers are performed if the blood test is Clotted Acute infection In house Test Hepatitis BsAg – Positive positive for Hepatitis B surface antigen. These includes blood Turn-around time: 1 – Hepatitis Bc IgM – Positive Hepatitis B core IgM, Hepatitis B core Total, Hepatitis 2 – 10 ml 4 working days Be antibody, Hepatitis Be antigen. Chronic Infection * This assay is run daily All markers are carried-out if the patient has no

120

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 121 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

previous clinical history. However, if the patient has Chronic infection * Positive Hepatitis B previous history not all markers will be performed. Hepatitis BsAg- Positive core IgM is notified by Hepatitis BeAb - Positive microbiologist registrar/consultant

Hepatitis B viral load Hepatitis BsAg Positive cases, to monitor response to EDTA Clinical Microbiology treatment 2 – 10 ml and Virology Hepatitis B viral load test for Hepatitis B DNA, viral UCLH NHS Foundation load, Genotype and Resistance Mutation Trust Turn-around time: 1 – 2 weeks

Hepatitis C IVDU, receipts of blood and blood products, organ Clotted Negative In house Test Positive transplants, sexual contact, needle-stick injury blood Turn-around time: 1 – If sample proves to be positive on screening, in house 2 – 10 ml 3 working days confirmation testing is performed * This assay is run daily *The laboratory has to be notified for Urgent samples. *Results are telephoned to the requesting team. *Confirmed Positive result is notified by

121

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 122 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

microbiologist registrar/consultant

Hepatitis C viral load In Hepatitis C Positive cases, to monitor response to EDTA Clinical Microbiology treatment 2 – 10 ml and Virology Hepatitis C viral load test for RNA, RNA Value, UCLH NHS Foundation Genotype Trust Turn-around time: 1 – 2 weeks Hepatitis D (Delta) Only performed after consultation with medical staff. EDTA and Clinical Microbiology Serum and Virology Infection may be acquired along with HBV (co- sample infection) or after HBV infection (super infection). UCLH NHS Foundation submitted Trust Only if Hepatitis BsAg Positive but it won’t be at the Turn-around time: 2 – performed for all samples same time 3 weeks

Hepatitis E Only performed after consultation with medical staff. Clinical Microbiology and Virology It is a waterborne disease mainly transmitted by faecal-oral route. It can be fatal on pregnant women. UCLH NHS Foundation Trust Turn-around time: 2 – 3 weeks Herpes 1&2 antibody Not offered except for Pregnancy, Recurrent Genital Clotted Manchester Virology (HSV) Herpes and SASH samples blood. 2 – 10 ml

122

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 123 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Herpes PCR Type Specific Serology, Suspected Encephalitis, EDTA Clinical Microbiology Diagnosis Genital or Oral Herpes 2 – 10 ml and Virology UCLH NHS Foundation Trust Turn-around time: 2 – 3 weeks

HHV-6 (Human herpes 6 exanthem subitum rash (roseola) EDTA Clinical Microbiology virus) 2 – 10 ml and Virology UCLH NHS Foundation Trust Turn-around time: 2 – 3 weeks Histoplasma antibodies Respiratory Illness, Foreign Travel Clotted Regional Mycology blood Laboratory 2 – 10 ml Bristol Turn-around time: 2 – 3 weeks

HTLV-1 Causes Adult T-cell Leukaemia/Lymphoma and HTLV- Clotted Clinical Microbiology 1 associated myelopathy. blood and Virology Transmitted by sexual contact, IVDU, mother to child, 2 – 10 ml UCLH NHS Foundation blood transfusion from an infected HTLV-1 donor Trust Turn-around time: 1 – 2 weeks

123

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 124 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

HTLV-1 PCR Viral load measurement for diagnosis and monitoring EDTA Clinical Microbiology of disease in individual patients infected with human T- 2 – 10 ml and Virology lymphotropic virus types 1 & 2. UCLH NHS Foundation Trust Turn-around time: 2 – 3 weeks

Hydatid antibodies If a liver mass is clinically suspicious of hydatid cysts Clotted Negative The Department of do not aspirate before the result of hydatid serology blood Clinical Parasitology are known. 2 – 10 ml The Hospital of Tropical Disease Imaging may be highly suggestive. Turn-around time: 2 – 3 weeks HIV Screening is performed with an enzyme immunoassay Clotted In house Test (EIA). A positive test is confirmed with a second EIA blood. Turn-around time: 1 – using a different antigen. If both results are positive, a 2 – 10 ml 3 working days third test is performed for differential between HIV1 or HIV2. At this point we would request a second sample *The laboratory has to on all new cases of HIV disease to reduce the risk of be notified for Urgent laboratory or transcription errors. If there is samples. Results are discrepancy on initial results it will be sent to the telephoned to the reference laboratory for further testing requesting team. * Confirmed Positive samples are notified by microbiologist registrar/consultant * This test is run daily

124

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 125 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

HIV Viral load For monitoring disease progress and therapy. EDTA Clinical Microbiology and Virology HIV Viral load test for HIV1 RNA, proviral dna, GP agg 2 – 10 ml test for HIV1, GP Agg S/CO UCLH NHS Foundation Trust Turn-around time: 2 – 3 weeks Indirect IF Pemphigus Antibodies to GP120/180 or Desmoglein are detected in Clotted Negative St John’s institute of Pemphigoid Antibodies Pemphigus Vulgaris and Bullous Pemphigoid. Where blood dermatology Foliaceous is suspected samples need to be tested on 2 – 10 ml Turn-around time: 2 – 3 additional substrates by arrangement. weeks

Influenzae A&B Discuss with Microbiologist registrar ext.5085 Clotted Not tested send swab blood 2 – 10 ml Intrinsic factor antibodies It can be detected in 50-70% of pernicious anaemia Clotted Detected Barts Health NHS Trust Not Detected patients. A negative result in a GPC Ab positive blood Refered patient has a good negative predictive value, 2 – 10 ml suggesting B12 deficiency is then dietary.

Islet cell Antibody These may be found early in the course of type I Clotted Negative Barts and London NHS diabetes mellitus, but gradually disappear with time; blood Positive Trust they are not found in type II diabetes. 2 – 10 ml Immunopathology Department Turn-around time: 1 – 2 weeks

Itraconazole level Discuss with Microbiologist registrar ext.5085 Clotted Regional Mycology blood Laboratory 2 – 10 ml Bristol

125

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 126 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Turn-around time: 1 – 2 weeks Legionella Antibody Test NOT available Send Urine sample for Urinary antigen testing

Leishmania Antibody Generally not indicated Clotted The Department of blood Clinical Parasitology Discuss with Microbiologist registrar ext.5085 2 – 10 ml The Hospital of Tropical Disease Turn-around time: 2 – 3 weeks Leptospira Antibody LFTs deranged, Flu like symptoms, Diarrhoea, Contact Clotted Porton Down with water, rivers, sewage, rats urine blood 2 – 10 ml Listeria Antibody Discuss with Microbiologist registrar ext.5085 Clotted Test not available blood 2 – 10 ml Liver Kidney Microsomal Autoimmune hepatitis type II, HCV hepatitis, Clotted Negative In house Test Weakly Positive Antibody blood Turn-around time: 1 – drug induced hepatitis, Chronic D viral hepatitis, Moderately Positive 2 – 10 ml 3 days Chronic hepatitis Strongly Positive * This assay is run twice a week Lyme Disease Screen History of tick bites, Travel history, Neurological Clotted Negative In house Test Positive symptoms blood Turn-around time: 1 – Equivocal If screening proves Positive, Sample is sent to the 2 – 10 ml 3 working days reference laboratory for confirmation (Screening) 2– 3 weeks (Positive sample sent to reference laboratory)

126

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 127 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

* This sample is run daily Mannose binding ligand Associated with increased risk of invasive infection in <75 ug/L – homozygous variant Barts Health NHS Trust children <5 years old. alleles and non-functional MBL Dept of Clinical 75-399.9 ug/L- Immunology In adults with IgA deficiency or selective antibody Functional MBL deficiency deficiency, MBL deficiency is associated with more 400-1300 ug/L- infectious complications. Heterozygous variant alleles and mild deficiency >1300 ug/L- Wild type alleles showing no deficiency Measles IgM Discuss with Microbiologist registrar ext.5085 Clotted Colindale blood 2 – 10 ml Measles IgG Discuss with Microbiologist registrar ext.5085 Clotted Negative In house Test Positive blood Turn-around time: 1 – Equivocal 2 – 10 ml 3 working days * This sample is run daily Meningococcal PCR All routine diagnostic cultures should be taken EDTA for Negative Manchester PHE MEU however antimicrobial chemotherapy must never be PCR Positive delayed. PCR and serology can be used to confirm the 4 ml diagnosis in culture negative cases.

Mumps IgM Discuss with Microbiologist registrar ext.5085 Clotted blood 2 – 10 ml Mumps IgG Discuss with Microbiologist registrar ext.5085 Clotted In house Test blood 2 – 10 ml

127

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 128 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Mycoplasma PCR Community acquired pneumonia, Atypical pneumonia Clotted Swab PCR test Refered to colindale blood 2 – 10 ml

Ovarian Antibody This test is useful for identifying primary autoimmune Clotted Negative Barts and London NHS ovarian failure as a cause of infertility and may be blood Trust found in 15 - 50% of patients with premature ovarian 2 – 10 ml Immunopathology failure. Patients may also be positive for adrenal Department antibodies.

Parvovirus Sickle cell disease, pregnant, immunocompromised. Clotted Negative UCLH for Antibodies Positive The sample is tested for IgM and IgG, if sample is IgM blood Colindale for PCR Equivocal POSITIVE or EQUIVOCAL it is sent to reference 2 – 10 ml laboratory for confirmation For Confirmation:Public Health England Colindale Pneumococcal Antibody Serotype Specific Antibodies are useful in the Clotted blood Serotype Specific Ranges. Immunology Dept assessment of primary immunodeficiency with failure to 2 – 10 ml Protective is >0.35 IU for most Addenbrookes Hospital respond to polysaccharide vaccines. serotypes Sickle cell and related immune conditions Pneumococcal PCR Sepsis, Rash, Risk groups, Asplenia, Functional or , EDTA Negative Manchester PHE MEU Equivocal Immunodeficiency, HIV 2 – 10 ml Positive Polio Antibody Discuss with Microbiologist registrar ext.5085 Clotted Colindale blood 2 – 10 ml Q Fever Atypical Pneumonia with or without relevant travel Clotted Porton Down history looking for phase I or II Antigenic Response blood 2 – 10 ml

128

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 129 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Quantiferon Antigens used in this assay are expressed by M. Green top Negative The Doctors Laboratory Positive tuberculosis, M. bovis (some strains), M. africanum Lithium Turn-around time: 1 – Indeterminate and M. kansasii. They are not expressed by BCG, M. heparin 2 weeks avium, M. scrofulaceum and most environmental tubes mycobacteria. Adherence to blood volume required is essential (see below)

Taking the Sample

1. For each patient, at least 6ml of blood must be drawn directly into a lithium heparin tube:

Rabies Antibody History of Travel to endemic country where rabies is Clotted prevalent blood 2 – 10 ml RAST The significance of a given result depends on the age of Clotted Specific Allergy In house Test 0.35-100 kUA/l (Radioallergosorbent the patient and the allergen in question, but in general blood Turn-around time: 7 test) scores of 1 are not significant. 2 – 10 ml working days Mix Allergy Specific IgE Requesting should be limited to cases where skin testing Negative is inappropriate or inconclusive. An adequate history of Positive exposure should be taken first, and the request should Specific IgE component

specify which allergens are appropriate. testing referred to Barts and London NHS Trust Where the total IgE is low [<40 kU/l in adults], RAST Immunopathology tests are unlikely to be positive and are therefore not Department indicated. A positive result does not mean that a particular allergen is responsible for clinical symptoms Turn-around time: 1 – Specific IgE available in-house:

129

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 130 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

F1(Egg white) 2 weeks F2 (Milk) F3(Fish-Cod) F4(Wheat) F14(Soya Bean) F36 (Coconut) F13(Peanuts) F201(Pecan nut) F17 (Hazelnut) F202(Cashew nut) F256(Walnut) F20(Almond) F203(Pistachio) F18(Brazil nut) E1(Cat dander) E5(Dog dander) M3(Aspergillus fumigatus) M2(Cladosporium) T3 (Birch pollen) D1 (House dust mite) GX3 (Mixed Grass pollen) TX8 (Mixed Tree pollen) WX1 (Mixed Weed pollen)

130

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 131 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

FX2( Mixed Seafood) FX1(Mixed Nuts-F13,F17,F20,F18,F36) FX22(Mixed Nuts- F201,F202,F203,F256) FX5(Mixed Food- F1,F2,F3,F4,F14) MX1(Mixed mould)

Reticulin Antibody Coeliac disease, Crohns disease, Dermatitis Clotted Barts and London NHS hepatiformus blood Trust 2 – 10 ml Immunopathology Department Rickettsial antibodies History of Rash, Travel History, Tick bite, Flea site Clotted Negative Rare and Imported blood Positive Pathogens Laboratory 2 – 10 ml Porton Down Rheumatoid factor This is a non-specific test; it detects immunoglobulins Clotted 0-14 u/ml In house Test reactive with other immunoglobulins. Rheumatoid blood. Turn-around time: 1 – factors [RFs] occur in a wide variety of conditions, 2 – 10 ml 3 working days such as viral infections, chronic bacterial infections, myelomas, lymphomas and connective tissue diseases. Healthy elderly people may also have rheumatoid factors. Rheumatoid arthritis patients may be positive or negative for RFs, but those with progressive disease usually have high titre RFs. There is little value in serial monitoring of RF, as the titre correlates poorly with disease activity: the CCP is more useful. Requesting RFs in the elderly is not helpful, as positive results do not necessarily indicate disease.

131

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 132 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Rubella IgM To diagnose recent infection. Clotted UCLH Virology blood UCLH NHS Foundation 2 – 10 ml Trust Rubella IgG To detect immunity in health care workers and women Clotted Immune In house Test Not Immune undergoing infertility treatment blood Turn-around time: 1 – 2 – 10 ml 3 working days

Salivary Antibodies Test NOT Available Test NOT Available

SARS-CoV-2/COVID-19 Detects the presence of antibodies against Covid-19 Gel tube Detected In house Test NOT Detected Antibodies (Consistent with exposure to SARS-CoV-2 at some (gold top) Turn-around time: 1 – time). Available for patients and staff 2 – 10 ml 3 working days Schistosomal Antibodies Antibody testing for patients returning from endemic Clotted Negative The Department of countries. History of Haematuria, Fever, Typical is blood Clinical Parasitoloy Lake Malawi 2 – 10 ml The Hospital of Tropical Detection of ova from clinical specimens should be the Disease first line investigation and we will only proceed to serology once we have processed 3 stool and terminal urine samples.

Streptomycin Level Please refer to therapeutic drug monitoring Clotted Please refer to therapeutic drug Antibiotic Assay blood monitoring Laboratory 2 – 10 ml Bristol Strongyloides Antibodies Eosinophilia is a strong indication. Relevant Travel Clotted Negative The Department of History blood Clinical Parasitoloy Antibody detection and demonstration of first-stage 2 – 10 ml The Hospital of Tropical rhabdiform larvae in stool samples is first line of Disease investigation and we will only process serology samples after3 stool samples have been examined for O&P.

132

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 133 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

In immuno-suppressed patients disseminated strongyloidiasis may occur and the filariform lava may be present in such sites as sputum

Syphilis Serology Sexual Health and Dementia screening Clotted Total Syphilis In house Test Not Detected blood If Syphilis Serology The first line screening test is an EIA. Where the EIA is Detected 2 – 10 ml Markers needs positive, the RPR and TPPA will be performed. The confirmation referred to RPR may be used as a guide to activity of the disease. Syphilis IgM PHE colindale When neurological involvement is suspected and the Not Detected blood serology is positive a RPR will be performed on Detected the CSF. Equivocal

TPPA Negative Positive Equivocal

RPR Negative Positive: Neat,1:2,1:4,1:8,1:16,1:32,1:64,1:128 Teicoplanin level Please refer to therapeutic drug monitoring Clotted Please refer to therapeutic drug Antibiotic Assay blood monitoring Laboratory 2 – 10 ml Bristol Testicular Antibody Antibodies to 21-Hydroxylase are associated with Clotted Barts and London NHS Autoimmune gondal failure and addison’s disease blood Trust 2 – 10 ml Immunopathology Department Tetanus Antibody Assessment of protein antibody responses in Clotted <0.01 IU/mL – Barts and London NHS

133

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 134 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

suspected immunodeficiency blood Susceptible individual Trust 2 – 10 ml 0.01-0.09 IU/mL- Immunopathology Basic level of protection Department 0.10-0.99 IU/mL- Full protective level >1.00 IU/mL – Long term protection Tissue transglutaminase Highly sensitive and specific for coeliac disease. Clotted <0.4- 10 U/ml In house Test Confirmation of new positives by Endomysial Antibody. blood Turn-around time: 1 – Titers fall slowly on gluten free diet and are useful for 2 – 10 ml 3 working days assessing adherence or resistant disease. IgA deficient patients require an IgG test available on Referred to Barts and request London NHS Trust Immunopathology Department for first time Positive samples. Tombramycin level Discuss with Microbiologist registrar ext.5085 Clotted GOSH blood 2 – 10 ml Total IgE Significantly elevated in all atopic diseases, but is not Clotted <2 kU/l In house Test diagnostic. blood Useful in monitoring response to steroids in Allergic 2 – 10 ml Bronchopulmonary Aspergillosis. Titres required prior to and during Omalizumab Therapy.

Toxoplasma IgM To detect recent infection. Paediatric sample Clotted Public Health Wales blood Microbiology 2 – 10 ml Toxoplasma IgG It is a relatively rare disease in UK. Humans are Clotted Negative In house Test Positive

134

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 135 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

infected by three major routes: swallowing food, soil or blood Equivocal Turn-around time: 1 – water contaminated with the faeces of infected cats, 2 – 10 ml 3 working days newly infected mother to the foetus, swallowing of

undercooked or raw meat that contains the cyst form of the parasite.

Toxocara Antibody Discuss with Microbiologist registrar ext.5085 Clotted The Department of blood Clinical Parasitoloy

2 – 10 ml The Hospital of Tropical Disease Vancomycin Level Please refer to therapeutic drug monitoring Clotted Please refer to therapeutic drug In house Test blood monitoring 2 – 10 ml Varicella Zoster Virus IgG Antibodies are tested in health care workers and Clotted Negative In house Test Positive immuno-suppressed patients to assess the risk of blood Turn-around time: 1 – Equivocal acquiring and transmitting this highly contagious 2 – 10 ml 3 working days disease. Active immunisation is available.

A history of chickenpox is 80% predictive Patients with chickenpox must not be sent to hospital, the risk to pregnant women and immuno-suppressed patients is very high The diagnosis is usually made clinically and only rarely is electron microscopy or viral culture required

Varicella Zoster Virus IgM Discuss with Microbiologist registrar ext.5085 Clotted Epsom blood 2 – 10 ml

Voltage gated Calcium Limbic Encephalitis. Note other antibodies such as Clotted blood Negative 0-45pmol/L Immunology Department channel AMPA, GABAB and NMDA may be indicated 2 – 10 ml Churchill Hospital

135

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 136 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Voltage gated Potassium Eaton-Lambert Syndrome (Paraneoplastic Myasthenia) Clotted blood Negative Immunology Department channel 2 – 10 ml Churchill Hospital West Nile Virus Discuss with Microbiologist registrar ext.5085 Clotted Negative Rare and Imported blood Positive Pathogens Laboratory 2 – 10 ml Porton Down Widal Test not Available. Please contact ext. 5085 for clinical advice.

Yersinia antibodies Discuss with Microbiologist registrar ext.5085 Clotted Not tested blood 2 – 10 ml

136

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 137 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

CHANGES IN SERUM COMPLEMENT LEVELS Measurement Disease C3 C4 C3d Useful SLE - remission Normal Normal/low Normal/raised Yes SLE- flare Normal/low Normal/low Raised Yes Post-streptococal G.N. Low Normal Raised Yes C3-nephritic factor Low Normal Raised Yes S.B.E. Low Low Raised Yes Serious sepsis Low Low Raised No Rheumatoid arthritis Normal/raised Normal/raised Normal No P.A.N. Normal/raised Normal/raised Normal No Wegener’s Normal/raised Normal/raised Normal No Systemic Sclerosis Normal Normal Normal No Sjogren’s Syndrome Normal Normal Normal No Type II Cryoglobulin Normal Low Normal No

NON-ORGAN SPECIFIC AUTOANTIBODIES Autoantibody Disease Association Homogenous anti- SLE, drug-induced lupus, autoimmune chronic active hepatitis, juvenile nuclear antibody chronic arthritis. Speckled anti-nuclear Ab Mixed connective tissue disease, SLE, Sjogren’s syndrome, scleroderma, polymyositis. Peripheral anti-nuclear SLE Ab Nucleolar Ab Systemic sclerosis, scleroderma. Centromere Ab CREST syndrome [Calcinosis, Raynaud’s Esophageal dysmotility, Telangiectasia]. Double-stranded DNA Ab SLE, autoimmune chronic active hepatitis. Histone Ab SLE [responsible for LE cell phenomenon] drug-induced lupus. Ribosomal Ab SLE Mitochondrial Ab Primary biliary cirrhosis rarely autoimmune hepatitis. Smooth muscle Ab Autoimmune chronic active hepatitis. [anti-actin, anti-myosin] Liver-kidney microsomal Drug induced hepatitis. Ab Rheumatoid factor Rheumatoid arthritis, Sjogren’s syndrome SLE, chronic infections, paraproteins, old age.

137

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 138 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

EXTRACTABLE NUCLEAR ANTIGENS Antigen Associated Disease sm SLE RNP SLE, mixed connective tissue disease [MCTD. La [SS-B] SLE, Sjogren’s syndrome. Ro [SS-A] SLE, discoid LE, neonatal lupus, “ANA-negative” lupus Sjogren’s syndrome. PCNA [proliferating cell SLE nuclear antigen] Scl-70 Systemic sclerosis. Jo-1 Polymyositis.

ORGAN - SPECIFIC AUTOANTIBODIES Autoantibody Disease Association Gastric parietal cell Ab Pernicious anaemia. Intrinsic Factor Ab Pernicious anaemia. Steroid cell Ab Addison’s disease, primary ovarian failure. Adrenal cell Ab Addison’s disease. Pancreatic islet cell Ab Type 1 diabetes mellitus. Acetylcholine receptor Ab Myasthenia gravis. Striated muscle Ab Myasthenia gravis & thymoma. Cardiac muscle Ab Cardiomyopathy. Glomerular basement Goodpasture’s syndrome, glomerulonephritis. membrane Ab Neutrophil cytoplasmic Wegener’s granulomatosis, microscopic polyarteritis. granule Ab

138

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 139 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

THERAPEUTIC DRUG MONITORING

. Record time of the last dose & time blood sample taken on the assay request form. . Collect samples for drug assay using the 6ml red top vacutainer tube (serum sample). . Laboratory assay service: Monday – Friday 09:00 to 14:00; Saturday – Sunday 09:00 to 11:00 . IMPORTANT: For out-of-office hours assay service, please contact Microbiology via switchboard.

ANTIMICROBIAL REGIMEN SAMPLING TIME TARGET RANGE (mg/L) Amikacin Once daily dosing Trough (pre-dose): < 5 Multiple daily dosing Trough (pre-dose): < 10 Peak (1-hour): 20 – 30 Chloramphenicol Monitoring required in: Trough (pre-dose): < 15  Elderly or <4yrs old  Hepatic impairment Peak (2-hours IV /PO): 10 – 25 Colistimethate In renal impairment Peak (30-minutes): 10 – 15 Cycloserine Monitoring required in: Trough (pre-dose): 10 – 20  Renal impairment  Dose > 500mg/day Peak (3 - 4 hours): 20 – 35  Signs of toxicity Ethambutol In renal impairment Trough (pre-dose): < 1 Peak (2 - 2.5 hours): 2 – 6 Flucytosine Cryptococcal meningitis as an adjunct to Trough (pre-dose): 25-50 (Not to exceed 80) amphotericin According to Hartford Gentamicin Once daily dosing 6 – 14 hours nomogram Multiple daily dosing Trough (pre-dose): < 2 (endocarditis: < 1) Peak (1-hour): 5 –10 (endocarditis: 3 – 5) Itraconozole In HIV & neutropaenia, Trough (pre-dose) >0.5 reduced absorption Streptomycin Tuberculosis Trough (pre-dose): < 5 (renal impairment/over 50yrs: < 1) Peak (1-hour): 15 – 40 Endocarditis Trough (pre-dose): < 3 Teicoplanin Monitoring required only Trough (pre-dose): > 10 but < 60 in certain patients (endocarditis / bone / joint: >

– see guideline 20) Vancomycin IV therapy Trough (pre-dose): 10 – 15 (complicated infections: 15 – 20)

Peak levels of aminoglycoside may occasionally be useful but should only be taken on the request of Microbiology.

139

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 140 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

HISTO/CYTOPATHOLOGY

HISTO/CYTOPATHOLOGY TELEPHONE NUMBERS

For general enquiries, such as obtaining reports, please call:

Histology Office 020 7288 5076

If you wish to discuss a specific report, please contact the pathologist named on the report in the first instance. If the reporting pathologist is not available, another pathologist will be able to provide advice or clarification of the report if required. Dr Su Ramachandra (Consultant) 020 7288 5074

For any service operational issues, please contact: 02072885071

To book a frozen section (histology), please call x5072

For results on semen analysis, please contact: 020 7288 5088 (Microbiology Department). However, if you wish to have specialist advice about a semen report, please contact: Mr Gidon Lieberman (Consultant Gynaecologist specialising in Reproductive Medicine & Surgery) Telephone: 0207 288 5117 or Email: [email protected] Cervical screening cytology, is now undertaken by Cervical Screening London (CSL). Any queries contact T: 020 7460 4851.

GENERAL INFORMATION

 The laboratory is open from 09.00hrs to 17.00hrs Monday – Friday  There is no on-call biomedical scientist service available in Histopathology/Cytology.  Always label the specimen container with the patient’s name using a BIRO (ballpoint) pen. If any other pen is used, as fixative may leak during transit, patient details on the specimen pot label may become illegible. In this situation, the specimen will be discarded if it is a replaceable sample or returned to the sender for re-labelling.  Always provide us with a full and relevant clinical history.  All reports must be taken in conjunction with the clinical findings and results of other diagnostic investigations, such as imaging or other specialist investigations.  Specimens from in-patients or out-patients, including Endoscopy, Day Treatment Centre and Imaging: If you wish the laboratory to send a copy of the report directly to the patient’s GP, please state this clearly and provide the GPs name and address details on the request form.  Specimens from General Practices: Always provide the NHS number on the request form.

140

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 141 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

HISTOPATHOLOGY INVESTIGATIONS Sending the specimen

 Most specimens should be sent to the lab in formalin (also known as “formal saline”). In general, the volume of formalin should be at least 10 times the specimen volume. It does no harm to use too much formalin; however too little formalin may hamper interpretation and delay the result. A specimen should not be crammed into a container that is inappropriately small for its size, as this will result in considerable distortion of the specimen during fixation. Specimen containers are provided by the laboratory in a variety of sizes. Avoid using universal (20 ml) pots for submitting histology (tissue) specimens.  If an infective aetiology e.g. TB is suspected, don’t forget to send tissue for microbiological investigations before adding the formalin to the specimen. If both microbiological AND histo/cytopathological examination are required on a patient’s sample, please state this clearly on the request form when submitting the sample.  If sending more than one specimen (particularly in regard to pigmented skin lesions) from a patient, send each lesion in a separate pot, clearly indicating the biopsy site for each.  Ensure the lids of the sample containers are correctly closed to minimise the risk of spillage of the formalin fixative, particularly during transport to the laboratory. Do not use adhesive tape or sticking plaster on the lids of the white plastic containers.

Availability of formalin containers

Hospital users: For collection of containers from the laboratory please telephone x 5072. If a large number of formalin-filled pots are required (e.g. for Endoscopy, Dermatology, Colposcopy), please provide the laboratory with at least half a day’s notice and arrange a collection time. Primary Care Users: Call specimen reception on 0207 288 5754 to order for van delivery. Forms are available to order formalin containers as well as other pathology consumables by using the same number. We regret that they cannot be posted. Request Forms

Hospital users: Please use Sunquest ICE electronic forms. Printed hospital combined Microbiology/ Histo/Cytology request forms can, however, still be obtained from the Histopathology department for a limited period (call x5072). Primary Care users: Please use the printed GP combined Microbiology/ Histology/ Cytology request forms (call 020 7288 5754 to obtain a supply). This has been recently updated to accommodate the patient’s NHS number.

When will the result be available? The laboratory is highly conscious about the need to turnaround specimens in the shortest time possible but without, however, compromising diagnostic accuracy and patient safety. Turnaround times (TAT) are closely monitored by the laboratory management on a regular basis and this information is available to service users if required.

All diagnostic biopsies will be reported as soon as possible and timely delivery to the laboratory is, therefore, essential to minimise any delay in the processing and reporting of the specimen by the pathologist. Diagnostic biopsies include breast core biopsies (including hormone receptor status), bronchial, lung and pleural biopsies, skin punch biopsies, prostate core biopsies, bladder biopsies, lymph node biopsies, cervico-vaginal punch biopsies, endometrial biopsies, liver biopsies and endoscopic GI biopsies. The recommended reporting TAT standard is as follows: 80% in 7 calendar days (or 5 working days, from date of biopsy procedure).

141

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 142 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

For technical reasons, medium-sized to larger specimens (which comprise the majority of excision specimens from a variety of sites and including both cancer and non-cancer resections) will take longer to process and report. Some types of resections, such as those undertaken for colorectal cancer, require fixation for a minimum of three days before cut up and processing. However, for all histology specimens (apart from those requiring decalcification – see below), the laboratory aims to achieve the recommended TAT standard as follows: 90% reported within 10 calendar days from date of procedure.

Specimens containing bone, , or those that are heavily calcified, will require de-calcification and hence necessarily take longer to process before they become available to the pathologist for reporting.

Bone excisions, including exostoses and femoral heads may take up to 28 days for processing and reporting.

Cases where an infectious agent is known or suspected e.g. HIV or TB, including diagnostic biopsies, will require a minimum of 24 hours fixation in formalin before being processed.

Urgent reports If a report is required in less than the normal departmental turn around time (as indicated above), please mark the request form “Urgent” and indicate on the request form the reason for the urgency, or preferably, please call the histopathology department. You may be asked to speak directly to a consultant histopathologist to explain why the report is required urgently. Depending on the nature of the specimen, a provisional report may be issued initially as the case may require additional investigations, such as special stains or immunohistochemistry. If the specimen is small, we may be able to process it overnight and have the result (or a provisional result depending on the findings) available for the next working day (around 11 am). However, you will need to make sure that the specimen arrives in the laboratory no later than 4.30 pm on the day of the procedure. Delivering an “urgent” specimen personally to the laboratory will ensure timely receipt and avoid transport delays, as well as provide an opportunity to discuss the case directly with the pathologist. Medium or larger specimens will require overnight fixation prior to processing. In these situations, the pathologist assigned to the case will inform the requesting clinician as to the earliest time the report is likely to become available.

Frozen sections

The laboratory provides an intraoperative reporting service Monday to Friday, between 9 am – 5 pm. As far as possible, this must be booked in advance (24 hours’ notice is required) with the laboratory and discussed with a pathologist. The specimen must be sent to the laboratory fresh, without any formalin fixative.

Factors known to affect the interpretation of histology specimens

 Lack of clinical details on the request form or failure to provide relevant information, such as the patient’s previous history, including previous diagnoses, histology/ cytology results etc.  If the size of the biopsy is too small, then ancillary investigations such as immunohistochemistry may not be possible.  If a biopsy contains only necrotic tissue, then interpretation will be limited.  Delayed fixation artefact may hamper interpretation, particularly if the specimen has been sent fresh or with inadequate formalin fixative (e.g. using a container that is inappropriately small relative to the size of the specimen).

142

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 143 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

 Poor fixation may also occur if small biopsies are placed on the inside of the specimen container lid, rather than within the formalin fixative in the container.  Some disease processes are, by nature, patchy or segmental, leading to unavoidable sampling errors and “false negative” results. For example, a temporal biopsy that does not show histological evidence of arteritis does not necessarily exclude such a diagnosis in that patient.  To exclude coeliac disease, a minimum of four duodenal biopsies (from D2) is recommended.  For the confirmation or exclusion of CIN, a minimum of two colposcopically-directed cervical biopsies is recommended.  Poor orientation of small biopsies, such as upper or lower GI tract biopsies, may lead to cross cutting artefacts in the laboratory and difficulties in interpretation. For this reason, the biopsies should be correctly orientated on acetate strips before placing in formalin fixative. How do I get histology results?

Results are obtained on Sunquest ICE. However if the results are not available please ring the Histopathology office: 020 7288 5076.

POST-MORTEM EXAMINATIONS The reporting TAT for hospital (consented) post-mortem examinations (PMs), including histological investigation, is 4 weeks. PMs requiring specialist neuropathological or cardiac examinations will, however, take longer to complete. For Coroner’s PMs, which form the majority of the report TAT is variable and is dependent on the complexity of the case, particularly if toxicological examination or mineral content (e.g. asbestos fibre count) is also required. As with all reports sent out from the histopathology department, the PM reports are sent to the secretary of the named consultant, such as the surgeon or physician, and not to the ward. For ITU patients, however, a copy of the completed report will also be sent to the ITU consultant. It is not possible to make PM reports widely available on ICE due to their “sensitive” nature, as well as for other reasons, such as legal restrictions about who is able to receive Coroner’s PM reports without the authority of the Coroner. PM reports from Coroner’s cases that are proceeding to inquests are also subject to further restrictions due to subjudice. If a copy of a PM report is required from a hospital patient, please contact the histopathology office to discuss this with a pathologist, on 020 7288 5076. Reports for PMs carried out by external pathologists may only be obtained directly from the Coroner’s office at St Pancras Coroner’s Court. For contact details and further information regarding the post- mortem service, please see under the Mortuary Services section.

CYTOLOGY INVESTIGATIONS There are 2 types of cytology investigations. (1) Diagnostic cytology, also called non-gynae or general cytology and (2) Cervical cytology. CERVICAL CYTOLOGY This service is now provided by Cervical Screening London (CSL) as commissioned by NHSE/NSHI. They are responsible for the provision of supplies, transportation and result reporting. To order supplies use on line order page at https://pathologyforms.formstack.com/forms/hpv_surgery_supplies. Supplies will be delivered by Parcel Force so please allow 5 days for delivery. For queries about sample taker supplies, please contact: [email protected] or 020 7307 9440. For transportation / collections contact TDL Collect at [email protected] or via telephone on 020 7307 7373.

143

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 144 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Primary Care users:  It is expected that primary care sites are connected to tQuest for requesting and electronic return of results to their practice management system. If you have any difficulties please contact the CSL IT team at [email protected] or by phoning 020 7307 7365.  If necessary the electronic HMR101/5 form (2009 version) downloaded from the Open Exeter system can be used

Hospital users:  In most cases Colposcopy clinics and secondary referral centres will need to request using a printed HRM101 form accessed via Open Exeter.  There results will initially be emailed back via scanned pdf to a designated email. Post go live other options such as the eView portal will be offered. If you have any specific queries please contact CSL on 020 7460 4851.

DIAGNOSTIC (NON-GYNAE) CYTOLOGY

General instructions for specimen collection and handling  Standard precautions must be taken during specimen collection and handling of the sample, as with all fresh (non-fixed) biological samples.  Ensure the lids of the sample containers are correctly screwed on to minimise the risk of spillage, particularly during transport to the laboratory. Do not use adhesive tape or sticking plaster on the lids.  Samples must be sent to the laboratory as soon as possible. Samples may be stored at room temperature but if there is more than a few hours delay, samples should be stored in the refrigerator at 4C (e.g. at weekends) to minimise deterioration of the cells. It is important to adhere to the following guidance for the specific specimen types so that interpretation by the pathologist is not compromised (see below - Factors known to affect interpretation of cytology results). Specific instructions Sputum Send a deep cough specimen (taken before brushing teeth, meals and with as little salivary contamination as possible) on three successive days. This will greatly increase the sensitivity of the test. As an investigation for Pneumocystis jurovecii (carinii), a sputum specimen is virtually useless; a bronchial lavage specimen is required. Serous effusions e.g. ascitic & pleural fluids Send 20 ml (i.e., the volume of one “universal container” at least), or if less is obtained, send as much as possible, preferably a freshly aspirated specimen, rather than from a drainage jar. If the sample volume is less than the recommended amount, then ancillary investigations such as immunohistochemistry may not be possible. Urine Send a whole volume freshly voided specimen (preferably mid-morning), especially the last few drops. DO NOT send a single specimen to be shared between cytology and microbiology since the methods of urine collection are different. DO NOT send a MSU, EMU or 24 hr urine for cytology (these types of specimen are only used for microbiology and biochemistry investigations). Such specimens are considered suboptimal for cytological examination.

144

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 145 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

If the specimen is from a urinary catheter please indicate this on the request form. Endoscopic (including bronchoscopic) Brushings Brushings may be obtained from the lower respiratory tract (bronchi), oesophagus or biliary tree under direct vision at endoscopy. The brush should be firmly rolled along the mucosal surface whilst ensuring good contact with the bristles. This may produce some bleeding that can limit further endoscopy and sampling but gentle strokes of the brush are unlikely to yield diagnostic material. The obtained material should be spread thinly over the glass slide, to minimize clumping of the cellular material. The slide must then be promptly sprayed with Cytofixx spray fixative (alcohol). The cellular material must not be allowed to dry out – hence the need for prompt spraying of the fixative on to the glass slide. The cytology laboratory will provide the fixative spray on request and will also be happy to provide advice regarding fixation technique. It is recommended that at least two wet-fixed (alcohol-fixed) slides should be prepared and submitted. Endoscopic Washings Mucosal surfaces may be washed with saline to collect exfoliated cells. These are likely to be less well preserved than the cells abraded directly by a brush. Washings must be sent to the laboratory as soon as possible. If there is any delay, the sample may be refrigerated at 4C to preserve the cells and sent to the laboratory the next working day. Pre- and post-biopsy washings should be clearly labelled. Gastric and biliary tree washings should ideally be sent to the laboratory immediately for processing to prevent the rapid degeneration of cells that invariably occurs due to contamination with enzymes normally present in gastric and pancreatic juices. Fine Needle Aspiration Cytology (FNAC)  The laboratory offers a diagnostic service only; we currently do not perform the aspirations.  The best aspirates are obtained by those who undertake them on a regular basis.  Air-dried smears are preferred when aspirates are from the breast, thyroid and salivary gland.  Please ensure that the smears are either thoroughly air-dried or rapidly sprayed with Cytofixx spray fixative (alcohol). (within 1 second of spreading).  Needle washings should be submitted if the specimen obtained is particularly bloody.  For lymph node aspirates for suspected malignancy, needle washings are preferred in order to permit ancillary investigations, such as immunohistochemistry.  The Cytology lab will provide glass slides and fixative if required. Staff will also be able to provide advice on (and demonstrate if required), smear preparation techniques.  As a minimum requirement, the patient’s surname and hospital number must be clearly written with a lead pencil on the frosted section of the glass slide. Do not use a ballpoint (biro) or ink pen.

Semen Analysis The Histo/Cytopathology and Microbiology Departments provide a joint service for semen analysis. The numbers of spermatozoa, sample volume, degree of liquefaction, % motility and count are measured in Microbiology and an interim report will be issued on the same day. The sample is then passed to the Cytology department for morphological assessment of abnormal forms. A final report issued, usually up to 7 days after the sample collection date. Due to the highly specialist nature of this test, interpretation of semen analysis should be made together with other investigations. Specialist medical advice is available from Mr Gidon Libermann, Consultant Gynaecologist specialising in Reproductive Medicine & Surgery in the Fertility section of Womens’ Health (see above).

145

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 146 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Reference Values (morphology only) The lower reference limit for abnormal forms is 96% (World Health Organisation Laboratory Manual for the Examination and Processing of Human Semen, 5th Edition, 2010, p.100). Factors known to affect the interpretation of semen samples for morphology  Lack of clinical details supplied  Degenerative changes may affect the interpretation  Screw lid not secured properly resulting in sample leakage.  All BMSs taking part in the interpretation of semen analysis are fully trained and competent and also take part in the UK NEQAS Reproductive science scheme. Due to the subjectivity of the interpretation by different BMSs. The measurement uncertainty due to variation in interpretation has been calculated as 0.16%

Factors known to affect the interpretation of cytology samples  Lack of clinical details on the request form or failure to provide relevant information, such as the patient’s previous history, including previous diagnoses, histology/ cytology results etc.  If the sample volume (e.g. serous fluids) is less than the recommended amount, then ancillary investigations such as immunohistochemistry may not be possible.  When a collected sample has been left at room temperature for more than 24-48 hours, particularly urine samples, this may not only lead to an overgrowth of bacteria or yeasts, but this may also result in deterioration of the cells within the sample (degenerative cellular changes). These factors could result in the sample being reported as unsatisfactory.  Degenerative cellular changes may also hamper interpretation if the sample has been obtained from the drainage jar (serous fluids) due to deterioration, or if an early morning urine is submitted for cytological investigation, rather than a mid-morning urine sample.  Heavily blood-filled samples, including smears from FNA aspirates may result in staining artefacts and obscuring of the morphological details of individual cells.  When only occasional or scanty malignant cells are present e.g., within a large volume serous effusion, or in urine samples, this may lead to “false negative” results.  If there is delayed air-drying or fixing in alcohol of prepared smears, this may result in morphological artefacts leading to difficulties in interpretation of the nature of the cellular changes seen in brushings specimens (e.g., bronchial, oesophageal or bile duct), or fine needle aspirates (breast, lymph nodes etc).  Interpretation difficulties may be encountered when samples obtained during the above procedures are either poorly spread with clumping of the cells, or mixed with a large amount of blood.  Ultrasound gel or glove powder may contaminate a sample (particularly FNA smears) or crystals, such as uric acid, in urine samples and obscure cellular material, giving rise to difficulties in interpretation and an unsatisfactory or non-diagnostic result.  A heavily purulent sample or sampling of only necrotic tissue may lead to an unsatisfactory or non- diagnostic result. Request forms For Diagnostic (non-gynae) cytology samples: Hospital users: Please use Sunquest ICE electronic request forms. Printed hospital combined Microbiology/Histology/Cytology request forms can, however, still be obtained from the Histopathology department for a limited period (please call x5072).

146

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 147 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Primary Care users: Please use the printed GP combined Microbiology/ Histology/ Cytology request forms (call 020 7288 5754 to obtain a supply). These have been recently updated to accommodate the patient’s NHS number. How do I get cytology results? Diagnostic (non-gynae) cytology only results are available on Sunquest ICE. If the results are not available please ring the following telephone numbers:- For Diagnostic (non-gynae) cytology: 020 7288 5076 For Semen analysis: 020 7288 5088 (Microbiology Department)

When will the result be available?

As with histopathology specimens, the cytology laboratory is highly conscious about the need to turn around specimens in the shortest time possible without, however, compromising diagnostic accuracy and patient safety. Turnaround times (TAT) are closely monitored by the laboratory management on a regular basis and this information is available to service users if required.

All general cytology samples will be reported as soon as possible and timely delivery to the laboratory is, therefore, essential to minimise any delay in the preparation and reporting of the sample by the cytopathologist.

The laboratory aims to report all samples within 7 calendar days (or 5 working days), as agreed with the various clinical teams (Recommended reporting TAT standard: 80% in 7 calendar days or 5 working days of the sample collection procedure).

Depending on the type of sample, a provisional report may be issued initially by the cytopathologist, as the case may require ancillary investigations, such as special stains or immunohistochemistry. A further report will be issued on completion of these additional investigations.

Urgent reports If a report is required in less than the normal departmental turn around time (as indicated above), please mark the request form “Urgent” and indicate on the request form the reason for the urgency, or preferably, please call the cytology department. You may be asked to speak directly to a consultant to explain why the report is required urgently. If the specimen is already prepared on receipt in the laboratory (e.g direct smears from a FNA or a brushings sample), we will aim to stain and report the sample on the same day, providing this reaches the laboratory by 4 pm. If the sample is received after 4 pm, however, then this will be stained on the morning of the next working day and the result (or a provisional result depending on the findings) will be available by 11 am. Delivering an “urgent” specimen personally to the laboratory will ensure timely receipt and avoid transport delays, as well as provide an opportunity to discuss the case directly with the pathologist.

147

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 148 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

MORTUARY SERVICES

The mortuary at the Whittington serves both as a hospital mortuary as well as a public mortuary for the London Borough of Islington. Opening times: Mortuary : 8.00am to 4.00p.m. Monday to Friday Telephone numbers: Mortuary: 020-7288-5330/3119 Access: The mortuary can be accessed via the hospital’s service road entrance, off Dartmouth Park Hill.

MEDICAL CERTIFICATES OF CAUSE OF DEATH (MCCD)

A Medical Certificate of Cause of Death (MCCD) should be completed by a clinician who has been in attendance to the deceased within 14 days prior to the death. All criteria for the legal completion of an MCCD shall be met before it is issued (see below) In England and Wales a doctor can only certify a death without reference to the Coroner if: 1. He/She has been in clinical attendance during the last illness and has seen the patient during the 14 days prior to the death. 2. He/She can issue an MCCD with a legally recognised cause of death to the best of their knowledge and belief. 3. He/She must be satisfied that the death is wholly due to natural causes and that no unnatural event has contributed. NOTE: It is an illegal act for a doctor who has never treated the deceased to issue a Medical Certificate of Cause of Death no matter how much pressure is applied by any persons including both the family and senior clinicians. Death Notifications: At the time of completing an MCCD, the doctor will also complete a ‘Deceased Patient’ letter on Sunquest ICE. The letter will be e-mailed directly to the corresponding General Practitioner using a secure e-mail address. A hard copy will be filed within the casenotes.

CAUSE OF DEATH STATEMENT

Part I

 State the disease or condition directly leading to death on the first line (Part Ia).

 Complete the sequence of disease (s) or condition(s) leading to death on subsequent lines.

 State the Underlying Cause of Death on the last completed line of Part I.

148

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 149 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

 The disease or condition directly leading to death and the Underlying Cause of Death may be the same. In this case, you only need to complete the first line of Part I.

Part II

 If there is some significant condition or disease that contributed to the death but which is not part of any sequence leading directly to death, you should record it in Part II, e.g. diabetes mellitus that is difficult to control in a patient with widely disseminated malignancy.

TERMS WHICH IMPLY A MODE OF DYING, RATHER THAN A CAUSE OF DEATH AND SHOULD POSSIBLY BE AVOIDED ON “DEATH CERTIFICATES” UNLESS ACCOMPANIED BY THE UNDERLYING CONDITION OR DISEASE CAUSING IT.

Asphyxia Cardiac arrest

Cardiorespiratory arrest Cardiac failure

Coma Debility

Exhaustion Heart failure

Hepatic failure Hepatorenal failure

Kidney failure Liver failure

Renal failure Respiratory arrest

Respiratory failure Shock

Syncope Uraemia

Vagal inhibition Vasovagal attack

Ventricular failure Weakness

ISSUING A MEDICAL CERTIFICATE OF CAUSE OF DEATH (MCCD) ‘OUT OF HOURS’ BACKGROUND On occasion and usually due to the religious mores of certain ethnic groups, the family of the deceased may be anxious to register the death as soon as possible following the death. Frequently, these same groups will wish to take the body to their place of worship for ritual purification and washing prior to disposal. It is the Trust's desire to accede to these wishes in so far as is legal and practicable. The following arrangements apply for the issuing of an MCCD and the release of a body from the mortuary, ‘out-of-hours’. N.B. No deviation from these arrangements will be allowed. LB Islington Register Office

149

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 150 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

The office of the Registrar for Births, Deaths and Marriages in the London Borough of Islington is open ONLY between the following times - 09:30 - 16:00 from Monday to Friday 10:00 - 12:00 on Saturday for timed appointments ONLY

An emergency standby service is available on Sunday mornings between 09:30 and 11:00 hours.

ROLE OF THE MORTUARY STAFF The Mortuary staff make every effort to accommodate the wishes and religious mores of minority groups. However, they are constrained within the Laws of the Realm and the vagaries of the LB of Islington Register office. Being mindful of the sensitivity of this issue, the Duty Mortuary technician will attend the hospital ‘Out-of-Hours’ to issue a ‘Medical Certificate for Cause of Death’(MCCD) if all necessary requirements are met (see Appendix II). They will give assistance to next of kin in making an appointment to register a death at weekends between the hours stated above. The duty Mortuary technician will attend the hospital (contact via switchboard) to issue an MCCD only:  Where the death does not fall under the jurisdiction of H.M Coroner (see Reporting deaths to H.M.Coroner)  Where the death occurs between 16:00 hours Friday to 09:00 hours Sunday - this will allow the death to be registered at the LB Islington Register Office between 10:00 and 12:00 on Saturday and 09:30 and 11:00 on Sunday in an emergency.  Where the doctor who has been in attendance (treated the patient within the previous 14 days) to the deceased during the final illness is available to complete a Medical Certificate with a legally recognised cause of death to the best of their knowledge and belief.  At ALL other times an MCCD, if appropriate, will be issued as soon as possible on the first working day following the death. Do not call-out the Duty Mortuary APT (Anatomical Pathology Technologist) at unreasonable hours. APPROPRIATE SIGNATURE ON DEATH CERTFICATES It is the responsibility of the medical officer directly involved in the management of the patient immediately prior to death to complete the ‘Medical Certificate for Cause of Death’. NB: the Registrar of Deaths will automatically report the death to the Coroner if the MCCD has been issued by a doctor who has not attended the deceased within 14 days prior to death.

REPORTING DEATHS TO H.M. CORONER ROLE OF THE CORONER The Coroner is an independent judicial officer of the Crown who has a statutory duty to investigate the circumstances of certain categories of death for the protection of the public. Legal aspects As the law currently stands, there is no statutory obligation for a doctor to report any death to a Coroner. The common law duty that requires any person to inform the Coroner of circumstances requiring an inquest cannot be enforced by legal sanction. Nevertheless, doctors are encouraged to voluntarily report all relevant deaths (see below) to the Coroner. Ms Mary Hassell was appointed H.M. Coroner for Inner London North on July 7th 2013 and has, in preparation for the proposed Medical Examiner system, introduced a referral form throughout the jurisdiction. The referral form must be used for all deaths within the hospital that meet the criteria for a Coroner’s investigation or where advice and guidance may be required by the clinicians as to whether an MCCD can be issued. Note: It is now no longer possible to talk directly to a Coroner’s Officer in relation to a death as all decisions are now solely the remit of H.M. Coroner or one of her deputies. A decision will be made

150

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 151 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021 based on the information on each referral form and any further information that H.M. Coroner Hassell requests.

How should it be done? The referral form is only available, at present, on the mortuary I drive and must be completed electronically. During working hours a clinician can complete the form by either attending the mortuary or asking for the form to be mailed directly to them. ‘Out of Hours’ the form can be made available by contacting the duty mortuary technician via switchboard. When completed the referral form must be mailed back to the mortuary manager or his deputy who will in turn email the document to a secure generic address for all Coroner’s Officers based at St Pancras Coroner’s Court. The referral will be actioned by a designated Coroner’s Officer who will present the case to H.M.C and await a decision before responding to the referring clinician unless further information is required. Criminal or suspicious deaths should be reported immediately whatever the time of day.  If you are in doubt about whether to report a death, you may contact the mortuary manager or his deputy for informal advice. ‘Out of hours’ this will be via switchboard.  Until recently it has been local practice for clinicians to refer deaths to the Coroner if they occurred within 24 hours of admission to hospital. This is now no longer required. If there is sufficient clinical or supporting evidence that ‘natural causes’ were responsible for the death, despite the duration of the illness and no unnatural indicators are present, a registered medical practitioner may issue an MCCD without referral to the Coroner.  In cases of medical interest, on no account should a death be reported to the Coroner for the sole purpose of obtaining a post-mortem. It is not uncommon for a clinician to be able to issue a legitimate cause of death ‘on the balance of probabilities’ but feel a further investigation may be valuable in determining whether any possible contributing disease processes are present. In such cases, consent should be requested from the next of kin to carry out a hospital (clinical) post mortem. The mortuary staff can advise on the process for requesting a hospital post mortem. A clinician must not threaten relatives with referral of a death to the Coroner if they know or suspect that they have refused (or will refuse) permission for a “hospital” post-mortem. A Coroner’s post-mortem is limited to establishing the cause of death and may NOT therefore necessarily provide all the information that may be otherwise obtained from a consented hospital post- mortem. Note: If the certifying clinician was not in attendance to the deceased within 14 days prior to the death the MCCD will be ‘bounced’ to H.M. Coroner by the Registrar of Deaths which may ultimately delay the funeral and cause further distress to the family.

Important Telephone Numbers

St. Pancras Coroner’s Court (open 8am – 3.30pm, Monday to Friday): Camley Street, London NW1

020 7974 4545

After hours and at weekends or Bank holidays, the on-call Coroner’s officer may be contacted by:

Dialling: 101 and asking to be put through to the on call Coroner’s officer for Inner London North or via

151

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 152 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Holloway police 020 - 7263 9090 Islington Control Room 020 - 7421 0284

Note: The duty mortuary technician is available, via switchboard, if there are any problems contacting a Coroner’s Officer

For any immediate help during working hours, contact:

Mortuary Office Ext. 5330/3119 Mortuary Manager Ext. 5696

Deaths are reportable to the Coroner when:

 The cause of death is sudden, unnatural or unexpected.  The cause of death is not known or uncertain.  There is any element of suspicious circumstances or history of violence.  The death may be linked to an accident (whenever it occurred).  The death may be due to industrial disease or related in any way to the deceased’s occupation.  The death is linked to an abortion.  The death occurred during an operation or before full recovery from the effects of anaesthesia, or, was in any way related to the anaesthesia.**  The death may be related to a medical (or dental) procedure or treatment.  The actions of the deceased may have contributed to his or her own death (e.g., self neglect, drug or solvent abuse).  The death occurred in police or prison custody (includes a death from an illness or injury which occurred during detention).  The deceased was detained under the Mental Health Act.

** Normally 48 hours.

CREMATION FORMS

Further documentation is required for a cremation to take place. Cremation Form 4 is normally completed by the doctor that completes the MCCD. It may either be the G.P. or a junior hospital doctor. This doctor MUST see the dead body (he/she does not legally have to see the body in order to issue a Medical Certificate, although this is highly advisable). Cremation Form 5 is the confirmatory medical certificate and is completed by a doctor who has been fully registered for at least 5 years. The doctor must not be related to the first doctor nor to the deceased. This doctor should not be in the same general practice as the first doctor or in the case of a hospital death, should not be on the same medical team. Where a post-mortem examination has been held (other than a Coroner’s post-mortem), it is usually the pathologist who completes cremation Form 5 unless Cremation form 4 is completed subsequent to the post mortem whereby the Confirmatory Certificate 5 is not required. The doctor completing Form 5 will need to speak to both the doctor completing Form 4 and another person who has been in attendance to the deceased during the final illness. Cremation Form 6 is the Coroner’s Certificate for cremation which is issued to the nominated funeral director by H.M Coroner

152

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 153 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

POST-MORTEMS

Post-mortem examinations are carried out in a modern autopsy suite with viewing facilities. Post mortems are of two types. (I) Those performed for clinical interest on patients dying in hospital. This requires consent from the relatives of the deceased. (II) Those performed at the request of the Coroner for whatever reason, either on patients dying in hospital (or certified dead on arrival at hospital) or, on individuals dying outside the hospital (within the Borough of Islington).

POST-MORTEM REPORTS:

Clinical Interest post-mortems: A copy of the report is sent to the family and responsible consultant clinician within six weeks of the examination. However, if the G.P. requires a copy, this can be arranged by contacting the Histopathology department on 020-7288-5076. Coroner’s post-mortems: The post-mortem report is the property of H.M. Coroner. However, with the Coroner’s authorisation, a copy of the report will be normally sent to the Consultant in the case of hospital deaths (providing the post-mortem has been performed by one of the hospital pathologists). Further copies, however, may only be obtained from the Coroner (St .Pancras Coroner’s Court; Telephone: 020-7974 -4545).

REQUESTING HOSPITAL POST-MORTEMS

Doctors at all grades are encouraged to request post-mortem examinations in cases of hospital deaths. They should then endeavour to attend the autopsy, where the pathologist will present the findings to them. In cases not reportable to the Coroner, consent (preferably written) for post-mortem examination must be obtained in accordance with the procedures documented in the Trust consent policy (Policy for the consent to post mortem examination and the retention of tissue). When written consent is obtained this should be documented on the Trust post mortem consent form, copies of which are available in the mortuary. To avoid any distress and embarrassment to relatives, the following should be noted:  There should not be any undue pressure placed on relatives, nor any threats made (such as referral to the Coroner) in order to obtain consent.  Consent for post-mortem (PM) should not be sought if the cause of death is unknown and/or the death is being reported to the Coroner, unless the Coroner wishes to take no further action and instructs the clinician to issue the Medical Certificate for Cause of Death.  If the next-of-kin refuses consent for a hospital post-mortem, on no account should the case be then referred to the Coroner (with a view to obtaining a post-mortem). N.B: A Coroner’s post-mortem is limited to establishing the cause of death and may NOT therefore necessarily provide all the information that may be otherwise obtained from a consented hospital post mortem If satisfactory personal contact has been established with the next-of-kin prior to the death of the patient and, if a request for a post-mortem is made soon after the death, unnecessary distress could be avoided. Advice for the requesting clinician 1. Although the patient’s hospital notes will be available to the pathologist performing the autopsy, you will be required to fill in a post-mortem request form, providing details of the clinical history and specific questions that the medical team would like investigated during the examination. Alternatively, you can contact the relevant pathologist directly to discuss the case prior to the post- mortem. Mortuary staff will be able to advise you as to which pathologist to contact. 2. If you are going to be unavailable (for whatever reason) to speak to the relatives directly to seek consent for post-mortem, the mortuary manager or a nominated deputy will be happy to do this on your behalf.

153

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 154 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

3. The post-mortem will be performed by a hospital pathologist usually on the next working day after consent has been obtained. The funeral arrangements will therefore not be delayed (it is important for relatives to be assured of this). 4. You are encouraged to attend the post-mortem when the findings will be presented to you. The mortuary staff can inform you of the date and time of the post-mortem. 5. If you are unable to attend the post-mortem you are strongly encouraged to contact the pathologist after the post-mortem, who will be happy to discuss the findings with you. A copy of the full post- mortem report will be sent to the Consultant(s) who attended to the patient at the time of his/her death within six weeks of the examination.

Important telephone numbers

Histopathology Mortuary

Consultants: Dr Su Ramachandra Ext. 5074 Mortuary office Ext. 5330/3119 Mortuary manager Ext. 5696

Specialist Registrar Ext. 5073

Office (For PM Reports) Ext. 5076

154

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 155 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

MORTUARY APPENDIX I

WHY ARE POST-MORTEM EXAMINATIONS (AUTOPSIES) PERFORMED?

Apart from establishing the cause of death, the post-mortem examination has many uses. These include:  To assess the accuracy of clinical diagnosis.  To assist in the audit of clinical care.  To enhance the accuracy of death certification.  To improve the quality of the Registrar General’s cause of death statistics, with implications for national health policy.  To assist in medical undergraduate training.  To assist in general postgraduate medical and surgical training.  To assist in the training of pathologists.  To advance medical research in the clinical, pathological and basic medical sciences.  To validate and monitor new and established diagnostic procedures.  To monitor the effectiveness and side effects of new medical and surgical therapies.  To assist in counselling the bereaved, especially the parents of children who are stillborn, or dying of conditions which may have a genetic basis.  To identify genetically determined conditions which may affect relatives of the deceased, who could then be identified by family screening and offered early diagnosis and treatment for pre- symptomatic disease.

155

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 156 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

MORTUARY APPENDIX II

ISSUING MEDICAL CERTIFICATES FOR CAUSE OF DEATH (MCCD) ‘OUT-OF HOURS’

CHECK LIST 1. Medical Certificates for Cause of Death will be issued out-of-hours ONLY where death occurs between 16:00 hours Friday to 09:00 hours Sunday. 2. MCCDs can be issued only if the cause of death does NOT fall under H.M. Coroner's jurisdiction. 3. The appropriate medical officer MUST be available to sign the MCCD as soon as it is prepared by the Duty Mortuary technician. 4. The Duty Mortuary technician is available (via switchboard) to issue an MCCD only if ALL the above criteria can be met. 5. L B Islington Register office is open: 09:30 - 16:00 from Monday to Friday 10:00 - 12:00 on Saturday for timed appointments only 09.30 – 11.00 on Sunday mornings in emergency only

6. Unrealistic promises should not be made to bereaved relatives about the completion of an MCCD as this will only cause further distress. 7. If the death has been registered and the relatives are pressing for the release of a body out-of- hours it is the responsibility of the Duty Site Manager to oversee removal of the deceased. This requires production of the 'Green Disposal Form' from either the family or the funeral director. Without the 'Green Disposal Form’ the body may NOT be released under any circumstances. The Duty Mortuary technician can be contacted (via switchboard) for any advice on the above

156

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 157 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

ADULT BD BLOOD TUBE GUIDE

157

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 158 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

PAEDIATRIC BLOOD SAMPLE COLLECTION GUIDE

Standard (BD vacutainer blood tubes) should be used whenever possible for children aged over 2 years. When samples are taken in the paediatric (Sarstedt) tubes there is a risk the sample will be insufficient for analysis and tests will have to be repeated.

Special collection Test requested Paediatric collection Standard collection conditions

White - 25 OH Vitamin D Gel Serum Serum

White - 17 OH Progesterone Gel Serum Serum

Place 4 blood spots on a Blood spot on Guthrie Guthrie card, label fully Acyl carnitine with patients details and card send ASAP to Blood Sciences

Sample must be Red – received by lab within 10 Ammonia EDTA EDTA minutes of venepuncture.

Antibiotic / White - Anticonvulsant Gel Serum Serum Levels

White - B12, Folate & Ferritin Gel Serum Serum

Biochemistry - U&Es, Orange – LFTs, bone, CRP, Lithium Gel Serum

amylase, CK Heparin

0.5 – 5mL of blood Blood Cultures BD Blood culture bottle required

158

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 159 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Special collection Test requested Paediatric collection Standard collection conditions

Fungal bottles are Blood Cultures – Fungal blood culture available from microbiology. Fungal bottle 8 – 10mL of blood required

TB bottles are available from microbiology. Blood Cultures – TB TB blood culture bottle 1 – 5mL of blood required

Green – Coagulation Sodium Sodium Citrate Citrate

White - Cortisol Gel Serum Serum

ESR Adult BD tube required EDTA

Red – FBC EDTA EDTA

Yellow – Fluoride Glucose Fluoride Oxalate

EDTA for Red – Blood Group & save EDTA Crossmatch Transfusion

< 4 months > 4 months

Haemoglobinopathy Red – EDTA screen (HPLC) EDTA

White - No additive Immunology Serum Plain Serum

Orange – Sample must be Lithium received by lab within 10 Insulin Lithium Heparin minutes of Heparin venepuncture.

159

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 160 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Special collection Test requested Paediatric collection Standard collection conditions

Insulin like growth White - Gel Serum factor1(IGF1) Serum

Sample must be Yellow – Fluoride Lactate received by lab within 10 Fluoride Oxalate minutes of venepuncture.

Orange – Lithium Plasma amino acids Lithium Heparin

Heparin

Trace Element tube Trace element - Tubes can be obtained (lavender band) - Chromium & Cobalt from biochemistry. EDTA Trace element - Trace Element tube Tubes can be obtained Copper, Zinc, & (red band) - Serum from biochemistry. Selenium

White - Thyroid Function Gel Serum Serum

Urine amino acids Plain sterile universal Sample must be taken Urine organic acids container to Blood Sciences ASAP

Sample must be Orange – Very Long Chain Lithium received by lab within 10 Lithium minutes of Fatty Acids Heparin venepuncture. Fasting Heparin sample preferred.

Red – Viral loads EDTA EDTA

White - No additive Virology Serum Plain Serum

Order of Draw - Paediatric Collections - Sarstedt Order to Draw - Standard Collections - BD 1. White Serum 1. Light Blue Sodium citrate 2. Green Sodium Citrate 2. Red Plain serum 3. Orange Lithium Heparin 3. Gold Gel serum 4. Red EDTA 4. Green Lithium heparin

160

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 161 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

5. Yellow Sodium Fluoride 5. Lavender EDTA 6. Pink EDTA – Blood Transfusion 8. Royal Blue Trace Elements 7. Grey Fluoride Oxalate

Adult BD Blood Sample Collection Guide

Order of Draw

Mix by Collection Tube Volume Colour Inverting 1 Blood culture bottle 8 mL Culture Bottles 8 - 10 times 2 Light Blue – Sodium Citrate 2.7 mL B 3 - 4 times 3 Red – Plain Serum - No additive 6 mL R 5 - 6 times 4 Gold SST Gel – Gel Serum Clot activator 5 mL G 6 - 8 times 5 Green – Lithium Heparin Tube 4 mL Gn 8 - 10 times 6 Green – Lithium Heparin Tube 6 mL Gn 8 - 10 times 7 Lavender - EDTA Tube 4 mL L 8 - 10 times 8 Pink Top – EDTA for Blood Bank 6 mL Pk 8 - 10 times 9 Royal blue with red band on label 6 mL DR 5 - 6 times 10 Royal blue with lavender band on label 6 mL DL 5 - 6 times 11 Grey - Fluoride Oxalate tube 2 mL Gr 8 - 10 times

β Blood Tubes Collection Instruction

α-1 Antitrypsin G

α-Fetoprotein G

Discuss with Biochemistry before sample collection. β Carotene G Protect from light and straight to Lab

β-2-Microglobulin G Discuss with biochemistry before sample collection

βHCG G

Discuss with biochemistry before sample collection - β-Hydroxybutyrate Gr Straight to lab without delay

0-9 Blood Tubes Collection Instruction

161

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 162 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Discuss with biochemistry before sample collection - 1,25 dihydroxy vitamin D G Straight to lab without delay

17 OH Progesterone (serum) R

25 OH Cholecalciferol G

A Blood Tubes Collection Instruction

ABG Heparinised blood gas syringe. Take to lab without delay

ACE G

Acetyl Choline Receptor R Antibodies

Acid - Base status Heparinised blood gas syringe. Take to lab without delay

Discuss with Biochemistry before sample collection - ACTH L Straight to lab without delay Activated partial thromboplastin B time

Actual bicarbonate G

Acute Leukaemia Panel L L Discuss with Haematology before sample collection

Acyl Carnitine Blood spot on Guthrie card

Adenovirus R

Adrenal antibody R

AFP G

Alanine Aminotransferase (ALT) G

Albumin G

Alcohol Gr

Aldosterone L Straight to lab without delay

Alkaline Phosphatase (ALP) G

Alkaline Phosphate isoenzymes G

Allergen specific IgE R

Allergy Test R

Alpha Fetoprotein G

162

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 163 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Alpha-1 Antitrypsin G

AMA (Anti-mitochondrial R Antibodies)

Amikacin R Indicate date and time of last dose on request form

Discuss with Biochemistry before sample collection - Amino Acids Gn Straight to lab without delay

Aminophylline G Indicate date and time of last dose on request form

Aminotransferase (AST) G

Discuss with Biochemistry before sample collection - Ammonia L Straight to lab without delay

Amphiphysin G

Amylase G

ANA R

ANCA R

Androgen Screen G

Androstenedione R

Angiotensin Converting Enzyme G

Antenatal Serology R

Anti C1q R

Anti Cardiolipin R

Anti GAD R

Anti GBM R

Anti LKM R

Not Routinely Available - Patient must be referred to clinic Anti Mullerian Hormone (AMH) G 4C

Anti-Basal Ganglia Abs R

Antibody titre R

Anti-CCP R Anticoagulant Control - Heparin control; Oral Anticoagulant Control B (INR)

163

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 164 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Anticonvulsant Drugs G Indicate date and time of last dose on request form

Anti-cyclic citrullinated peptide R (CCP) Anti-HCV antibody screen and R confirmation

Anti-Hepatitis Bs antibody R

Anti-HIV 1 and 2 antibody and p24 R antigen screen

Antineuronal Antibodies (Yo/Hu/Ri) R

Anti-neutrophil cytoplasmic R antibody (ANCA) Antinuclear antibody (ANA), R includes anti-centromere

Antistreptolysin O Screen R

Antithrombin B Discuss with Haematology before sample collection

Anti-Tissue Transglutaminase IgA R

Anti Xa B Discuss with Haematology before sample collection

APTT B

Arterial blood gas See ABG

ASO Titre R

Aspartate Aminotransferase (AST) G

Aspergillus fumigatus precipitins R (specific IgG)

Aspergillus PCR L

Astrovirus PCR L

Auto Antibodies R

Avian precipitins (specific IgG) R

B Blood Tubes Collection Instruction

B12 G

B12 & Folate G

B2 Microglobulin G Discuss with biochemistry before sample collection Discuss with laboratory before sample collection - Straight B6 Level L to lab

164

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 165 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Bartonella R

BCR/ABL Pk Pk Discuss with Haematology before sample collection

Beta 2 Glycoprotein (IgG and IgM) G

Discuss with Biochemistry before sample collection. Beta Carotene G Protect from light and straight to Lab

Beta HCG G

Beta Hydroxybutyrate (BHB) Gr Not routinely available - Discuss with Biochemistry

Bicarbonate G

Bile Acids G

Bilirubin (conjugated/direct) G

Bilirubin (total) G

BK virus PCR L

Blood cultures Bacteriology Special collection tube available from Microbiology

Blood Film L

Blood group Pk

BNP (N-terminal pro BNP) G

Bocavirus PCR L

Bone Profile G

Bordetella pertussis serology R

Bordetella pertussis PCR L

Brucella serology R

C Blood Tubes Collection Instruction

C1 esterase R

C1 esterase inhibitor R

C3 G

C4 G

165

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 166 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Ca 125 G

Ca 153 G

Ca 199 G

Caeruloplasmin G Discuss with biochemistry before sample collection

Caffeine R Discuss with biochemistry before sample collection

Discuss with Biochemistry before sample collection - Calcitonin Gn Straight to lab without delay

Calcium G

Calcium voltage gated channels R (VGCC)

Calcium ionized G

Campylobacter serology R cANCA R

Candida precipitins R

Carbamazepine G Indicate date and time of last dose on request form

Discuss with biochemistry before sample collection - Carboxyhaemoglobin Gn Straight to lab without delay

Cardiac Enzymes G

Cardiac muscle antibodies R

Cardiolipin (IgG and IgM) R antibodies Discuss with Biochemistry before sample collection. Carotene G Protect from light and straight to Lab Discuss with laboratory before sample collection - Straight Catecholamines Gn to lab

CBC L

CCP R

CD34 (Stem cells) L Discuss with Haematology before sample collection

CD4 count (T helper cell count) L Discuss with Haematology before sample collection

CD8 L Discuss with Haematology before sample collection

CEA (carcino embryonic antigen) G

Centromere antibody (refer to ANA R panel)

166

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 167 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Chlamydia trachomatis R antibody Serology

Chloride G

Cholesterol G Indicate patient fasting status on request form

Chromium DL Royal blue with Lavender band on label

CD2, CD3, CD4, CD5, CD8, CD10, CD11c, CD16/CD56, Chronic lymphocytic L L CD19, CD23, CD25, CD38, CD79b, FMC7 - Discuss with malignancies/lymphoma panel Haematology before sample collection

Citrated Platelets B Discuss with Haematology before sample collection

CK MB G

CK Muscle G

Clauss Fibrinogen B

Clotting Studies B

CMV (cytomegalovirus) IgG R

CMV (cytomegalovirus) IgG avidity R

CMV (cytomegalovirus) IgM R

CMV (cytomegalovirus) viral load L

Coagulation B APTT; Prothrombin time; FDP D-Dimers; Fibrinogen

Factor II assay; Factor V assay; Factor VII assay; Factor VIII assay; Factor IX assay; Factor X assay; Factor XI assay; Factor XII assay; Factor VIII inhibitors; Factor IX Coagulation Factor Assays B B B inhibitors; von Willebrand factor activity; von Willebrand factor multimers; von Willebrand factor - Discuss with Haematology before sample collection

Coagulation Screen B

Cobalt DL Royal blue with Lavender band on label

Coeliac Screen R

Cold Agglutinins Discuss with Haematology before sample collection

Complement C3 G

Complement C4 G

Conjugated Bilirubin G

167

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 168 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Coombs Test (DAT) Pk

Copper DR Royal blue with Red band on label

Cortisol G

Discuss with laboratory before sample collection - Straight C-peptide Gn to lab

C-reactive protein (CRP) G

Creatine Kinase (CK) G

Creatinine G

Crithidia antibodies R

Cross matching Pk 2 samples required, taken 30 minutes apart

CRP G

Discuss with Biochemistry before sample collection - Cryoglobulins R R Pk Pk Straight to lab without delay. Sample must be collected and transported at 37oC

Cryptococcus antigen R

Cyclic citrullinated peptide (CCP) R antibodies Pre-dose sample - Indicate date and time of last dose on Cyclosporin L request form

Cystatin C G

Cytomegalovirus (CMV) IgG R

Cytomegalovirus (CMV) IgG R avidity

Cytomegalovirus (CMV) IgM R

Cytomegalovirus viral load L

D Blood Tubes Collection Instruction

D-Dimer B Discuss with Haematology before sample collection

DHEA - sulphate R

Digoxin G Indicate date and time of last dose on request form

Diphtheria IgG antibody R

Direct Antiglobulin Test Pk

168

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 169 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

DNA Testing for the L Haemoglobinopathies Double-stranded DNA antibodies R (IgG)

E Blood Tubes Collection Instruction

EBV (EBNA) R

EBV (Epstein Barr Virus) viral load L

EBV VCA IgG - screening R

EBV VCA IgM - screening R eGFR G

ENA antibodies R

Endomysial Antibody (TTG) R

Enteric Virus Panel R

Enterovirus and parechovirus PCR L

Epilim (Na Valporate) G Indicate date and time of last dose on request form

EPO G

Epstein Barr Virus (EBNA) R confirmation Epstein Barr Virus (EBV) IgG - R screening Epstein Barr Virus (EBV) IgM - R screening

Epstein Barr Virus viral load L

Erythrocyte Sedimentation Rate L Requires full sample tube (ESR)

Erythropoietin G

ESR L Requires full sample tube

Ethanol (Alcohol) Gr

Ethosuximide G

F Blood Tubes Collection Instruction

169

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 170 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Factor II assay B Discuss with Haematology before sample collection

Factor IX assay B Discuss with Haematology before sample collection

Factor IX inhibitors B Discuss with Haematology before sample collection

Factor V assay B Discuss with Haematology before sample collection

Factor V Leiden Mutation screen L Discuss with Haematology before sample collection

Factor VII assay B Discuss with Haematology before sample collection

Factor VIII assay B Discuss with Haematology before sample collection

Factor VIII inhibitors B Discuss with Haematology before sample collection

Factor X assay B Discuss with Haematology before sample collection

Factor XI assay B Discuss with Haematology before sample collection

Factor XII assay B Discuss with Haematology before sample collection

Farmer's lung precipitins (specific R IgG)

FBC L

FDP D-Dimers B Discuss with Haematology before sample collection

Ferritin G

Fibrin Degradation Products B

Fibrinogen B

Folate (Folic acid) G

Follicle stimulating hormone (FSH) G Indicate day of menstrual cycle on request form

Discuss with Haematology before sample collection - Fragile X L Straight to lab without delay Discuss with biochemistry before sample collection - Free fatty acids Gr Straight to lab without delay

Free Light Chains G

Free T3 G

Free T4 G

Fructosamine G

FSH G Indicate day of menstrual cycle on request form

170

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 171 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Full blood count (FBC) L

G Blood Tubes Collection Instruction

G6PD Screen L

Galactomannan R

Gamma glutamyl transferase G (Gamma GT) Must be a 6ml sample tube, filled to the top and hand Gamma Interferon release assay Gn delivered to serology by 15:30 on the day of sample for TB (Quantiferon) collection.

Ganglioside Abs GM1 R

Ganglioside Abs GQ1b R

Gastric Parietal Cells antibodies R (GPC) Discuss with Biochemistry before sample collection - Gastrin Pk Pk Straight to lab without delay

GBM Antibodies R

Gentamicin R Indicate date and time of last dose on request form

GGT G

Glandular fever screening test L

Glomerular basement membrane R antibodies The time of each sample must be clearly recorded on the Glucose Tolerance Test Gr Gr Gr blood tube - Patient to arrange appointment with diabetic clinic on 0207 288 5511

Glucose Gr Indicate patient fasting status on request form

Glutamic Acid Decarboxylase R (GAD) antibodies

Glycated Haemoglobin (HbA1c) L Must be a separate tube to FBC

Glycogen storage disease R enzymology

Gonadotrophins (LH/ FSH) G Indicate day of menstrual cycle on request form

Group and Screen Pk 2 samples required, taken 30 minutes apart

Growth Hormone G

171

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 172 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Discuss with biochemistry before sample collection - Gut Hormone Pk Pk Straight to lab without delay

H Blood Tubes Collection Instruction

Haemoglobin L

HbA1c L Must be a separate tube to FBC

Haemoglobin A1c L Must be a separate tube to FBC

Haematinics G

Haemochromatosis C282Y, H63D Pk and S65C genotyping Haemoglobinopathy Alpha - and beta-thalassaemia mutation L Discuss with Haematology before sample collection identification Haemoglobinopathy Screening - L Routine

Haemophilia Screen B B B Discuss with Haematology before sample collection

Haemophilus influenze PCR L

Ham's Test Pk Discuss with Haematology before sample collection

Haptoglobin G

HCG blood (pregnancy and as G tumour marker)

HDL Cholesterol G Indicate patient fasting status on request form

HDL/ LDL Cholesterol G Indicate patient fasting status on request form

Helicobacter pylori Bacteriology R

Heparin control B

Hepatitis A virus (HAV) IgG R

Hepatitis A virus (HAV) IgM R

Hepatitis B (HBV) confirmation R

Hepatitis B (HBV) core antibodies R

Hepatitis B (HBV) core IgM (anti- R HBc IgM) Hepatitis B (HBV) surface antibody R (Anti-HBs)

172

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 173 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Hepatitis B (HBV) surface antigen R (HBsAg)

Hepatitis B e antibody R

Hepatitis B e antigen R Hepatitis B virus (HBV) e antigen (HBeAg) and e antibody (Anti- R HBe) Hepatitis B virus viral load L

Hepatitis C antibody (HCV) screen R and confirmation

Hepatitis C viral load L

Hepatitis D (delta) antibody R

Hepatitis E IgG R

Hepatitis E IgM R

Hereditary Haemochromatosis Pk HFE gene mutation identification Herpes simplex 1/2 antibody (type R specific, IgM and total antibody) Herpes simplex virus types 1 and L 2 PCR

HFE Pk

HHV6 & 7 PCR L

HIV p24 antigen R

HIV screen (4th generation: HIV1 R and 2 antibody and p24 antigen)

HIV viral load L

HLA Typing R

Discuss with Biochemistry before sample collection - Homocysteine L Straight to lab without delay

HTLV 1 and 2 antibody R

Human Herpes virus 6 & 7 R

Human papilloma virus R

Human Parvovirus B19 IgG R

Human Parvovirus B19 IgM R

Human Parvovirus B19 viral load L

173

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 174 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Human T Lymphotropic virus R (HTLV) 1 and 2

Hydroxycholecalciferol G

I Blood Tubes Collection Instruction

IgA Anti-Tissue Transglutaminase R

IgD (Immunoglobulin D) G

IgE (Total) G

IGF-1 G

IGFBP-3 G

IgG Anti-Tissue Transglutaminase R

IgG subclasses G

Must be a 6ml sample tube, filled to the top and hand IGRA Gn delivered to serology by 15:30 on the day of sample collection.

IM Screen L

Immunodeficiency (T&B L L Lymphocyte Subsets)

Immunoglobin D, IgD G

Immunoglobulins (IgG, IgA, IgM) G

Infectious Mononucleosis L

Inhibin Level G

INR B

Insulin antibodies R

Discuss with Biochemistry before sample collection - Insulin Gn Straight to lab without delay

Insulin-like Growth Factor 1 G

Insulin-like Growth Factor Binding G Protein 3 Must be a 6ml sample tube, filled to the top and hand Interferon Gamma Release Assay Gn delivered to serology by 15:30 on the day of sample (IGRA) collection.

Intrinsic Factor R

174

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 175 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Iron & TIBC G

Islet Cell Antibodies R

J Blood Tubes Collection Instruction

JAK2 V617F mutation screening Discuss with Haematology before sample collection - L (qualitative) Straight to lab without delay

JC virus PCR L

Jejunal Disaccharidases G

Jo-1 Antibodies R

K Blood Tubes Collection Instruction

K (Potassium) G

Kleihauer test Pk

L Blood Tubes Collection Instruction

Lactate Dehydrogenase (LDH) G

Lactate Gr Straight to lab without delay

Lamotrigine G Indicate date and time of last dose on request form

Latex R

LDH G

LDL Cholesterol G Indicate patient fasting status on request form

Lead L Discuss with biochemistry before sample collection

Leptospira R

LH G Indicate day of menstrual cycle on request form

The time of each sample must be clearly recorded on the LHRH Series G G G blood tube - Patient to arrange appointment with Endocrine clinic

Lipase G

Lipid profile incl. total cholesterol, G Indicate patient fasting status on request form LDL, HDL, triglyceride

175

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 176 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Lithium G Indicate date and time of last dose on request form

Liver Function Tests G

Discuss with Haematology before sample collection - Lupus anticoagulant B B B Straight to lab without delay

Luteinising hormone G Indicate day of menstrual cycle on request form

Lyme Disease R

M Blood Tubes Collection Instruction

MAG (Anti Myelin Associated R Glycoprotein IgM)

Magnesium G

Malarial parasites L Straight to lab without delay

Mannose Binding Lectins R

Manual blood film L

Mast cell tryptase R

Measles IgG R

Measles IgM R

Measles virus PCR L

Meningococcal DNA detection by PCR (multiplex with Pneumococcal L DNA PCR) Meningococcal R Serology Bacteriology

Mercury Gn Discuss with biochemistry before sample collection

Discuss with Biochemistry before sample collection - Methaemalbumin Gn Straight to lab without delay

Methotrexate R

Mitochondrial antibodies R

Monospot (IM screen) L

MPO (Anti Myeloperoxidase) R

Mumps IgG R

Mumps IgM R

176

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 177 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Muscle Specific Tyrosine Kinase R (MUSK)

MUSK R

Mycobacterium PCR Bacteriology L

Mycoplasma IgM R

Mycoplasma PCR L

Myelin Associated Glycoprotein R (MAG) Myeloperoxidase (MPO) R antibodies

Myositis Antibodies R

N Blood Tubes Collection Instruction

Na (Sodium) G

Neisseria meningitidis serology R

Neuronal Antibodies (Hu/ Ri/ Yo) R

NT pro-BNP G

O Blood Tubes Collection Instruction

Oestradiol G

Oligoclonal bands G

Oral Anticoagulant Control (INR) B

Organic Acids Gn Discuss with biochemistry before sample collection

Paired test, please send urine sample and blood sample Osmolality (Blood and Urine) G together

Ovary antibodies R

P Blood Tubes Collection Instruction

P1NP G

Pancreatic Islet Cell Antibodies R

177

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 178 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Paracetamol G

Paraneoplastic Neuronal R Antibodies

Parathyroid hormone (PTH) G

Parvovirus B19 IgG R

Parvovirus B19 IgM R

Parvovirus B19 viral load L

Pertussis antibodies R pH Heparinised blood gas syringe. Take to lab without delay

Phenobarbitone G Indicate date and time of last dose on request form

Phenytoin G Indicate date and time of last dose on request form

Phosphate G

PIIINP G

PLA2R Antibodies R

Discuss with Haematology before sample collection - Plasma viscosity L Straight to lab without delay

Platelets L

Platelets Aggregation Studies Discuss with Haematology before sample collection

Pneumococcal PCR L

Pneumocystis jiroveci PCR L

Discuss with Haematology before sample collection - PNH L Straight to lab without delay

Polyoma viruses (BK) R

Polyoma viruses (JC) R

Porphyrins Gn Discuss with biochemistry prior to sample collection

Potassium voltage gated channel R antibodies (VGKC)

Potassium G

PR3 autoantibodies (cANCA) R

Pregnancy test (blood) G

178

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 179 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Primidone G

ProBNP G

Procalcitonin G

Procollagen III - NP R

Progesterone G Indicate day of menstrual cycle on request form

Discuss with biochemistry prior to sample collection. Take Proinsulin Gn straight to lab

Prolactin G

Prostate Specific Antigen G

Protein C L

Protein Electrophoresis G

Protein S L

Prothrombin time B

PSA G

PTH G

PTT (heparin control) B

Q Blood Tubes Collection Instruction

Q Fever EIA IgG and IgM R

Q Fever Serology and PCR R

Must be a 6ml sample tube, filled to the top and hand Quantiferon Gn delivered to serology by 15:30 on the day of sample collection.

R Blood Tubes Collection Instruction

Random Blood Sugar (RBS) Gr Indicate patient fasting status on request form

RAST R

Renin L Straight to lab without delay

Respiratory screen R

179

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 180 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Respiratory virus PCR L

Reticulocyte count L

Rheumatoid factor R

Rotavirus PCR L

Routine haemoglobinopathy L screening

Rubella Avidity R

Rubella IgG R

Rubella IgM R

S Blood Tubes Collection Instruction

SACE (Serum angiotensin G converting enzyme)

Salicylate G

Sapovirus PCR - enteric L

Selenium DR Royal blue with Red band on label

Serum 17-hydroxyprogesterone R

Serum ferritin G

Serum folate G

Serum free light chains G

Serum intrinsic factor antibodies R

Serum paraprotein identification/ G quantification

Serum Protein Electrophoresis G

Serum Save R

Serum vitamin B12 G

SHBG G

Sickle Test L

Sirolimus L Indicate date and time of last dose on request form

180

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 181 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Skin antibodies R

Smooth muscle antibodies R

Sodium G

Discuss with biochemistry before sample collection - Somatomedin (Growth Hormone) Pk Pk Straight to lab without delay

Staphylococcal serology - AST R

Syphilis antibody R

Syphilis IgM R

T Blood Tubes Collection Instruction

T and B lymphocyte subsets L L Discuss with Haematology before sample collection

T cell subsets L

T3 G

T4 G

Tacrolimus (FK506, prograf) L Indicate date and time of last dose on request form

TAU Protein R

Tay Sachs Discuss with biochemistry before sample collection

Testis antibodies R

Testosterone G

Tetnus response / MBL R

Thalassaemia Screen L

Theophylline R Indicate date and time of last dose on request form

Thiamine L Discuss with Haematology before sample collection

Thiopental G

Thiopurine Methyltransferase L (TPMT)

Thrombophilia Screen R B B B L Discuss with Haematology before sample collection

Thyriod receptor Antibodies G (TRAB)

181

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 182 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Thyroglobulin G

Thyroid Function Tests G

Thyroid peroxidase (TPO) G antibodies Thyroid Stimulating Hormone G (TSH)

Thyroxine - Free (free T4) G

Thyroxine Binding Globulin G

Tobramycin R

Total Protein G

Toxoplasma PCR L

Toxoplasma serology R

Toxoplasma serology (IgG) R

Toxoplasma serology (IgM) R

TPHA/TPPA R

TPMT L

TPO G

TRAB G

Transferrin (and saturation) G

Treponema pallidum (syphilis) R L PCR

Treponema pallidum confirmation R

Treponema pallidum screen R

Triglycerides G

Triiodothyronine (free T3) G

Troponin T G

TSH receptor antibodies G

TTG IgA R

TTG IgG R

182

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 183 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Type I Procollagen N-terminal G Peptide

U Blood Tubes Collection Instruction

Universal Antenatal L Haemoglobinopathy Screening

Urate G

Urea G

Uric Acid G

V Blood Tubes Collection Instruction

Valporate G Indicate date and time of last dose on request form

Vancomycin R Indicate date and time of last dose on request form

Varicella-zoster IgG R

Varicella-zoster IgM R

Varicella-zoster virus PCR L

VDRL R

VGKC antibodies R

Discuss with Biochemistry before sample collection. Vitamin A (retinol) R Protect from light and straight to Lab

Vitamin B12 G

Vitamin D G

Discuss with Biochemistry before sample collection. Vitamin E (Tocopherol) R Protect from light and straight to Lab Voltage-gated Calcium Channel R Antibodies Voltage-gated Potassium Channel R Antibodies von Willebrand factor activity B B B Discuss with Haematology before sample collection

VZV antibodies R

183

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 184 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

W Blood Tubes Collection Instruction

West Nile Virus R

White Cell Enzymes Discuss with biochemistry before sample collection

Whooping cough R

WR (Wassermann reaction for R Syphilis)

X Blood Tubes Collection Instruction

X Match Pk 2 samples required, taken 30 minutes apart

Xa inhibition B Discuss with Haematology before sample collection

Y Blood Tubes Collection Instruction

Yellow fever R

Yersinia R

Z Blood Tubes Collection Instruction

Zinc DR Royal blue with red band on label

Discuss with Biochemistry before sample collection. Zinc Protoporphyrin Gn Protect from light and straight to Lab Discuss with Biochemistry before sample collection. ZPP Gn Protect from light and straight to Lab

184

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 185 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

MINIMUM REPEAT INTERVALS FOR DIRECT ACCESS PATHOLOGY INVESTIGATIONS

The tables that follow represent clinical and laboratory practice of members from the clinical expert panels for pathology modernization. However, it should be noted that these time intervals are quoted as a guideline and that where the clinical condition or symptoms change, it may be appropriate to investigate more frequently than the interval quoted.

Biochemistry

Investigation Minimum repeat interval Primary Care Adrenocorticotrophic Hormone 14 days (Not appropriate in primary care) Albumin 14 days Albumin Excretion 14 days Albumin/Creatinine Ratio (urine) 180 days Alkaline Phosphatase Isoenzymes Once only (Not normally requested in primary care) Alkaline Phosphatase 14 days Alpha-1-antitrypsin phenotype Once only Alpha-Feto Protein 180 days for HCC surveillance, 90 days for HCC recurrence monitoring Amiodarone Limited use, check TFT and liver profile for safety monitoring 180 days Amylase 14 days Angiotensin Converting Enzyme 14 days (Not appropriate in primary care) Aspartate Transaminase 14 days Bicarbonate 14 days Bilirubin (Conjugated) 14 days Bilirubin (Total) 14 days Biochemistry ( Liver Profile) 14 days Bone profile 14 days CA125 30 days monitoring for reoccurrence CA153 60 days monitoring for reoccurrence CA199 30 days monitoring for reoccurrence Calcium 14 days Carbamazepine levels For the AED drug -Once only unless change in dose or toxicity suspected Catecholamines (urine) 30 days (Not normally tested in primary care) Catecholamines (plasma) 30 days (Not normally tested in primary care) Cortisol 14 days

185

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 186 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Investigation Minimum repeat interval Primary Care Cortisol (24 hour urine) 14 days C-reactive Protein 14 days Creatine Kinase 42 days Creatinine 14 days Digoxin level Once only, unless change in dose or toxicity suspected Follicle stimulating hormone 180 days Ferritin 30 days Flecanide Once only, (Not normally tested in primary care) Folate (serum) 120 days Folate (red cell) 120 days Gamma-glutamyl Transferase 90 days Glucose (blood) 14 days Glycated Hb / Haemoglobin A1C 90 days Growth Hormone IgF1 365 days for acromegaly monitoring; 90 days if there has been a change in medication Iron (serum) 30 days Lipid profile 180 days if normal; 42 days to monitor therapy Lithium 90 days Liver profile 14 days Magnesium 14 days Mercury 14 days N terminal pro-BNP Once only unless repeat episode Oestradiol Once only (Not normally tested in primary care unless on IVF treatment) Osmolality (random urine) 14 days Osmolality Plasma 14 days Parathyroid Hormone, Intact 14 days (Not normally tested in primary care) Phenobarbitone levels For AED drug - Once only, unless change in dose or toxicity suspected Phenytoin levels For AED drug - Once only, unless change in dose or toxicity suspected Phosphate 14 days Potassium 14 days Progesterone 120 days Prolactin 30 days (may need repeat after 1 month post dopamine agonist therapy or query drug induced hyperprolactinaemia) Prostate Specific Antigen 180 days for monitoring Protein blood 14 days Renal profile 14 days Sodium (blood) 14 days Testosterone 120 days Theophylline levels Once only, unless change in dose or toxicity suspected Thyroglobulins 180 days for thyroid carcinoma surveillance Thyroid Function Tests 120 days Total Iron binding capacity (TIBC) 30 days

186

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 187 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Investigation Minimum repeat interval Primary Care Total Protein 14 days Urate (blood) 120 days Urea (blood) 14 days Valproate levels For AED drug - Once only, unless change in dose or toxicity suspected Vitamin D (25-hydroxy) Once only, unless new episode of abnormal symptoms Vitamin B12 365 days if normal/90days if abnormal Zinc Baseline, then 30 days depending on results

Haematology

Investigation Minimum repeat interval Primary Care Blood Film 30 days Coagulation Screen 14 days D-Dimer 14 days ESR 14 days Full Blood Count 14 days Glucose - 6 - Phosphate Dehydrogenase 90 days Screen Haemoglobinopathy Screen Once only if conclusive and patient identity can be assured on each occasion and any blood transfusion history is known. Infectious Mononucleosis/Glandular 7 days if negative and symptoms persist Fever Screen Lupus Anticoagulant 84 days Malaria Screen 24 hours; up to 3 screens if negative and if symptoms persist Prothrombin Time 14 days Reticulocyte Count 7 days Sickle Screen Once only if conclusive and patient has not had a blood transfusion Thrombin Time 30 days

Immunology

Investigation Minimum Repeat Interval Primary Care Adrenal Antibodies 180 days Antinuclear antibodies (ANA) 90 days Double-stranded DNA Antibodies 30 days (only if positive ANA) Extractable Nuclear Antigens Generally single test sufficient Acetylcholine Receptor Antibody Generally single test sufficient Glomerular Basement Membrane Ab 30 days Anti Neutrophil Cytoplasmic Antibody 30 days (ANCA)(Including proteinase 3 and myeloperoxidase antibodies) Tissue Transglutaminase (or other 30 days coeliac) antibody

187

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 188 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Investigation Minimum Repeat Interval Primary Care Ganglioside Antibody Generally single test sufficient Cardiolipin Antibody 90 days CCP Antibodies 180 days C3 14 days C4 14 days C1 Esterase Inhibitor Generally single test sufficient Immunoglobulin E 180 days Immunoglobulin G Subclasses 365 days Immunoglobulins (IgGAM) 90 days Gastric Parietal Cell/ Intrinsic Factor 180 days Antibody Smooth muscle antibody Generally single test sufficient Mitochondrial Antibody Generally single test sufficient Lymphocyte Subsets (T,B, NK) 30 days Mannose Binding Lectin Generally single test sufficient Ovarian Antibodies Generally single test sufficient Serum Electrophoresis 14 days Serum Free Light Chains 14 days Rheumatoid Factor Generally single test sufficient Thyroid Peroxidase Antibodies 365 days Generally single test sufficient: this comment is for unchanged clinical symptoms. Should clinical symptoms change significantly, then repeat testing may be indicated.

Microbiology and Virology

Investigation Minimum repeat interval Primary Care AFB culture for TB When clinically required Bordetella pertussis DNA When clinically required Chlamydia NAT New clinical episode Clostridium difficule toxin New clinical episode Cytomegalovirus IgG Once only if positive Cytomegalovirus IgM Once only if positive Epstein Barr virus Antibodies Once only if positive Fungal culture New clinical episode Helicobacter pylori antigen (faeces) New clinical episode Hepatitis A IgG Once only if positive Hepatitis B core antibodies Once only if positive Hepatitis B surface Antigen Once only if positive Hepatitis B virus immunity Once only if positive Hepatitis C Virus Antibodies Once only if positive High Vaginal Swab New clinical episode Human Immunodeficiency Virus Once only if positive. If negative, repeat testing Antibodies within 90 days may be appropriate as seroconversion may take up to 3 months. Legionella antigen New clinical episode Measles virus IgG antibodies Once only if positive Measles virus IgM antibodies Once only if positive, but if negative and IgG positive, never again

188

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.

Whittington Health Version: 2021.1 MB 129 Microbiology Department Author: Service Managers Page 189 of 189 Print Date: 27 April 2021 Authorised by: DW Issue Date: 26 April 2021

Mumps serology IgG Once only if positive Mumps serology IgM Once only if positive, but if negative and IgG is positive, never again Rubella Virus IgG Antibodies Once only if positive, but should be repeated in each pregnancy Syphilis IgG/M If TPE is negative - repeat if at risk of recent infection Varicella Zoster IgG Once only if positive

Virology - generally, there is never a need to retest for viral antibodies if the result is positive. If negative, retesting will only be indicated if a new clinical episode occurs, or in the case of future pregnancies, this may be repeated. Bacteriology - Repeat should only be required if there is a new clinical episode. for further guidance go to www.hpa.org.uk/Topics/InfectiousDiseases/InfectionsAZ/PrimaryCareGuidance

Guidance has been issued by the Royal College of Pathologists Minimum retesting intervals in pathology.

189

The master document is controlled electronically. Printed copies of this document are not controlled. Document users are responsible for ensuring printed copies are valid prior to use.